Reducing alcohol-related harm in disadvantaged men: development and feasibility assessment of a brief intervention delivered by mobile telephone

Sampling

In accordance with best practice for qualitative research we sought to implement a maximum variation sampling strategy which would achieve diversity in key variables for which views and experience around alcohol would likely differ. 43 Research elsewhere has suggested that the profile of drinking behaviours varies by age; consequently, within our age group (25–44 years) we sought to ensure individuals were represented in both the 25–35 years and 36–44 years age bands. In addition, we sought to include a number of individuals who may be aged between 44 and 60 years in order to obtain their views on past behaviour (with the experience of hindsight).

Recruitment

We purposively sampled from a variety of social venues likely to represent the target group of interest to the study. Venues included Saturday amateur football league clubs, public houses, an employment training centre and a further education college (Table 1). Systematic reviews have shown that the provision of monetary incentives can significantly increase recruitment to research studies. 44,45 Consequently, men agreeing to take part were given a £10 gift voucher and travel expenses. They found the experience rewarding because a prestigious organisation (the university) was interested in their lives and believed what they had to say was valuable. Many said it was therefore something they could share with pride in their social network.

Thus, 28 men aged 21–57 years living in areas of high deprivation were recruited to the study. Deprivation was measured using the Scottish Index of Multiple Deprivation (SIMD),46 which is similar to the English Index of Multiple Deprivation. Individual-level socioeconomic position was also assessed from brief questionnaires on current socioeconomic and demographic characteristics. Summary characteristics of participants are shown in Table 2.

Data collection and analysis

Data were collected using a focus group approach. It was clear that much drinking reflected a social practice influenced in part through group norms and sets of social expectancies. Consequently, enabling men to talk as a group would enable identification of these expectancies, attitudes and values. 47 A topic guide was constructed based on a background search of relevant literature in the area. However, conversations were not limited to these areas. All participants were informed of the confidential nature of the research. All groups were audio-recorded and transcribed. Analysis was conducted by three members of the research team (JC, DWF and BW) using the framework approach. 48 Pseudonyms have been used in direct quotations to protect participant identity.

Private purpose and social roles

Our findings suggest that alcohol consumption behaviours vary in accordance with two parallel drivers: private purpose and public role. Private purpose refers to an individual's personal reasons for and against particular forms of alcohol consumption. While these purposes may sometimes be made public, they are generally tacit. Public role highlights the social role of alcohol in many individuals' lives. As with any role it brings a set of social expectations and duties which must be followed if sanctions are to be avoided. Private purpose may be seen to be a driver of private drinking, while social drinking may be influenced by both private purpose and social role.

Shifting purpose and role – the importance of age

Participants frequently generated a narrative looking back to earlier times in their lives; in addition, they sometimes compared their own motives, experiences and behaviours to other contemporary younger drinkers. Through these comparisons it became clear that they perceived a very significant shift in both the social role expectations and duties, and the private purpose motives for drinking. Consequently, there was a move towards what might be termed the ‘mature drinker’. Indeed, these were sufficiently consistent as to suggest that there may broader agreement on the existence of younger and mature drinker roles. This shift is shown in Table 3.

There was a general view that older drinkers were less likely to be drinking in order to get drunk and more likely to drink for general relaxation, social company, reward and as a means of escaping from daily pressures. In addition, older drinkers saw themselves as more able to know their limits and more likely to be able to ‘hold’ their drink. Some felt that they had more money to drink now that they were older while others found that finance was a major obstacle. Consequently, these drivers meant that more mature drinkers might well consume greater volumes of alcohol but be drunk less frequently.

Although these issues suggested that greater quantities of alcohol might frequently be consumed, there were multiple examples of explanations of changes in drinking behaviour rooted in the adoption of multiple new social roles which competed and were sometimes incompatible with their past drinking behaviours. These provided a new and perhaps wider ‘perspective’ on the role and impact of alcohol in their lives:

Yeah because maybe if you're seeing a lassie, you’ll maybe get a bottle of wine and a DVD or have a glass of wine with my tea most nights or a couple of beers maybe watching the Champions League. You've got a different perspective on drink because you’re older.

Simon, aged 27 years

A commonly reported shift was with regard to their obligations within family roles and relationships. This included both partners and children:

But you do, even like when kids come on the scene, if you’ve got your partner, you split up, you get your bairn one week, you get the bairn weekends. That changes yourself as well. That’s like me, I get [inaudible] every weekend, so I don’t go out. I go out every Wednesday, that’s when I got out.

Fred, aged 34 years

More frequently expressed were their current identities and obligations as employees. When they were younger such responsibilities were not of concern, but now they constrained what the men could do:

With my job and responsibilities, I can’t just go out, I’m not working in a warehouse like I was when I was 18 where you can just do what you want the next day, it doesn’t matter. But now, during the week, it just can’t happen, with my job the next day, I just couldn’t function properly.

Jim, aged 31 years

There was recognition that the adoption of these wider life roles and responsibilities were appropriate and to be expected as part of the process of becoming more mature. They were not expressed in pejorative forms and there was little sense of nostalgia about what they were losing in terms of past drinking behaviour. Consequently, even among those older men who were still drinking significantly there was a willingness to publicly express their intention to change as these new roles emerged for them:

Well I don’t want to be, my ideal at some point would be to settle down and have some sort of family unit that my focus was on them, and go for the occasional night out with the boys and the odd couple of pints. But certainly not drink socially the way we drink now and I wouldn’t want to be drinking to that extent when I get older. I’m not saying I might, what I want and what will happen might be two different things but certainly, for the picture of where I want my life to go I don’t want to be still having the nights out the way I have them just now in say 5–10 years’ time. I would rather want my focus to be somewhere more important.

Simon, aged 27 years

Awareness of consequences and the importance of concrete personal experience over abstract risk

High levels of alcohol consumption among the older men do not appear to be rooted in a lack of awareness of the consequences of drink. There was ample evidence, and graphic examples, of the consequences including hangovers, significant financial cost, changed character, poor health and violence with its associated implications.

Underpinning many of the consequences was recognition that during the drinking process their usual selves, with their typical motives, intentions, values and self-discipline diminish, culminating with a complete disappearance and a lack of awareness or memory of anything that occurred:

Your judgement could be all wrong.

Martyn, aged 38 years

You forget a lot, you don’t ken what you’ve done. You lose your identity as well because you don’t know what you’ve done.

Derek, aged 28 years

Yeah me, I have. Quite a few years ago. I was out with a mate, a friend of mine and ended up having quite a few drinks and the next thing I knew I woke up in hospital.

Jeff, aged 40 years

I woke up in Orkney Street in Govan and I thought ‘How did I get here?’

Brian, aged 31 years

Consequently, while alcohol had been described as facilitating the achievement of social roles and valued personal identity in their earlier years through improved social confidence (‘freedom to’), alcohol now frequently proved to be an obstacle to achieving such an identity (partly because that valued identity had changed as new domestic, work and even the mature drinker role had been adopted). Ultimately, it was seen to change one's character and desired behaviours:

I think it hampers your personality on all points, and that’s not always a good thing. I mean, you can say things you regret or those feelings that have been sitting on your mind or your boss, maybe you shouldn’t say something if you’re at a work night out, or a girl, that you’d maybe regret the next day, when you've left a text or a comment on a social network site or anything. And you’re like, this seemed like a good idea at the time. . . [laughter]

Tony, aged 28 years

My dad said to me at one point, he says, I always know when you’re back on the drink or drugs, you’re an obnoxious little shit.

Ross, aged 37 years

. . . she just says ‘I don’t like you when you drink, I don’t like your attitude and the way you are.’ She says I get quite aggressive.

Jim, aged 31 years

The most common seemingly powerful consequences of alcohol consumption for participants were in relation to aggression and physical violence. Many participants knew of others who had been in trouble with the police (including assault and murder), while others had personal experience:

Yeah. I’ve been arrested and put in the cells overnight and stuff like that. I’ve been in quite a few fights because of it, so.

Ben, aged 38 years

When I used to drink, if I drank whisky, it just made me drowsy. I’d get a heavy hangover and I’d probably start fighting with somebody.

Graeme, aged 43 years

Although there was widespread awareness of a range of negative consequences from alcohol consumption, it was interesting to note that explanations for changes in participants' drinking were rooted in past personal experience of these issues rather than knowledge of their more abstract existence and risk. The most important of these appeared to be the impact on the person's children, although multiple causes were often seen to combine.

The main reason for me is one, no more criminal record. Two, I’ve got two children that I haven’t seen for two years now. And obviously the money as well. And health. My brother’s only 40 and he drinks and he had a stroke last year, so that’s a bit worrying when you’ve got heart problems in the family as well, so I thought, I’ll stop as well, so.

Ben, aged 38 years

Other reported triggers to changing included the financial impact, e.g. falling behind in paying bills, and personal health events. Although most examples related to the individual's own personal experience of a substantive problem, a few individuals did indicate that it was the observed experience of a close friend or relative which had prompted their change in drinking. In earlier discussions regarding consequences of excessive drinking, participants frequently reported the consequences that they had observed in other people; however, observations only appeared to motivate actual reported change in the participant when it was someone close to them. This suggested that in some instances vicarious experience may prompt change, or at least intentions to change consumption patterns.

The importance of the ‘mature drinker’ role

Our data suggest that contemporary society may have a particular set of expectations and beliefs about the more ‘mature drinker’: someone who can tolerate greater amounts of alcohol without becoming drunk, has greater self-discipline, is more likely to be able to resist social pressures to drink, and drinks as a means of reward, relaxation and release. The existence of such a set of social expectancies is perhaps evident in the way society may interpret public drunkenness by a teenager or person in their early 20s differently compared with a man in his 40s. The existence of the ‘mature drinker’ role and the individual's desire to conform/live up to the identity it affords may prove useful in both behavioural interventions and those employing more social marketing approaches. 49,50

The development of competing social roles and identities as an explanation for changes in drinking behaviour with age

Our findings also show that reasons for alcohol consumption among older disadvantaged men differ from their younger counterparts. Therefore, brief interventions to tackle the problem must incorporate different approaches. The literature suggests the perceived benefits of alcohol (alcohol expectancies) for young people include mood enhancement and enjoyment, stress relief and escapism, easier socialising and social success, and conformity with peers. 51,52 Thus, three different types of drinkers have been identified: enhancement drinkers, social drinkers and coping drinkers. 53 Although similar benefits were stressed by the older men in this study, there was a clear shift in emphasis away from the use of alcohol as a means of achieving valued social identities, social confidence and group membership (‘freedom to’), towards a greater value attached to the use of alcohol as reward, relaxation and release (‘freedom from’). Such changes were clearly rooted in changes in social identities and roles acquired as men grew older. They became employees, partners and fathers – roles and responsibilities which had the potential to constrain alcohol consumption, or at least excessive drinking. The existence of these competing roles as a constraint may provide a means through which potential behavioural interventions may operate. The power of social roles to influence behaviour comes from the potential social sanctions applied when expectations and duties associated with those roles are not fulfilled (e.g. failing to be a good employee, partner or parent). 54 Consequently, the psychological concept of ‘subjective norm’ (an individual's perception of social normative pressures, or relevant others' beliefs that he or she should or should not perform such behaviour55) may be helpful in future behavioural interventions for this population.

Studies have shown that peer pressure is a significant factor in the level of alcohol consumption among young people. 56 Low levels of drinking refusal self-efficacy have been found to increase the acquisition and maintenance of binge drinking. 57 However, the adult version of the Drinking Motives Questionnaire (DMQ) has no scale to measure peer (conformity) motives, because it assumes the influence of peer pressure declines with age. 53 Although this, to a large extent, is true, our findings suggest the influence of peers and social networks on the older cohort may be more complex and subtle than first assumed. Although some men felt that their friends were more accepting of their decisions to slow their drinking down, other men still felt pressure from their peers to consume large amounts of alcohol. In the second context it was the behaviour – the consumption of alcohol – that signified membership of the group and gave the men a sense of belonging. The men's refusal self-efficacy therefore largely depended on whether the group was predominantly defined by its drinking behaviour or another organising factor. A brief intervention might therefore highlight that the men have a choice about the different social networks they are accessing, and that this choice will affect the amount of alcohol they consume and ultimately their health and well-being.

Alcohol and role incompatibilities: the potential of ‘developing discrepancy’

Drinking was a component of many rituals that were deeply satisfying to the older men in the study, and which reinforced the pleasure because of this association. Yet many of the benefits the men identified were not compatible with being very drunk. This presents an opportunity to highlight the inconsistency between an individual's drinking habits and the intended aims of drinking. Thus, brief interventions could highlight the mismatch between being drunk, and success in socialising, working, ‘doing good turns’ and feeling good about oneself. The utilisation of such discrepancies is at the centre of MI, suggesting that this approach may be effective, or at least a contributory approach, to behavioural strategies in this area. Indeed, the efficacy of MI in addressing drinking behaviours has demonstrated success in meta-analyses,58 and the feasibility of implementing it through brief intervention formats has been shown. 59

Concrete personal or vicarious experience as a trigger for behaviour change

Young people tend to believe that they will not come to harm, and that drinking will have few negative consequences. 51 Thus, they are unlikely to modify dangerous drinking habits because they do not perceive themselves as being susceptible to harm. On the contrary, such beliefs are associated with increased levels of consumption. 60 However, in marked contrast, the older men in our study believed they were susceptible to (or had actually experienced) the health and social consequences of excessive alcohol consumption. The most frequently cited negative consequences were the risk of injury or criminal record (through aggression and violence); serious illness (such as liver disease or stroke); family disruption and separation; and financial drain. Critically, a minority believed that any health damage was irreversible and therefore saw little point in reducing alcohol consumption.

However, although acknowledgement of the existence of these dangers was widespread, it appeared only to be those who had experienced them personally (or vicariously through a very close family member or friend) who reported them as a driver to behaviour change. This finding is unsurprising given both behavioural theory and empirical research elsewhere that suggests that beliefs that are less abstract and experientially more concrete are more likely to result in behaviour change. 61,62 Consequently, any intervention needs not only to present the true risks of alcohol, but wherever possible to ensure that this is expressed in non-abstract and more direct or even concrete/experiential terms. This may include anything from the use of graphics over abstract text, through to reminding people of key past negative personal experiences of alcohol and its impact on others. Although some participants were sceptical regarding the use of images in interventions, this centred primarily on the potential ambiguity of meanings within images compared with clear text. This is clearly important. Indeed, issues of what is now termed ‘visual literacy’ are well acknowledged and must be taken into consideration when designing any images. 63 Where such personal experiences do not exist then utilising those of close family, friends or even well-known and liked public figures may prompt similar results through vicarious experience. The potential of vicarious experience has been little studied but empirical evidence in other behavioural contexts suggests there may be potential for its use. 64 The potential of concrete personal experience as a motivator also raises questions regarding whether or not coinciding the timing of the delivery of the intervention to a point soon after any such experience may significantly improve its effectiveness. Certainly, concepts such as ‘triggers to action’65 and, more recently, the idea of the ‘teachable moment’66,67 would support this.

The theory of planned behaviour

The TPB has been widely used to predict intentions and behaviour. 12,71 It states that intention is the proximal determinant of behaviour and that the three main influencers of intention are attitudes, subjective norms and perceived behavioural control. 72 Attitudes are determined by beliefs about the desirable and undesired consequences of a behaviour, which lead to an overall evaluation of the behaviour. Subjective norms are the beliefs about the views of significant others (approval or disapproval). Perceived behaviour control was initially regarded as the extent to which internal factors, such as skills, and external factors influenced the individual's perceived control over the behaviour. More recently, perceived behavioural control has been subdivided into two factors:73 self-efficacy, that is, confidence in one's ability to perform the behaviour and the extent to which carrying out the behaviour is easy or difficult; and perceived control, perceptions of control over the behaviour and the extent to which the performance of the behaviour is within the individual's control. 74

Binge drinking has been extensively studied using the TPB,72,73,75 with implications for interventions to change behaviour. As attitude is a strong predictor of intention, focusing on the negative consequences of binge drinking has great promise. 75 Negative consequences are often described as negative alcohol expectancies and include hangover, vomiting, aggression and accidents. 76 These negative expectancies could be portrayed in text messages, encouraging participants towards preventive strategies. Subjective norms are another target to facilitate behaviour change. Although difficult to change at a population level, it would be possible to increase the salience of the views of significant others (parents, partners, close family) to encourage more moderate drinking. To ensure the significant other holds a more moderate view of drinking, the text message would need to direct the participant to those who would be pleased with a reduced consumption. Increasing drinking refusal self-efficacy is another promising approach. 77 Finally, the intervention could try to reinforce both self-efficacy and perceived behavioural control. Self-efficacy could be bolstered by acknowledging that change is difficult, while supporting continued effort for even modest improvements.

Motivational interviewing

Motivational interviewing was developed from clinical experience in the treatment of problem drinkers. 13 Recent meta-analyses have shown that it is an effective technique for treating problem behaviours. 36,58 It is a style of counselling that promotes behaviour change by helping individuals to decide for themselves that they wish to change. 13 Although it is directional, in that it seeks a specific behaviour change, MI avoids confrontation, or coercive approaches to behaviour change. 14 These are thought to make individuals defensive, increasing resistance to change. Instead MI empathises with individuals, recognising the legitimacy of their viewpoint while encouraging them to identify personal advantages of changing behaviour. Two further techniques are crucial to this approach. The first is to identify discrepancy between what the individual wants from a behaviour and the adverse outcomes which sometimes occur. For example, when drinking most people want to have fun and socialise, whereas if they become very drunk, arguments, violence or even physical collapse can prevent achieving the desired goals. MI encourages the individual to identify and describe this discrepancy for themselves, leading to a personal choice to change. That the individual, rather than the counsellor, identifies the need for change is seen as crucial to MI. 58

A second technique is to promote self-efficacy, an individual's belief in his or her ability to change behaviour. This can be done by encouraging individuals to make positive statements to reframe thinking about a behaviour. 78 Statements from the counsellor which affirm that behaviour change is difficult and that the individual should persevere under difficult circumstances can also promote self-efficacy. Another approach is to ask what would be the best outcome if behaviour were to change.

Motivational interviewing is traditionally delivered face to face,36 but it provides an attractive style for the design of the text messages. It suggests that approaches that emphasise autonomy, empathy and self-efficacy and avoid authority and adversarial content might be more effective and more acceptable. The emphasis on empathy would minimise any perception of the intrusiveness of the messages. This could occur with messages which were unsolicited and from an unknown source. The techniques of encouraging individuals to pursue discrepancies in their drinking behaviour, combined with improving self-efficacy also identify important content for the messages. Two other techniques of MI, avoid argument and roll with resistance, were deemed inappropriate for a text message intervention.

The approach of MI emphasises that advice giving should be avoided. This conflicts with the design of many brief interventions, particularly when delivered by health professionals, in which advice giving and an implicit appeal to professional authority are key ingredients of the behaviour change strategy. 9,68,79 Given the nature of the target group, healthy disadvantaged young men with few concerns about their drinking, avoidance of advice giving seemed the better choice. This view was supported by the focus group study, which showed the text messages offering tips to reduce drinking were unpopular.

The transtheoretical model

The TTM was developed in the 1970s as a synthesis of therapeutic approaches to behaviour change into a comprehensive model of change. 80 It has been used to explore change in drinking behaviour among individuals with alcohol problems. 81,82 It identifies a series of stages of readiness to change: from pre-contemplation (not thinking about cutting down), to contemplation, to preparation to change, to active behaviour change. 83 Motivation is seen as central to behaviour change84 at all stages of change. The model is driven by processes specific to each particular stage. These include: validating lack of readiness to change, encouraging re-evaluation of current behaviour, encouraging self-exploration not action, explaining and personalising risks, evaluating pros and cons of change, promoting new positive outcome expectations, helping identify and remove obstacles, helping patients identify social support and bolstering self-efficacy. 85

Reviews of behaviour change theories

Some recent reviews of theories of behaviour change have been concerned with giving guidance for the construction of interventions to change behaviour. One study identified, from a range of theories, a set of 12 theoretical constructs which explained behaviour. 86 A further study linked theoretical constructs to specific behaviour change techniques. 16 Another approach was to review the techniques commonly used in behaviour change studies, identifying those with theoretical support. 15 This led to a set of 26 defined techniques linked to specific theories. Finally, an evaluation of alcohol education leaflets identified 48 categories of message. 87 This was reduced to a set of 29 categories of message which target cognitive antecedents of drinking. Together these studies provided explicit descriptions of theory-based behaviour change techniques. These helped inspire the creation of text messages and provided a checklist against which the intervention messages could be compared to ensure that important techniques were not omitted. As expected,15 not all the techniques were appropriate for the target group or for delivery by text message. However, as the authors of the reviews suggested, identification of these techniques greatly aids the development of behaviour change interventions.

Communication theory

The design of the text messages was based on current communication theory. This draws attention to the series of steps from message receipt to behaviour change. To be effective a message must be attended to, comprehended, processed, accepted and acted on. 88 Communication theory identifies four features of a message which affect the likelihood of behaviour change: the source (i.e. credibility) of the message, its style and content, the nature of the recipient and the context (the circumstances in which the message is received). Each of these features affects the impact of the message on behaviour change. 89,90 The nature of the message comprises many facets, including its length, content (number of arguments), language and style (such as use of images). Important design features are the personal relevance of the message89 and whether the arguments are gain-framed (emphasising the benefits of moderate drinking) or loss-framed;91 gain-framed messages are much more persuasive in altering behaviour. Items can also be included to maintain interest (such as interesting and unexpected statements).

Credible source

The University of Dundee provided a credible source for the research project. The university logo was printed on all letters sent and appeared in the first text messages of the intervention. Thus, the introductory text used the university identity to welcome participants to the study. ‘Welcome, Dave! U are 1 of 60 men chosen by Dundee University for this important study on alcohol use’. This text had the additional benefits of making the men feel valued and building rapport.

Style and tone of the messages

The messages employed a simple, non-academic, friendly and non-confrontational language. Some messages contained quotes from the focus groups, suitably anonymised. The style of the messages changed across the intervention. The first text was a friendly welcome to the study using the participant's name, and the following texts were supportive, establishing rapport and making the men feel valued. However, the texts then became progressively more serious with the final messages emphasising the importance of behaviour change. The final text thanked the men for participating in the study.

The personal pronoun ‘you’ was used throughout, as it increases personal relevance and the processing of message arguments. 94 An early decision was to construct messages according to the conventions of texting, and to use the language of the target group. For example, the letter ‘u’ was used in place of ‘you’ and capitalised as ‘U’ to make it stand out. The abbreviated forms ‘it's’, ‘don't’, ‘I'll’ and ‘they're’ were used to create informality, but had the additional benefit of saving characters.

Unlike previous studies,23 no messages were repeated. Furthermore, the type and content of the messages was varied from day to day to maintain interest. Some messages were included because they might not be expected. For example, one text introduced a little-known side effect of heavy drinking, that it can cause ‘man boobs’ (male breasts).

Humour

Humour is thought to increase attention to messages, to increase their persuasiveness and to make them more memorable. 95,96 Humour was primarily used during the first 2 weeks of the study to engage the interest of the participants and build rapport with them. The jokes were designed to have sufficient appeal to be the kind you would want to show to your friends. Sharing texts would reinforce the impact of the message, increasing its salience and enlisting peer support for the study. As the target group was young to middle-aged men the humour had to be grounded in popular culture and included references to drunkenness and to sexual activity.

Tailoring of text messages

Tailoring is an essential feature of text messages. First name, or preferred name, was used for the first two and last two text messages of the intervention. Many messages reflected the drinking culture of the men which had been identified in focus groups, including drinking episodes with unfortunate consequences. The focus groups also provided examples of telling phrases which were used (anonymously) in the text messages. For example, one text used the expression of regret the day after a drinking session: ‘Many a weekend I've thought if I'd just went home at 8–9 p.m., I wouldn't be sitting here now feeling like a bag of shite’. When used, these quotes were attributed to individuals. To preserve anonymity individual names were replaced by the five most popular names given to babies born in Scotland in 1975; this was the mid-point of the years of birth of the study participants, 1966–85.

Gain-framing of messages

Conveying the adverse consequences of heavy drinking will help motivate participants to reduce their consumption. However, there is clear evidence that gain-framed messages are more effective than loss-framed ones. 91,97 To avoid loss-framing the messages about harms were frequently extended to conclude with the benefit of avoidance behaviour. For example, a text on the high death rate from alcohol was extended to wish the participant a long and healthy life. Similarly, the text on the high cost of alcohol was turned round to conclude with the amount that could be saved by cutting consumption.

Images

Images can enhance the coherence of the message (i.e. more clearly demonstrate how cause and effect are linked) by making behaviours and their consequences appear less abstract and more concrete. They can also help extend the narrative being developed, a particular benefit for short text messages. Images are often more memorable than verbal- or text-based messages. 98,99 In short, images can influence attitudes100,101 and intentions, thus increasing the likelihood of behaviour change.

Seventeen images, selected to be bright and colourful, were sent as MMS messages. They were designed to develop and extend the narrative and to make concrete the many harms of alcohol: impotence, vomiting, violence, crime, liver cirrhosis and death. For example, the way in which alcohol can make a peaceable individual aggressive was illustrated with a popular cartoon character, the Incredible Hulk™ (Marvel). The image of a jail was thought to be a powerful adjunct to a text conveying the risk of crime associated with heavy drinking. To ease the harshness of the message, a cartoon of the Monopoly™ (Hasbro) ‘Go to Jail’ character was used.

Paired messages

Five paired text messages, with the second message sent 3 minutes after the first, were used. This extends the time participants have to think about the content of the message. The device has several purposes: to enable more complex messages to be sent, to reinforce important concepts, and to extend the narrative of the previous message. For example, one text was used to seed an idea (a joke about the harms of alcohol) while the second encouraged reflection on the topic (i.e. can they think of any reasons for cutting down). This approach also introduces an element of novelty; when the participant opens a new message he cannot know whether a second will shortly follow.

Relapse

Two text messages to address relapse were built into the intervention. Relapse is common during behaviour change, particularly with behaviours like alcohol consumption. Individuals progress through the stages of change but often relapse to an earlier stage. 85 Thus, relapse was presented as a likely outcome: ‘If U aim to drink a little less on a night out but end up pissed, don't give up, it happens. Just try your best next time. Take care!’ The message provided encouragement on coping with unsuccessful attempts at cutting down.

Number, frequency and timing of message delivery

The question of when messages should be sent was resolved through an initial review of the target behaviour followed by testing of possible delivery schedules in the focus groups. Drinking patterns vary across the week, offering opportunities for different types of intervention. As many people drink more heavily at weekends, this creates two opportunities: early Friday evening before heavy drinking has started; and late morning or early afternoon on Sunday when drinkers experience regrets about the excesses of the previous nights. Between weekends there is a period of relative calm when mature reflection about the costs and benefits of drinking could be encouraged. The mid-week period is the time when a longer-term perspective can be taken on issues like money, relationships and health. Messages were designed to tap into these three opportunities: before drinking, after a heavy drinking episode and mid-week sobriety. Friday texts were sent at 1800 and Saturday texts at 1300–1400, in both cases before clients go out drinking. Sunday texts were generally later in the evening to give the participants a little more time to recover from a hangover. Mid-week texts, Monday to Thursday, were sent at selected times between 1200 and 2100. The aim was to avoid predictability.

A key question is the optimum number of messages to promote behaviour change: too few and the intervention will be ineffective, too many and messages will be unread with the risk that participants will withdraw from the study. The feasibility study opted for a moderate number of texts, 36, spread over a 28-day period. Thus, one message was sent each day but two introductory texts were sent on the first day and on five days pairs of linked messages were sent.

Interactivity

Conventional brief interventions involve a conversation between researcher and participant in which drinking motives, benefits and harms can be reviewed. Studies with automated delivery of text messages limit the opportunities for interaction. Questions can easily be incorporated into text messages and interactivity is a prominent feature of SMS-delivered interventions. 23 However, there is no opportunity to continue the dialogue, which restricts the use of questions to conversation-terminating events. An alternative approach is to take advantage of the finding that questions provoke more reflection on issues than statements or assertions. 102–104 Thus, questions were used to encourage participants to think about the key steps in the process to behaviour change: the potential benefits of drinking less, the people who would be pleased about moderated drinking (subjective norms) and self-efficacy about reducing drinking. A few questions were used primarily for humour to prevent messages being equated solely with serious issues.

Supplementary materials

Supplementary materials, such as websites and e-mail, could add to the effectiveness of an intervention. However, this potential gain is not without cost; it increases the demand placed on participants to access and use these materials. Making engagement with the intervention onerous was not attractive for this study. In studies of patients in clinical care, the additional burden of the supplementary materials might be welcomed because of perceived clinical need. This study recruited healthy individuals who were not seeking help for alcohol; they could potentially resent the invasion of their personal space. 23 Furthermore, using e-mail or websites to supplement the text messages would require daily access to an online computer, a facility which might not be available to all disadvantaged men. It was decided that the study should make as few demands on the participants as possible and thus supplementary materials were not used.

Control group messages

The aim of the control group messages was to promote engagement with the study and help retain individuals within the study. At the outset of the study participants were told that they were being recruited to a study on health and on alcohol. This would create an expectation of some level of involvement. The control package comprised 34 messages, delivered over 4 weeks. The messages addressed four topics – diet, physical activity, sexual health and mental health – with each topic lasting 1 week. The messages did not include any components of behaviour change theories, nor did they encourage behaviour change. It was, however, comparable to the intervention package in the duration and number of texts, the use of questions to elicit responses, the provision of health information and the frequent use of humour. Previous reviews have shown that in brief alcohol interventions the control group commonly receives little attention. 9,10

Focus group comments on text messages

The design of the message content was assessed by members of the target population (11 disadvantaged men aged 21–55 years) in the focus groups. There was general support for both the acceptability and feasibility of a text messaging intervention. However, there was some scepticism and uncertainty as to its likely effect on substantive changes in drinking behaviours. Despite this there was broad agreement that a text would almost certainly always be read and that at the very least it would prompt a re-evaluation of drinking intentions.

What it might do, it would certainly make you think. It would certainly, it might be one little trigger and it might stop you there rather than going that little bit more.

Simon, aged 27 years

This suggested that a text might nudge the individual in the direction of behaviour change.

A lot of people are weak-willed so obviously they cannot do it on their own so they need that support there to help them to take the first step.

Brian, aged 29 years

Although nudging might be acceptable, urging behaviour change would not.

I always felt that nobody could dictate to you . . .  I mean I live my life the way I see fit and I wouldn’t tell anybody else what way they should live, that's just the way I am.

Harry, aged 50 years

Interactivity of texting (i.e. requesting a participant to text back) was seen as generally plausible.

Just texting back wouldn’t put you out in any way, you know?

Tony, aged 28 years

However, there were indications that some texts might be ignored if they appeared to be from commercial companies or if the timing was inappropriate. The issue of frequency and timing was therefore explored in more depth. All focus groups appeared to concur that 2–4 texts per week maximum was appropriate. Suggestions for timing highlighted the effect of drinking on the individual's ability to make judgements and therefore the potential importance of both pre-drinking prompts and early-evening reminders.

I’d need a text when I’m sober so that it’s more of a thought-provoking text to say, well you know what, maybe tonight, I’ll not go, I’ll do something else. Because I think once I’m in the pub and I’m a round in, it’ll take a hell of a lot more than text messages, if I’m in the mood, to tell me to go home.

Simon, aged 27 years

Once on a Friday, a Friday afternoon. Because on a Friday you know what I mean, a lot of people go out drinking. And then Monday mornings, to remind them because they did get drunk all over the weekend. And then they’ve got an incentive for the next week to try and keep them off it.

Ben, aged 38 years

Given participants' indication that the receipt of between two and four texts per week might be acceptable, the question of how to sustain engagement with the texts was explored. Central to a tactic of sustained engagement was the use of humour. However, humour was again perceived by participants to potentially lead to more indirect or ‘diluted’ messages, therefore resulting in reduced effectiveness. Thus, humour was used sparingly and was avoided in the texts promoting behaviour change.

Do you want people to focus on the joke or do you want people to focus on the message? If you send a cracking joke with that text then it might take the focus off the actual text in the first place. Whereas you’d think that was a brilliant joke and you’d forget where it came from.

Simon, aged 27 years

One focus group was held with three women from areas of high deprivation. This was to give a different (but relevant) perspective on men's reasons for drinking, awareness of harms and likelihood of responding to the intervention. Women who participated were partners of men who met the entry criteria.

The women confirmed that their partners were regular heavy drinkers who drank mainly at home.

Well he drinks every weekend, for the weekend.

Claire, aged 19 years

They suggested that their partners drank because of boredom or to relax, but also because it is part of the culture.

Probably because they have been brought up round alcohol.

Janine, aged 19 years

The women were shown the text messages and asked how they thought their partners would respond to them. However, all of the women were more likely to give a personal reaction to the messages, and discussed what effect the texts would have on their own drinking. For some of the messages they said that they did not know how a man would respond. However, for a message which suggested that participants might try to reduce their drinking, the women thought it could be counterproductive because men don't like to be told.

Yes because a guy was, like a guy that likes his drink and goes out with his mates and if they were to read that they’d be like oh right, go and get a drink.

Mairi, aged 38 years

However, they conceded that some of the messages were likely to make some men think about their drinking.

It can hit home with some but not all.

Claire, aged 19 years

The women also indicated that they would be supportive if their partners were taking part in the study. In response to being shown the text message ‘Let friends and family know you are trying to cut down, tell them about this study and they may give you their support’, they said:

I would give my man support.

Janine, aged 37 years

I like it.

Claire, aged 19 years

Incorporation of effective behaviour change techniques

The messages were continually mapped onto 26 behaviour change techniques described in a recent review by Abraham and Michie15 on theory-based techniques used in interventions. This helped to identify any gaps in the strategies used, enabling new messages to be developed to strengthen the intervention. The final intervention included 15 behaviour change techniques from the list of 26. For example, the technique of gaining social support for behaviour change was used in the text: ‘let friends & family know if you are trying to cut down. Tell them about this study & they may give U their support’. Some texts incorporated more than one technique. The text ‘drinking too much can spoil a good night out & make U regret the things U did! Self control = more fun!’ provided information on consequences, prompted self-monitoring of behaviour and provided motivation for change.

Techniques to promote recruitment

Several techniques have been shown to increase recruitment rates. As non-contact makes at least as large a contribution to failure to recruit as does refusal to participate,105,106 both non-contact and refusal were addressed. Systematic reviews show that repeated attempts at contact and monetary incentives increase recruitment to research studies. 45,107 Strategies which have been found to be effective in general population groups31,32,44,107–110 are shown in Box 2. Similar strategies have been identified for recruiting hard-to-reach and minority groups, although particular emphasis is given to culturally sensitive study materials, multiple recruitment strategies and incentives. 111–115

Participants

Men aged 25–44 years living in areas of high deprivation were recruited. Deprivation was measured using the SIMD,46 which is similar to the English Index of Multiple Deprivation. 116

Inclusion/exclusion criteria

Men were included in the study if they had two or more episodes of heavy drinking (≥ 8 units in a single session) in the preceding month. Men currently attending care at an alcohol problem service and men who would not be contactable by mobile telephone for any part of the intervention and follow-up period were excluded.

Recruitment methods

The invitation letter, participant information leaflet and consent form are presented in Appendix 2. The screening questionnaire is in Appendix 3.

Initial screening and informed consent

Individuals identified by the recruitment strategies were screened by a telephone call from a researcher to establish current drinking levels. Those who reported binge drinking (≥ 8 units in a single session) at least twice in the previous 30 days were identified as potential participants. The details on the participant information leaflet were explained, such as their right to withdraw from the study at any time and the confidentiality of the data. Verbal consent was sought after potential participants confirmed that they had understood the contents of the information leaflet. Those who agreed to participate were sent a text message which asked them to reply to the message if they wanted to take part in the study. This meant that potential participants had to indicate their consent to participate by taking the positive action of responding to a text message. During the screening interview a consent form was completed by the research fellow. When the consent text was received, the date and time of obtaining consent was recorded and the form was signed by the research fellow. The consenting text was retained as proof of consent.

Recruitment

Recruitment began on 17 March 2011 and was completed on 12 June 2011. A total of 67 men were recruited, exceeding the target of 60. The over-recruitment occurred because of the yield from the final GP. As the response rate could not be predicted, letters of invitation were sent to all 120 men randomly selected from the GP list at that practice. Recruitment could have been stopped when the intended target of 60 participants was achieved, but it seemed unwise, and possibly unethical, to write to men about a study then subsequently fail to invite them to participate.

Yield from recruitment through primary care

Identifying men living in areas of deprivation from practice databases proved straightforward. A random sample was taken of men on the practice lists who were in the appropriate age and deprivation categories. The sample taken allowed for anticipated loss due to failure to contact, ineligibility (do not binge drink frequently) and refusal. GPs screened these samples to exclude candidates because of concerns about health or family problems. The GPs noted that screening the lists of men was difficult because few of the men attended their doctor regularly. Almost all the men (89%) had telephone numbers, either landline or mobile, in their GP records and few (3%) were excluded by their GP (Table 4).

As expected, some of the telephone numbers were invalid (Table 5); in fact, 25% of numbers tested were invalid. As up to six attempts were made to contact the men (covering daytime, evenings and weekends) it was expected that most men would answer the telephone. In the event, 18% of those with valid telephone numbers did not answer the telephone. Of those contacted, 31% refused to participate and a further 40% were found to be ineligible because they did not binge drink regularly. As a result, 29% of those contacted were recruited.

Lessons from recruitment through primary care

Recruitment through primary care is subject to losses from failure to contact (missing or incorrect telephone numbers) or refusal to take part. Ineligibility, because of low frequency of binge drinking, was a major reason for failure to recruit. Some men appeared concerned that the approach might be part of a scam to steal money. This was more marked when first-approach telephone calls came from an institutional 0845 telephone number. Use of a dedicated study mobile telephone number overcame this difficulty. As participants are randomised to treatment group, losses to recruitment will not affect internal validity of the study. Trials recruiting through this route should contact substantially more individuals than required to allow for these losses.

Yield from recruitment through respondent-driven sampling

In total, 30 men were recruited over a 5-week period. The sample of 30 men comprised 12 who did not nominate any friends and seven who nominated 11 friends in total. All of the nominated friends were recruited to the study. The venues through which men were recruited are shown in Table 6 (nominees have been allocated to the venue on the nominator). Multiple locations were used to ensure recruitment of individuals from different social networks. Recruitment took place during the day, in the evening and at the weekend.

Lessons from the respondent-driven sampling

Other lessons learned

Several observations were made during the conduct of the telephone calls. As these were unexpected findings, data recording procedures had not been put in place to record them. Thus, they could not be quantified.

1. Some men found the information given about the study did not fully explain what would be involved. Although further information was given during recruitment, it is possible that some men may not have asked for clarification, and instead refused to participate. Forming a rapport at the first telephone call and actively exploring concerns about participation can prevent this loss of participants.

2. People who drink a lot may be unwilling to disclose this to a stranger. They would thus be classed as not meeting the entry criteria. Establishing rapport, emphasising the confidential nature of the data and stressing the benefits of the research will minimise this problem.

Randomisation and blinding

After obtaining informed consent, participants were randomised to receive intervention or control messages by a three-way collaboration between the Schools of Medicine and Computing at the University of Dundee and the University of Glasgow Clinical Trials Unit. The processes were repeatedly tested in isolation then in combination. Handshaking between the Glasgow and Dundee computer systems required careful attention.

A web-based randomisation strategy was provided by the University of Glasgow Clinical Trials Unit. After consent had been obtained by the research fellow in the School of Medicine, Dundee, participants were allocated a unique study ID number. This, together with method of recruitment (GP or RDS), was entered into the randomisation website. Randomisation, allocation ratio 1 : 1, was stratified by recruitment strategy (GP or RDS) and was restricted using a block size of four.

The research fellow at the Medical School entered key participant information (ID, date of recruitment and participant's preferred name) into a website provided by the School of Computing at the University of Dundee. The Clinical Trials Unit sent the randomisation codes, with participant ID, directly to the School of Computing which then combined the randomisation code data with the participant information. The School of Computing managed the computerised delivery of the intervention. It was thus able to send a predetermined sequence of text messages (intervention or control) which were tailored to individual participants. The date of recruitment was used to start messages on the first Monday following recruitment. Thus, the School of Medicine research fellow who recruited participants and conducted baseline and follow-up interviews was not involved in the randomisation or the delivery of the intervention. Furthermore, the research team in the School of Medicine remained blind to treatment status until after the analysis of the primary and secondary outcomes.

Baseline interview

The baseline interview was conducted by telephone at a time suitable for the participants prior to the delivery of the first of the text messages. Interviews typically took 15–20 minutes, although occasionally longer. The interview largely comprised closed questions. A blank pro forma was completed during the interview and checked for completeness after the interview.

Baseline questionnaire (see Appendix 4)

Data were collected on age, address (to derive an area-based measure of deprivation), employment status and educational attainment. Questions on alcohol consumption were taken from the US Behavioral Risk Factor Surveillance System. 120 This enabled total consumption and frequency of binge drinking to be measured. Alcohol consumption was measured over the 30 days prior to interview to capture patterns of drinking which could vary from week to week. In addition, the frequency of drinking substantially in excess of the conventional binge drinking level (i.e. ≥ 16 units in a session) was recorded. The Fast Alcohol Screening Test (FAST)121 was used to determine hazardous drinking because it is short and thus suitable for telephone use. Questions on refusal skills were taken from the Drinking Refusal Self-efficacy Questionnaire. 122 The Readiness to Change Questionnaire123 was used to measure the stage of intention to reduce consumption. A separate question was also added on intentions to reduce drinking. Questions were also asked on knowledge of the harms of alcohol, the definition of binge drinking, the benefits of moderate drinking and whether or not current drinking was perceived to be harmful. The questions on harms were not restricted to health, but were left open so that any type of harm could be mentioned. The question on the benefits of moderated drinking was similarly unrestricted. The questionnaire was piloted and modifications were made to several questions.

Reported alcohol consumption (pints, bottles, etc.) was converted to units of alcohol. The free text answers to two questions (harms of drinking and benefits of moderated drinking) were listed and coded as short term (e.g. hangover, violence and accidents) and long term (e.g. cirrhosis, family break-up and addiction).

Statistical methods

Descriptive statistics were used to explore the characteristics of the intervention and control groups at baseline. Blinding was preserved until outcome data were collected and analysed. Until blinding was broken treatment groups were assigned arbitrary codes 1 and 2 by the School of Computing. The coding key was concealed until after the analyses. As part of the assessment of the two recruitment strategies a comparison was made of the participants recruited from primary care and through RDS. The chi-squared test was used for categorical data and the t-test for continuous data to test whether or not the men in the two recruitment strategies differed.

Impact of the strategies

The retention rate in the trial was 96% (64/67). Three men from the intervention group were lost to follow-up, of whom two were recruited by RDS. Two were aged between 25 and 29 years and were single, while the third was aged > 40 years and was married. Two of the men were in employment and both had vocational training after leaving school. The men lost to follow-up drank infrequently but they all drank in excess of 16 units in each drinking session. These men were in pre-contemplation on the Readiness to Change Questionnaire and two reported that they had no plans to cut down on their drinking.

The retention rate in this study is substantially higher than most studies of brief alcohol interventions9 and most studies of community-based interventions. 134 The result is more remarkable because it was achieved with disadvantaged men, a group recognised to be difficult to retain in research studies.

It was not possible to identify which component(s) of the recruitment strategy contributed to this success. However, there is clear evidence that many of the men valued the experience of taking part in the study. Following the final text message to the participants, which thanked the participants for taking part, some men spontaneously texted to thank the researcher. Their comments show how much they enjoyed participating, confirming the high level of engagement identified in the process evaluation:

No worries my pleasure.

Well really enjoyed some of the interesting facts so ur welcome Donald.

Thank for all the texts some were really funny good luck with your study thanks again look forward to chatting in a couple of months.

It was fun.speak soon bud.

Okay its been gud taking part in ur study!and i wul hear from you in 2 months then ok spk to then k from <<NAME>>!

Statistical methods

The protocol stated that the study was not powered to detect the effects of the intervention and formal hypothesis testing was not appropriate. It specified that only descriptive analyses would be undertaken. The tabulations are presented primarily to demonstrate that the outcomes can be readily measured and the data for the full trial would be in the appropriate form for analysis.

Changes in drinking

Alcohol consumption was measured over a 30-day period. Compared with baseline, men in the intervention group reduced their frequency of binge drinking (≥ 8 units in a session) slightly more than men in the control group (Table 17). A similar greater reduction in the frequency of heavy binge drinking (≥ 16 units in a session) was also seen in the intervention group compared with the control group. These changes were matched by a greater increase in the number of days of moderate drinking in the intervention group. The total amount of alcohol consumed by the intervention and control groups fell by similar amounts.

Intentions to reduce consumption and beliefs about harms

Slightly more men in the intervention group moved from not having a plan to cut down their drinking to having such a plan (Table 18). A similar result was seen in the Readiness to Change Questionnaire, in which more men in the intervention group moved to being in the action stage of changing their drinking.

Knowledge about drinking and drinking refusal self-efficacy

There was a marked increase in knowledge of the definition of binge drinking level in both intervention and control groups (Table 19). This could have occurred because the baseline questionnaire explicitly stated that binge drinking was 8 units in a session (the question investigated whether or not the men thought that this level of drinking could be harmful). In contrast to knowledge, awareness that drinking 8 units of alcohol in a session was harmful remained unchanged. This suggests that the intervention did not address this issue adequately. There was a large fall in the number of men in the intervention group who thought the benefits of their drinking outweighed its harms. The control group increased slightly on this measure.

Knowledge about the harms of heavy drinking and the benefits of moderate drinking were unchanged (Table 20). This most probably reflects the very high levels of knowledge at baseline. Drinking refusal self-efficacy also remained largely unchanged (Table 21).

Potential for contamination

An unexpected finding was the extent to which study participants discussed the text messages with friends and family members. Almost all participants (95%) mentioned the study to at least one person and 42% discussed it with more than five people. It is possible that socially marginalised groups have close social networks that facilitate such sharing. This raises the possibility that, in an individually randomised trial, the control group could be contaminated by intervention group messages. This observation was made as part of the extensive process evaluation conducted within the study: in this case sharing was a measure of engagement.

Research question 1: fidelity of the delivery of the intervention

The intervention comprised a combination of SMS messages (text messages) and MMS messages. The delivery was administered by a computer program at the Computing Department at the University of Dundee. SMS messages can be tracked to determine whether or not they were delivered to the telephone (it is not possible to track MMS messages). When SMS messages were not delivered to the telephone immediately, the computer program continued to try to send the message for 24 hours. If the message could not be delivered during this period, this was recorded as a delivery failure and the programme would then send the next message in the sequence.

Data captured on the delivery status of the SMS messages were recorded as: delivered (the telephone had reception and was switched on); undelivered (the telephone was switched off or it had no signal for 24 hours); or no status returned. The program did not record whether or not messages delivered to the telephones were opened. The proportion of SMS messages delivered to participants in the intervention and control groups was monitored as a measure of fidelity of the delivery of the intervention.

Research question 2: responses to text messages and characteristics of responders

Both the intervention and control packages included questions asked in text messages. The primary purpose of these questions was to promote engagement and to maximise retention of participants in the study. Responses to the text messages were received and collated by the Computing Department at the University of Dundee. The anonymised messages were screened daily by a member of the research team who was not involved in recruiting the participants or delivering the intervention. This ensured that any specific requests (e.g. to withdraw from the study, to find out where to get help for an alcohol problem, or a change in telephone number) could be dealt with.

On completion of the study, the collated data were analysed to gauge engagement and to examine the type of the men who responded by demographic characteristics and drinking history. The FAST121 and the Readiness to Change Questionnaire123 were used to measure hazardous drinking and attitudes to drinking behaviour. Intervention and control data were analysed separately. Study participants were categorised as high responders or low responders. High responders in the intervention group were men who replied to seven or more of the nine questions asked, whereas high responders in the control group were those who responded to at least three of the four questions asked.

Research question 3: content analysis of the responses received

Participants in the intervention group received a series of 36 SMS and MMS messages. These incorporated behaviour change techniques using social cognition models93 and MI124 which were organised by the stages of the TTM of behaviour change. 165 Nine of the 36 messages requested a response to a specific question. The questions were carefully crafted to reinforce specific components of the intervention.

Control group participants received 34 SMS and MMS messages on four health topics: healthy eating, physical activity, sexual health and mental health. One message each week asked a multiple-choice question on the topic of the week. The control package was designed to provide information on each topic and to be interesting and funny as a means of keeping the men engaged. The content of the messages did not incorporate any behaviour change techniques.

Responses to the messages confirmed that the participants had: opened and read the message; understood the question; reflected on the content/context of the question; and given an appropriate and considered response. Analysis of content of the messages from the intervention group participants permitted an assessment of engagement with the study and with the psychological constructs of the intervention. Responses to the questions gave an indication of engagement with behavioural antecedents to reduced drinking:

• recognition of reasons for drinking

• awareness of the harms of heavy drinking

• perceived benefits of drinking less

• subjective norms (perception of significant others' beliefs about their drinking)

• control beliefs (beliefs about factors that facilitate drinking less or impede drinking less)

• perceived behavioural control (perceived ease or difficulty in drinking less)

• behavioural intentions.

In addition, responses to the questions were used to determine whether or not the messages were understood and how they may be modified and improved for the full trial.

Research question 4: acceptability and impact of the intervention

Following the outcome assessment questionnaire which was completed by telephone interview, participants were asked a further 10 questions about their experience in taking part in the study. The questionnaire comprised both closed and open questions on the acceptability of the study, whether or not they had encountered any problems with the delivery of the intervention, and also if they had gained anything from taking part. Open questions encouraged men to reflect on what they may have learned, whether or not the intervention encouraged them to think about their health, whether or not they felt the need to improve their own health and any changes they were thinking about making or had made. This was designed to give insight into ways in which the intervention and control packages and their delivery could be improved.

Research question 1: fidelity of the delivery of the intervention

The intervention package included 19 SMS messages while the control package included 14 messages. The MMS messages (17 for the intervention group and 20 for the control group) could not be tracked. A total of 1108 SMS messages were sent to the 67 participants during the intervention period. Of these, 1053 messages (95%) were delivered to the participants' telephones. Of the remaining 55 messages, 45 were recorded as undelivered (the telephone was switched off or it had no signal for 24 hours); no delivery status was recorded for the remaining 10 messages. Only 11 men failed to receive all of the messages, eight from the intervention group and three control group participants. The number of failed messages among these 11 participants ranged from 1 to 13, with a median five messages missed.

Research question 2: responses to text messages and characteristics of responders

Intervention group

Thirty of the 34 study participants (88%) in the intervention group responded to the text messages that asked questions (Figure 2). More than half (18 men) replied to seven or more of the nine questions, with two replying to all nine questions and a further nine men answering eight questions. Of the four men who did not respond to any of the questions, two were also lost to follow-up.

FIGURE 2.

Intervention group: participants' text message responses to the nine questions.

More than 82% of men in the intervention group responded to the first question (Figure 3). For the remaining eight questions, an average of 20 men responded. Overall, there was little evidence of attenuation during the intervention period. In addition to replying to the questions posed, many of the men commented on other text messages. Nineteen of the 27 messages which did not request a response received at least one reply (see Figure 3). Responses to these messages simply acknowledged that the message was delivered, expressed empathy with the message, or responded to the humour in the message.

FIGURE 3.

Intervention group: total number of responses to text messages.

Characteristics of the men in the intervention group who responded

A comparison of high and low responders was made to explore the factors which influenced engagement with the study. High responders [those who responded to seven or more of the questions posed (n = 17)] were more likely to be married or living with a partner (71% of high responders vs 29% of low responders) and were more likely to be in employment (77% vs 36%). More of the high responders were recruited from GPs than through RDS (71% vs 43%). The high responders were more likely to report that they had fewer (two or less) heavy binge drinking days (≥ 16 units in one session) in the previous 30 days (65% vs 43%). However, more of the high responders were at the pre-contemplation stage on the Readiness to Change Questionnaire (77% vs 57%). 123 Factors that did not influence the frequency of responding included age, educational attainment, level of deprivation, frequency of binge drinking and FAST score. 121

Control group

Thirty-one of the 33 participants (94%) from the control group responded to the text message questions (Figure 4). One-third of the men answered all four questions and another third answered three of the four.

FIGURE 4.

Control group: participants' text message responses to the four questions.

Fourteen of the text messages that did not seek a response elicited comments from participants (Figure 5). The majority of comments on these texts were in response to humorous messages. More men answered the questions during the second half of the study, and 100% of the control group remained in the study at follow-up.

FIGURE 5.

Control group: total number of responses to texts.

Characteristics of the men in the control group who responded

Comparing high and low responders (three or four responses vs two or fewer) showed that, like the intervention group, high responders were more likely to be married or living with a partner (73% vs 46%) and were more likely to be in employment (82% vs 63%). Fewer of the high responders (n = 22) were in the younger age group (27% vs 64%). More of the high responders were recruited from GPs (68% vs 27%). High responders were less likely to report binge drinking days (≥ 8 units in one session) on more than three occasions in the previous 30 days (50% vs 73%). More of the high responders were at the pre-contemplation stage on the Readiness to Change Questionnaire (64% vs 36%). Factors that did not influence the frequency of responding included educational attainment, level of deprivation, frequency of heavy binge drinking (≥ 16 units in one session) and FAST score.

Research question 3: content of the responses received

Research question 4: follow-up questionnaire

The follow-up questionnaire was completed by telephone interview 3 months after recruitment to the study. Of the 67 men recruited, 64 (96%) completed the study. The three men lost to follow-up belonged to the intervention group. This section describes reported access to the text messages and reported acceptability and impact of the intervention. The results of the impact of the intervention on the primary and secondary outcome measures are given in Chapter 9.

Characteristics of participants

The Phase 3 participants were representative of the whole study population. Five men participated from each of the four age groupings from 25 to 44 years. Half of the men were married and 9 of the 20 men were in employment. Thirteen men had received no education after leaving school and half of them lived in the most socioeconomically disadvantaged areas of the city. Twelve men were in the pre-contemplation stage on the Readiness to Change Questionnaire,123 although 13 indicated at baseline that they had at least thought about cutting down on their drinking. Almost all (90%) of the men were drinking hazardously at baseline (i.e. had a positive FAST). 121

Factors influencing the decision to take part in the study

Curiosity and self-interest were most commonly given as the main reasons for taking part in the study (e.g. ‘Just to see what it was. I was curious’). Others were interested because the study was about alcohol. One man said that he thought the study would help to ‘try to take care of my alcohol problem’, one reported that he took part because he was in the process of trying to stop drinking, and another said he ‘was thinking about it anyway’. However, it appeared that alcohol as a topic had appeal even when the participant was not considering cutting down: ‘I thought it would be interesting topic. It [alcohol] was medium to a big part of my life’.

Several men took an altruistic approach. One man felt that it was ‘Important that people give their views and if it helps you [the researcher]’, whereas another said it would be ‘Good experience to help out’. Some men who were recruited through RDS appeared to want to please the person who had nominated them: ‘Mentioned by a friend and thought I would see what it was about’ or simply ‘My friend asked me’.

One man, recruited by RDS, appreciated being asked, although he clearly had apprehensions. He said that he wanted to take part ‘because nobody offered me these type of questions before’. He was encouraged because the study was conducted by telephone: ‘I didn't have to face the person’. He confessed he would be concerned about ‘a clash of personality’.

Six of the 20 men stated that they had doubts and concerns about taking part when asked directly. These were often general uncertainties: ‘Didn't know what was letting myself into, what was in store’, although these apprehensions were short-lived with one man saying they were ‘not borne out by the study’. Two men were concerned that they were being judged as alcoholics. One was ‘Afraid about what you were going be told. Would I get classed as an alcoholic?’, whereas another said ‘I was worried it was like the AA’. The participant information pack helped to alleviate worries: ‘Got the letter and read it and that helped a lot’. Four participants who were recruited by friends (RDS) thought that the decision to take part could have been easier if they were given more information by text message, e-mail or by a trustworthy person.

Nineteen of the 20 men said that at the end of the study they would be willing to nominate a friend to take part. The most common reason given was that the men felt a benefit from taking part and that the study raised awareness on health issues: ‘Good idea to improve the health of the community’. Although men in the control group did not receive any messages on alcohol, similar numbers from the intervention and control groups said that they would nominate friends to raise awareness on alcohol and help them with alcohol-related problems:

make them thinks about their drinking and what it's doing to them.

Cause I have got a few friends in same situation as me. And they could do with the help as well.

One man from each group (intervention and control) said they would nominate someone for entertainment value: ‘Such a good study, and you learn a lot from it! The text messages always fun to receive as well’. Credibility of the source of the messages was important. One man said he would nominate a friend ‘because you are from the university and he will know you are trying to help’. One man was dubious about whether or not his friends would take part if nominated, although he believed the study would benefit them: ‘a few friends that I think would benefit but they wouldn't take part’. Only one man said that he would nominate a friend for financial benefit.

Likes and dislikes

When asked specifically what they liked about the study, most participants commented on the appeal and acceptability of the overall approach. The comments indicated that both the method of delivery and the content of the messages were appropriate for the target group. One man summarised this succinctly: ‘Liked the style and the way it was delivered. Up to date, not letters. Felt direct’. Another commented that the study ‘Made you think about it in a non-serious way. More relaxed about it. If it was too serious, I would be less willing to think about’. Another man concurred saying that it ‘Didn't feel like it was pointing the finger’. The humour also appealed to the men: ‘I thought it was a good laugh. It cheered me up when I got it’.

Two men from the intervention group commented on the timing of the delivery of the text messages: ‘The randomness of the texts was good. They came in at times that stopped me from drinking. Seven out of 10 texts made me change my mind from drinking’.

Men from the control group also reported on the usefulness of the text messages, although they were given general health promotion messages only: ‘Couple of messages that opened your eyes to things that you didn't know before’ and ‘No pressure. Some of them were interesting. The questions were good, gave me something to do’.

The participants were hesitant in divulging details of anything they didn't like about the study. One participant said ‘The initial telephone call. I felt you were maybe trying to accuse me of being an alcoholic. Maybe trying to trip me up’. However, his apprehensions were fully resolved during the initial telephone call.

Opportunities for improvement

Participants were asked to consider how the intervention and control messages could be improved. The majority of men were satisfied, with some commenting that they enjoyed the texts. One man commented that ‘Anybody could have understood the messages even if you were dyslexic’. Only one man commented on the timing of the message delivery. He reported that he did not like receiving messages when he was out drinking. However, on reflection he decided ‘in long run [the intervention] has had a good effect, but at the time not good, but now think maybe it was good I got them’.

Most comments were suggestions on how to improve the images. The images were clearly important in reinforcing the text messages. One participant noted that the ‘ones with the pictures made me think more’, whereas another man said that the ‘ones with pictures – remembered better’ and suggested it maybe better to ‘put them all with pictures’. One man suggested introducing animation to the images and another wanted the ‘Cartoon pictures more life like. . . Real life’. He thought that he did not associate the images with himself if they were in cartoon format. One participant suggested the images could contain adult humour or be ‘a bit cheekier’.

Influences on drinking patterns

The majority of men from both groups reported that taking part in this part of the study made them think about changing their drinking. When asked if they could remember what made them want to change, the most common response was for family and health reasons:

My daughter is only 4½. Want to be with her as long as possible.

To save my health for my family.

One of the texts came through and I showed it to my daughter, and she said ‘you are going to have to do something about your drinking Dad’.

Men in the intervention group tended to give general answers about the effect of the intervention package and reasons for wanting to change:

The whole survey altogether.

Thinking about it, it was making me actively think about it. Text messages were making me think about it. It has been a good thing.

Reading the texts and make you think.

However, men in the control group who had not received the intervention text messages also reported that the study made them think about changing their drinking. They also recalled information given in the baseline questionnaire:

It was the binge drinking units in the questionnaire at the start.

Not to binge drink. Realising 4 pints is binge drinking.

Something I was doing anyway, but binge drinking of 4 made me think again.

Reading about facts. Did not think 4 pints is binge drinking.

Moving on from desire to change, the men were asked ‘Do you think you did change in any way?’

Several men from the intervention group reported that they had changed:

Drunk less, only one binge a month.

Yes, thought more about it and have cut back some weeks certainly.

Yes. Doing more stuff. When I went out drank juice, went to gym more, took my daughter out more.

A bit, but in the process of changing.

Yes, definitely, drink a lot less.

However, men in the control group also reported actual changes:

Took more interest in walking more. Don’t drink as much. Don’t down 3 to 4 pints each time.

Yes, bit more aware of drinking.

Yes – during my time of study had more alcohol in the fridge but was not going to the fridge. Was gradually drinking slower.

Yeah, more conscious of what I am drinking.

Two men, both from the control group, realised that they had not changed, but reported that this was due to family problems:

Not sure, as had a blow out as had problems with girlfriend.

No because a bad time with family, broke with missus.

Barriers to reducing drinking

Following discussions around the impact of the study, the men were asked to consider what the barriers would be to anyone who wanted to reduce their drinking. A few men from each group were unable to identify any barriers: ‘If they are going to do it they are going to do it’. One man thought it was about ‘Being able to control themselves, once you go past the limit its difficult to control yourself’. Overcoming addiction was highlighted by several men, some of whom felt lack of willpower was the barrier:

If you’re addicted, it’s about willpower.

Too hard, not got the will-power. It’s psychological.

Some men realised that drinking was a habit and the barrier is ‘Changing their habit, it's a bad habit. If you are in a rut, it is trying to find something to do. Fill in your time better’. Others identified peer pressure, unemployment, boredom and potential barriers. One man thought the main barriers were ‘Availability and price, supermarket cheap vodka, cheap beer’.

In an attempt to identify ways of improving and enhancing the impact of the intervention, participants were then asked if they could think of anything that would help people to cut down.

Two men felt it was entirely up to the individual and the answer was about self-control: ‘You have to make your mind up yourself’.

Six men felt that having support, both from family members and from a doctor would help. Others had thought of ways to reduce the amount consumed in sessions. One man identified two strategies: ‘Count up how many you would normally have and then reduce 1 or 2 pints a time, or keep the bank card at home’. Others proposed strategies to avoid drinking situations: ‘Getting out and doing more, and not sitting in the house. Going out for walks, to clear your head’. Another was aware that being employed was one of the best ways to reduce: ‘Something that doesn't stress people out. Having a job helps people cut down’.

One man proposed a complicated strategy to reduce gradually in order to avoid withdrawal problems: ‘Try to get them to drink half as much! Even ¾ as much, to stop them rattling. Then ½ for 4 days. Then ¼ lager for 2 weeks. Then few tins of lager. If they come straight down they can have a heart attack or die on their own puke’.

Some men reported that this study had helped them and had the potential to help other people:

The initial survey. I thought when I came off the telephone – I have a bit of a problem. The text made you think twice about drinking. Not all but some of them.

Show them the messages that might help them. It helped me and it helped my friend as well because I showed him the messages and pictures and he used to drink a lot, now he has calmed down. I saved the pictures and went round and showed him.

The final question asked of participants was whether or not the gift vouchers (£10 on completion of the baseline questionnaire, £20 during the intervention period and £10 each for the follow-up questionnaire and the in-depth interview) encouraged them to stay in the study. Two-thirds of the men said that it did. Some reported how they used them, for example ‘bought kids toys’ or ‘saved them up and bought some aftershave’. For some the vouchers were seen as a ‘a little reward, little bonus’. The remainder of the men said they were not influenced by the vouchers: ‘I enjoyed the texts. The vouchers was just a bonus’ and ‘Would have done it anyway’.

Focus group analysis

1. Explanations for current drinking patterns and their change over time appear rooted in shifts in three interacting conceptual areas: private purpose (the individual's personal reasons for drinking), social roles (expectations, duties and sanctions on drinking) and concrete experience (of the adverse effects of excess drinking).

2. The set of social expectations stem from recognition of the person's wider social roles and responsibilities (employee, husband/partner, parent) and abilities (self-discipline/control, ability to tolerate alcohol, judge limits and resist social pressure).

3. Drinking motives had significantly changed from when the men were younger. This stemmed from a shift in the private purpose and social roles facilitated by alcohol use. It was accompanied by a shift from ‘freedom to’ enjoy the pleasures of alcohol to ‘freedom from’ life stresses through the use of alcohol.

4. Consumption was influenced by obligations to a range of competing social roles including parent, partner and employee that had not been extant when younger. In addition, recognitions of these changes produced what might be termed a ‘mature drinker’ role with associated expectations.

5. The mature drinker was viewed as someone who can tolerate greater amounts of alcohol without becoming drunk, has greater self-discipline, is more likely to be able to resist social pressures to drink, and drinks as a means of reward, relaxation and release from life pressures.

6. Knowledge of the negative experiences of alcohol was detailed and widespread. However, reported changes in behaviour appeared rooted in concrete personal or vicarious experience of these issues rather than more abstract risk.

7. Peers and social networks influenced drinking in this group in complex and subtle ways. Although some men felt that their friends were more accepting of their decisions to slow their drinking down, other men still felt pressure from their peers to consume large amounts of alcohol. In the second context, the consumption of alcohol signified membership of the group and gave the men a sense of belonging.

8. Drinking refusal self-efficacy largely depended on whether the group was predominantly defined by its drinking behaviour or another organising factor. A brief intervention might therefore highlight that the men have a choice about the different social networks they are accessing, and that this choice will affect the amount of alcohol they consume and ultimately their health and well-being.

9. There was often a marked discrepancy between an individual's drinking habits and the intended aims of drinking. Thus, brief interventions could highlight the mismatch between being drunk, and success in socialising, working, ‘doing good turns’ and feeling good about oneself.

Recruitment

1. 10. The intended target of 60 men from disadvantaged areas was easily exceeded using two recruitment strategies: through GP lists and by RDS. The use of evidence-based techniques may have assisted the recruitment.

2. 11. Obtaining ethical consent from individuals recruited through GP posed a challenge because there was no face-to-face contact. This was overcome by obtaining consent by a confirmatory text message.

3. 12. Recruitment by RDS required prior fieldwork to establish suitable venues for recruitment. The study found that participants could be recruited if approached in familiar settings. For the full trial, venues such as post offices, training centres for the unemployed, pharmacies and communal areas in high-rise buildings could be used.

4. 13. Flexible recruitment strategies involving multiple attempts at contact at different times of the day and days of the week are essential.

5. 14. Some potential respondents were concerned that the initial approaches might be part of a scam to steal money. This was more marked when first approach telephone calls came from an institutional 0845 telephone number. Use of a dedicated study mobile telephone number overcame this difficulty.

Baseline characteristics

1. 15. The men in this study were socially disadvantaged whereas those recruited to previous studies on alcohol brief interventions were mostly well educated and in employment.

2. 16. Baseline interviews were successfully conducted by telephone. Data on alcohol consumption over a 30-day period, including total consumption and frequency of binge drinking, heavy binge drinking and alcohol-free days were obtained.

3. 17. Binge drinking was common, with 57% of men consuming ≥ 8 units of alcohol in a session at least three times per week. In addition, 25% of men drank at least 20 units in a session.

4. 18. Most men were drinking at a hazardous level (84% had a positive test score on the FAST screening questionnaire).

5. 19. Randomisation was successful and the intervention and control groups were balanced at baseline.

6. 20. Participants recruited by RDS were less well educated and more likely to be unemployed. These men may be marginalised in society to such an extent that they have become a hidden group.

7. 21. Men recruited through RDS were much more likely to be drinking hazardously. These men also frequently suffered episodes of memory loss following drinking sessions. Recruiting solely through GP would miss high-risk drinkers.

8. 22. Knowledge of the conventional definition of binge drinking was low, with most men guessing the level was much higher. There is an opportunity to incorporate education on binge drinking into the intervention.

9. 23. RSOD was common, with episodes of heavy binge drinking interspersed with many alcohol-free days. This pattern of drinking has not been previously described in this age group. This type of drinking could explain why disadvantaged men are at such high risk of alcohol-related harms, even although the total alcohol consumed is not high.

10. 24. Heavy binge drinking was common despite a high level of awareness of the harms of binge drinking. This discrepancy, using the techniques of MI, provides a lever for behaviour change.

Intervention design

1. 25. The content of the intervention text messages was derived from seven types of literature: alcohol brief interventions, text message interventions, two psychological models (the TPB and the TTM), MI, communication theory and reviews of specific behaviour change techniques.

2. 26. The literature reviews identified several issues to be resolved including style and tone of the texts, the specific behaviour change strategies to be included, and the sequence and frequency of the messages.

3. 27. A combination of SMS texts and MMS messages with images were used to deliver the intervention. The images provided colour and variety and were used to complement the text messages.

4. 28. Despite the restriction of SMS texts to a maximum of 160 characters, the components of behaviour change strategies were successfully presented in the messages.

5. 29. The user group representatives provided insight into drinking motives and behaviour which identified opportunities for behaviour change. They also helped ensure that the interventions were acceptable and the outcomes were relevant and measurable.

6. 30. Messages were tailored to the target group and the individual by embedding them in the language and the drinking culture of disadvantaged young men. The messages used popular texting terms and abbreviations. The participant's first or preferred name was used, particularly in the early text messages.

7. 31. The text messages emphasised the credibility of the source (University of Dundee), used the informal style and abbreviations of everyday text messages and made frequent use of humour.

8. 32. A variety of techniques were employed to increase message effectiveness: tailoring of messages; use of gain-framed texts; pairing of messages; inclusion of questions to promote interactivity.

9. 33. Images were designed to develop and extend the narrative and to make concrete the harms of alcohol.

10. 34. The messages were constructed to take advantage of the conventional pattern of heavy weekend drinking. Messages were designed to tap into three windows of opportunity: before weekend drinking, after a heavy drinking episode and mid-week sobriety.

11. 35. The initial set of messages were tested in focus groups and improvements made. They were then mapped against reviews of behaviour change techniques to ensure that relevant techniques were not overlooked.

12. 36. The control group received a similar number of texts, but these were intended to have no influence on drinking behaviour. The control texts addressed four health behaviours: diet, physical activity, sexual health and mental health.

Intervention delivery

1. 37. Delivery of the messages was computerised, and followed the same schedule for all men. Messages began on the Monday morning following recruitment and continued for 28 days. This enabled messages to be tailored to day of the week.

2. 38. The computerised system could identify receipt of SMS text messages and could collect responses from the participants. This enabled messages to be terminated for individuals who wished to withdraw from the study. In the event no-one asked to leave.

3. 39. The use of a computerised system for the automated delivery of the text messages means that large numbers of men could be targeted at low cost.

Retention

1. 40. Through the use of multiple evidence-based strategies embedded throughout the study, a retention rate of 96% was achieved with a difficult-to-retain group.

2. 41. Over 90% of men thought that participation in the study was informative and worthwhile. The text messages were very popular and many men would have liked more text messages.

3. 42. Three features of the messages – anticipation of the content of the next message, the varied time of sending of the messages and the frequent use of humour – may have contributed to the popularity of the study.

Process evaluation of the delivery and impact of the intervention

1. 43. Novel methods of process evaluation were employed in this study. These shed light on the fidelity of delivery of the intervention and on the impact of the components of the intervention. The novel methods complement and strengthen conventional process measures.

2. 44. The fidelity of delivery of the text messages can be successfully measured through the computer system which managed the sending of the messages. Overall, 95% of SMS text messages were delivered to the participants' telephones.

3. 45. The computer system also captured responses to text messages. Responses to text messages were common, particularly for texts which asked questions. However, many participants responded to other texts.

4. 46. Eighty-eight per cent of men in the intervention group responded to one or more text questions. Over half of the men replied to at least seven of the nine texts which asked questions. Frequency of responding did not vary by age, social deprivation or level of hazardous drinking, suggesting this approach is suitable for different types of drinkers.

5. 47. There was no evidence that the frequency of responding decreased over the duration of the intervention, suggesting that, once enlisted, engagement is maintained.

6. 48. The questions gave the men the opportunity to think about the components of the behaviour change strategy. The questions thus form an important element of the behaviour change strategy.

7. 49. Analysis of the content of the responses showed that the men gave considered and personal responses to the questions, indicating a high level of engagement with the texts.

8. 50. Analysis of specific questions identified which of the components of the causal chain to behaviour change was achieving the intended response. The effective components included: subjective norms, control beliefs, perceived behavioural control and behavioural intentions.

9. 51. The process evaluation provides strong evidence that the proposed full trial will be a technical success.

10. 52. Men in the control group also showed a high readiness to respond to text questions. These questions concerned other health behaviours: sexual health, mental health, physical activity and diet. This indicates that the text message questions can be successfully used in studies targeting other health behaviours.

11. 53. Given the highly informative nature of the text question responses, they should be a feature of feasibility studies of interventions delivered electronically.

12. 54. This type of process measure is unobtrusive and gives real-time feedback on the components of the intervention.

13. 55. As text message questions have the potential to increase the effectiveness of the intervention, they should be used for each of the key components of the behaviour change strategy.

14. 56. Two text messages were found to be inadequate; one was ambiguous and the other (a loss-framed message) received a poor response. These messages will be changed for the full trial.

15. 57. Almost all (95%) of the men told someone else about the study and 40% discussed it with more than five people. This could increase the impact of the intervention on social norms (gaining support from family and friends). It could also facilitate national roll-out of the intervention, promoting uptake in the general population. Through this mechanism the intervention could act to promote culture change by encouraging discussion of the benefits of more moderate drinking.

16. 58. The extent to which study participants discussed the text messages with friends and family members has an unexpected consequence for RDS. As this technique aims to recruit several individuals from close social networks, contamination of the control group could occur. Abandoning the community outreach recruitment strategy would seem unwise, since recruiting only through GP would exclude many high-risk drinkers. The solution is to use an alternative strategy, time–space sampling. This technique recruits individuals from multiple venues, but avoids recruiting groups of individuals from the same social network.

Outcome assessment

1. 59. The primary and secondary outcomes proposed for the full trial were successfully measured on all subjects who were followed up.

2. 60. More men in the intervention group reduced their frequency of binge drinking, and heavy binge drinking, than in the control group. There was also a greater increase in the number of moderate drinking days in the intervention group.

3. 61. More men in the intervention group increased intention to reduce their alcohol consumption, as measured by the Readiness to Change Questionnaire and a question specifically about intentions. These changes were accompanied by a fall in the number of men who thought the benefits of their drinking outweighed its harms.

4. 62. The success of the intervention most likely reflects four key design features.

   1. The use of a delivery medium, the mobile telephone, which is an attractive, valued means of communication by the target group. It gave the men control over when they read the messages and gave them time to reflect on them and respond to them if they chose (most men did respond).

   2. The consistent use of a friendly supportive style in which behaviour change strategies were interspersed with novelty and humour. The messages were of sufficient popularity to be shared widely with friends and family.

   3. The use of questions to encourage extended engagement with the behaviour change strategies. These questions elicited carefully thought-out, highly personal responses.

   4. The phrasing of text messages in the language of the target group, based on the focus groups conducted prior to and during intervention development.

5. 63. There was a high awareness of both the harms of alcohol and the benefits of moderate drinking in both intervention and control groups. This indicates that these items should not, as was proposed in the protocol, be used as secondary outcome measures.

6. 64. The feasibility study identified that drinking refusal self-efficacy was not influenced by the intervention. For the full trial the intervention will be improved by giving increased emphasis on self-efficacy.

Post-trial assessment

1. 65. The main reasons for taking part in the study were curiosity about the study, interest in the topic of alcohol and feeling valued.

2. 66. In the recruitment process, more emphasis could be placed on the importance of each individual to the research study. The potential to help others could also be stressed.

3. 67. Some men expressed initial concerns about participation, particularly being classed as an alcoholic and uncertainty about what the study would involve.

4. 68. The majority of men thought that the financial incentives promoted retention within the study.

5. 69. By the end of the study almost all the men said they had found the experience sufficiently worthwhile that they would recommend participation to their friends.

6. 70. The friendly style and the varied content, particularly the use of humour, were highly valued by the participants.

7. 71. Text messages with images were thought to have had more impact than text messages alone. Making images more realistic could increase their relevance to the participants.

8. 72. Men in the intervention group thought that the study increased intention to change drinking, through concerns about personal health and their families.

9. 73. Some men in the control group reported being very surprised by the statement in the baseline questionnaire that consumption of four pints constituted binge drinking. They may also have been influenced by baseline questions on the harms of alcohol and the benefits of moderated drinking. These questions should be omitted for the full trial.

10. 74. The control messages may also have influenced drinking intentions. This could be because the control messages were comparable to the intervention package in the duration and number of texts, the use of questions to elicit responses, the provision of health information and the frequent use of humour. Thus, for the full trial the number of control texts should be reduced, as should the amount of health information. This would make the control group messages more comparable to those used in conventional alcohol brief interventions.

Implications for other research studies

1. 75. Questions embedded in text messages provide a simple method of process evaluation for trials of behaviour change interventions delivered by electronic media. The questions should tap into key components of the behaviour change strategy, to assess the extent of engagement with each component. Rather than being intrusive, this method of process evaluation may promote engagement with the intervention and thus increase its effectiveness.

2. 76. Follow-up rates are likely to be higher if the intervention is inherently enjoyable. Behaviour change interventions should address the enjoyability of their intervention. The challenge is to make sure the intervention is not boring or ‘preachy’.

3. 77. The intervention and delivery method could easily be rolled out for use with other social groups and other adverse health behaviours. The responses to the control group text messages showed a high willingness to engage in improving mental health, sexual health, physical activity and diet.

Recruitment and retention

Recruitment was successful. It is recommended that GP recruitment together with a community outreach strategy be used in the full trial. RDS, by recruiting several individuals from close social networks, could lead to contamination of the control group. An alternative strategy, time–space sampling, could be used. Retention, at 96%, was very high and the existing strategies to promote retention should be maintained in the full trial.

Content and timing of messages

The messages were derived from an extensive review of several relevant fields of research. Components of behaviour change theories and techniques were successfully conveyed in short text messages and images. The content and timing of the messages was carefully planned to fit with the pattern of drinking of the target group. The high level of engagement with the messages indicates that the content was warmly received. The spontaneous ‘thank-you’ text messages at the end of the study support this conclusion. The post-trial evaluation showed that the frequency and timing of the messages was not only acceptable but also popular.

Influence on heavy drinking

The study was not powered to detect changes in drinking. However, the frequency of binge drinking reduced slightly more in the intervention group. In addition, there was a greater improvement in intentions to reduce drinking in the intervention group. These findings, together with the high level of engagement with the intervention, are compatible with the intervention being effective.

Summary

In summary, this study has successfully tested the feasibility of all aspects of a behaviour change intervention study which used text messages to deliver a brief alcohol intervention to disadvantaged men in early mid-life. The use of extensive process measures has shed light on many aspects of study design and conduct including the recruitment strategy and the design, delivery and impact of the intervention. This study design has demonstrated the potential to recruit, engage and modify drinking behaviour among disadvantaged young to middle-aged men. We recommend that a full trial of the intervention be carried out to assess the effectiveness of the intervention. We further recommend that a cost-effectiveness study be incorporated into the trial to determine whether or not the approach is truly a low-cost method of reaching large numbers of disadvantaged men.

Recruitment strategies

1. The evidence-based recruitment techniques should be retained for the full trial.

2. In the recruitment process, more emphasis could be placed on the importance of each individual to the research study. The potential to help others could also be stressed.

3. Given the differences in the types of drinkers recruited by the GP and community outreach strategies, it is recommended that both GP and community outreach recruitment strategies be used. With each method recruiting 50% of the intended sample, coverage of all types of drinkers will be achieved.

4. As RDS could give rise to contamination of the control group, an alternative outreach strategy, time–space sampling, should be employed. This recruits from areas which the target group is known to frequent and stresses the need for flexibility of setting, time of day and day of the week for recruitment. It requires initial fieldwork to identify a wide range of venues and suitable times for recruitment.

Randomisation

1. 5. As the randomisation method used in the feasibility study was successful and maintained blindness of the research team which collected and analysed baseline and outcome data, it should be used again.

2. 6. Randomisation should be stratified by recruitment method because of the difference in the types of men recruited by the two recruitment strategies. This will enable the analysis to determine whether or not the impact of the intervention differs between the two types of men.

Baseline questionnaire

1. 7. The question which gives information on the definition of binge drinking should be deleted as it could lead to contamination of the control group. This question will still be asked at follow-up.

2. 8. Fewer questions should be asked about the harms of alcohol, the benefits of moderated drinking and intentions about future drinking to ensure that the baseline questionnaire does not act as part of the intervention. This will be important for national roll-out, which would not involve the administration of a baseline questionnaire.

The intervention

1. 9. The use of the novel method of process evaluation identified a text message which was misunderstood and another which elicited a poor response. These will be modified.

2. 10. Information on the conventional level of binge drinking (≥ 8 units in a session) should be added to the intervention. The post-trial evaluation showed that the men were surprised to learn that as little as four pints constituted binge drinking.

3. 11. The analysis of the follow-up data revealed that there was insufficient improvement in self-efficacy to refuse a drink. Additional texts should be created to address this.

4. 12. Negative experience of alcohol should be presented in a more concrete manner to increase impact.

5. 13. More attention should be given to the discrepancy between drinking aims (relaxing, having fun and socialising) and the consequences of heavy drinking.

6. 14. The intervention should be extended to incorporate the HAPA, which seeks commitment to action and also promotes maintenance. Thus, new texts will be created to promote goal setting, to gain commitment to action, to overcome barriers to action and to promote maintenance of the reduced frequency of binge drinking.

7. 15. The planned modifications will increase the length of the intervention. Feedback from the participants indicated that additional text messages would be welcomed. Because of the affection that the intervention generated in many participants, it would seem sensible to taper the last few messages over several weeks.

8. 16. The control messages should be fewer in number and give less information about health. This will ensure that the control messages do not prompt a re-evaluation of drinking behaviour. This would make the control group messages more comparable to those used in conventional alcohol brief interventions.

Outcome assessment

1. 17. The primary outcome should remain the frequency of binge drinking. It is the most appropriate measure for men whose drinking pattern is episodes of very heavy drinking interspersed between periods of abstinence.

2. 18. The secondary outcome measures should be changed. Awareness of harms of drinking and benefits of moderated drinking should be omitted as levels of knowledge are high in the target group. Total consumption should be added as a secondary outcome. Goal setting and action planning could also be secondary outcome measures.

Process measures

1. 19. Additional process measure questions will need to be added to the intervention to check that the proposed new texts on goal setting and action have the desired impact.

2. 20. New process measures on self-efficacy should also be added.

The proposed revisions to the study protocol clearly demonstrate the value of conducting a feasibility study prior to a full trial. Although the broad structure of the study is unchanged, important changes will be made to all phases of the trial. These will improve internal and external validity and, crucially, increase the effectiveness of the intervention.

2.1 Existing research

Alcohol-related morbidity and mortality represent a major public health challenge. The cost of alcohol to society has been estimated at more than £55 billion per year in England1 and more than £2 billion per year in Scotland. 2 These costs occur through lost productivity, increased health-care and other public sector costs and through social disruption. Alcohol-related harms are not evenly distributed in the population. People who are socially disadvantaged are at a substantially higher risk of developing alcohol-related diseases. 3,4 Levels of binge drinking are highest among young and disadvantaged men. 5 There is a pressing need to change the culture of drinking among this group in order to prevent alcohol-related problems in later life.

2.2 Risks and benefits

The proposed intervention involves a novel method of delivery of a brief intervention to reduce hazardous drinking. Brief interventions to reduce harmful drinking have been widely used in health-care settings and no reports of risk have been made. 6 The potential benefits to the participants are the health and social benefits which accrue from adopting more moderate drinking habits. Society will benefit from reduced social disruption resulting from drunkenness, reduced healthcare costs and from reduced sickness absence from the health effects of excess consumption.

2.3 Rationale

The group who drink most alcohol and binge drink most frequently are young to middle-aged disadvantaged men. 5 Men aged 25–44 years are seldom in contact with health services and few are in full-time education. They will therefore not be reached by current initiatives to tackle excessive drinking. Targeting this group would lead to reductions in heavy drinking before chronic health harms develop. This group may be receptive to brief interventions: 27% of young men reported feeling the need to cut down on their drinking. 5

Brief interventions based on psychological theories have been developed to tackle alcohol-related problems. There is extensive evidence that brief interventions are effective. 6–9 Thus there is a need to develop alternative methods of delivering brief interventions to disadvantaged men aged 25–44 years. Given the extent of the current problem, the delivery methods need to be able to contact large numbers of individuals at low cost.

Text messaging has been used to modify adverse health behaviours10,11 and to increase healthcare uptake. 12,13 This approach is well suited to young to middle-aged men because their ownership of mobile telephones is high. This method has been successfully used as a smoking cessation tool in New Zealand11 and the intervention is being implemented nationally in a government funded programme. 14 Text messaging is also one component of the NHS stop smoking programme in England. 15

The text messages can be supported and reinforced by visual images. There is evidence that psychological theory can be embedded in visual media (e.g. posters, pictures in leaflets, films or animations) and alongside verbal and/or textual explanation, can improve patient understanding and self-care behaviours. 16 The use of images can enhance the coherence of the message (i.e. more clearly demonstrate how cause and effect are linked) by making the symptoms and their consequences appear less abstract and more concrete. Increasing coherence17 and concreteness18 in relation to illness and risk perceptions have been shown to influence attitudes19,20 and intentions and increase the likelihood of behaviour change. Visual media is acceptable to patients and, due to its less abstract and more concrete nature, may be more memorable than verbal or text based messages. 21,22 Images may therefore be an effective and acceptable adjunct to text messaging to increasing coherence and concreteness about alcohol-related harm and the benefits of moderate drinking.

The important question is whether text messaging could be helpful in tackling harmful drinking. Alcohol presents different challenges to the stop smoking campaign. Alcohol consumption is widely viewed as acceptable and in moderate amounts may be good for health. Further changing adverse health behaviours among disadvantaged groups is challenging because the uptake of health promotion interventions is much lower than in more advantaged groups. 23 Thus we need to determine whether a brief intervention delivered by mobile telephone will help moderate heavy drinking among young to middle-aged disadvantaged men.

Research questions of the full-scale trial of the novel intervention

Can a brief intervention delivered by mobile telephone:

1. Reduce the frequency of heavy drinking by disadvantaged men

2. Increase awareness of the harms of excessive drinking

3. Increase intentions to avoid becoming drunk

4. Increase self-efficacy for refusing drinks

The need for the feasibility study

The intervention to be used in the proposed trial has several components and thus is a complex intervention. The MRC framework for complex interventions recommends that the feasibility of all aspects of the trial be piloted and that the causal mechanism by which the intervention will work should be tested in advance of a formal trial. 24 The methods of recruitment to the trial and the retention of participants within it need to be piloted. The disadvantaged are recognised to be a difficult group to recruit so the proposed recruitment strategy needs to be tested. The potential for the intervention to influence beliefs and attitudes also needs to be assessed. Previous research has evaluated interventions delivered by face-to-face interview, often conducted by a health professional within a health-care setting. The acceptability of the use of mobile telephones to deliver the intervention and the potential of the intervention to influence drinking behaviour need to be assessed. We therefore propose to conduct a preliminary study to develop the recruitment strategies, to finalise the design of the intervention, to assess retention in the study and to investigate the likelihood of the intervention being effective.

Aims of the feasibility study

To investigate the feasibility and likelihood of success of a complex intervention to reduce the frequency of heavy drinking among young to middle-aged disadvantaged men.

Research questions of the feasibility study

1. What are the best ways to recruit and retain disadvantaged men in a study aimed at reducing the frequency of heavy drinking?

2. What is the type of content and timing of the delivery of a series of text messages and images that is most likely to engage young to middle-aged men?

3. Is the intervention likely to be an acceptable way to influence the frequency of heavy drinking?

Overview

The study will be conducted in three phases. Phase 1 will comprise six focus groups to develop the recruitment strategy, to optimise the design of the text messages and images and to determine the most acceptable sequence for their delivery. Phase 2 will involve the recruitment of 60 participants who will be randomised to receive either the alcohol intervention or a general health promotion intervention. The interventions will be delivered to mobile telephones using a programmed computer system. Participants will be followed-up for 3 months to assess recruitment and retention, willingness to respond to text messages and to complete the final assessment of drinking behaviour. Phase 3 will involve in-depth interviews with 20 participants to assess the acceptability of the intervention, the impact it had on their willingness to moderate their drinking and factors which might limit their ability to drink less.

For clarity of presentation Phase 1 will be described here because it is short and does not fit readily with the types of information elicited in Sections 5–10.

Phase 1 Focus groups

Focus group participants will be purposively recruited from several venues in areas of high deprivation: Sunday amateur football clubs, public houses and betting shops. Five of the six focus groups will be held with men aged 25–44 years. Potential participants will be men who have consumed eight or more units of alcohol during a single session on at least two occasions during the previous four weeks. The sixth focus group will be with women. A women only focus group is included because this will give a different perspective on men's reasons for drinking, refusal skills, awareness of harms and likelihood of responding to the intervention. Women who participate will be partners of men who meet the entry criteria.

The Focus groups will review the methods to be employed in Phase 2. Specifically it will investigate:

• strategies to recruit and retain disadvantaged men in a study on drinking

• the appropriateness of the theoretical approach underpinning the intervention

• the acceptability of the components of the intervention

• the acceptability of the recruitment process (credibility of source, invitation letter, initial screening telephone call).

The discussion on the design of text messages will explore:

• the types of questions that are acceptable; the language used to describe drinking and its consequences; beliefs and attitudes about the benefits and potential harms of alcohol; and attitudes to receiving messages on drinking (credibility, perceived relevance, likelihood of influencing drinking behaviour)

• the design of the images that will induce interest and stimulate a review of drinking habits

• total number of texts to be sent, frequency of sending texts, maximum length of texts

All interviews and focus group discussions will be digitally recorded and fully transcribed. Transcripts will be analysed using framework analysis. 25 Analysis will be facilitated by the use of text management software (NVivo) and carried out by a research fellow with formal training in qualitative research and practical experience of analysis. Two researchers will be involved in the analysis to ensure reliability of interpretation and coding.

Randomisation

The randomisation will be carried out by the Glasgow Clinical Trials Unit under the leadership of Professor J Norrie. After identifying and obtaining consent from an eligible participant the Research Assistant will contact the randomisation system at the Robertson Centre for Biostatistics, Glasgow Clinical Trials Unit. This randomisation system will be an Interactive Voice Response telephone system or accessed over the web. The randomisation system will then, after successfully randomising the participant, remotely contact the Dundee SMS text messaging server and the sequence of calls appropriate for that participant's randomised allocation will be set up.

Intervention delivery

The interventions will be delivered by an automated computer system, which will be programmed to send out text messages and images to mobile telephones in a predetermined sequence. The computer system will be devised and operated by the staff at the School of Computing at Dundee University under the direction of Professor I Ricketts.

The exchange of text messages with the clients will be via a secure server based within the School of Computing at the University of Dundee. Messages delivered to the client will appear to originate from the project's mobile telephone but the message content and client address will be assembled on the secure server and routed via the JISC funded JANET network to a UK based Mobile Network Service Provider and thereby to the clients. All replies from the clients will follow the reverse path. The Mobile Service Provider offers support for a variety of connections including email, web browser and individually tailored www solutions. In this feasibility study the team will provide the simplest solution compatible with providing an effective communication between the client and the project team. The secure server and associated software tools will be provided at no cost to the project.

Blinding

The researcher who collects both baseline and outcome data will not be involved in the randomization process or the delivery of the active and control interventions. Thus the researcher will be blinded to treatment group.

Stopping rule/Discontinuation criteria

The intervention is only delivered over a three month period. Extensive previous research on brief interventions to tackle harmful drinking have found no evidence of harm. The issue of discontinuation is not applicable to this study. However we will monitor any emerging safety issues such as reported increases in drinking or depression, which might be caused by the drinkers being confronted by these health messages about alcohol.

Study group

Men aged 25–44 years living in areas of high deprivation will be recruited. Deprivation is measured using the Scottish Index of Multiple Deprivation,26 which is similar to the English Index of Multiple Deprivation. Men will be recruited from the 25% of electoral wards with the highest deprivation scores. Individual level socio-economic position will be measured on all men recruited to the study. It will be measured using education, nature of housing and occupation (NS-SEC) following the recommendations of Galobardes et al. 27,28

Inclusion/exclusion criteria

Men will be included in the study if they have had two or more episodes of heavy drinking (≥ 8 units in a single session) in the preceding month. Exclusion criteria are: men who are currently attending care at an Alcohol Problem Service; and men who will not be contactable by mobile telephone for any part of the intervention period.

Recruitment strategy

Two recruitment strategies will be tested.

Strategy 1: Potential participants will be identified from GP practice lists which contain data on age, gender and postcode. Postcode will be used to derive the Index of Multiple Deprivation (SIMD) score. 29 Potential participants will receive a letter from their GP inviting them to take part. The telephone numbers of those willing to take part will be obtained using the techniques employed in a previous study by this group. 30 In that study telephone numbers were obtained for 99% of disadvantaged mothers of young children. Telephone numbers were obtained from a combination of GP records, extensive web searches of publicly available databases and further contacts with GP staff. Of those contacted by telephone 77% were recruited to the study.

Systematic reviews show that repeated attempts at contact and monetary incentives increase recruitment to research studies. 31,32 Up to four attempts at contact by telephone will be made. Men who agree to take part will be offered an initial £10 gift voucher to offset any charges incurred by receiving and responding to text messages. They will also be sent a £5 gift voucher for each week of the study that they respond to text messages, and a £10 voucher for completing the outcome assessment.

Strategy 2: Respondent-driven sampling is a recently developed technique for surveying hard to reach groups, particularly those who engage in stigmatized or illegal behaviours. 33,34 It was designed to overcome the limitations of other techniques such as snowball sampling and key informant sampling. The technique assumes that the target population are distributed through a number of socially networked groups and is thus suitable for a group behaviour such as drinking. It has been extensively and successfully used with injecting drug users and groups at high risk of HIV infection. 35 The sampling strategy begins with the identification of a small number of ‘seed’ individuals obtained from different locations. In this study seeds will be recruited from several venues in areas of high deprivation: Sunday amateur football clubs, public houses and betting shops. The seed individuals identify suitable subjects from their social networks and recruit them to the study. To prevent over recruitment by individuals with large social networks each seed individual can only recruit a maximum of five individuals.

A key element of the technique is the use of incentives to each seed person for taking part in the study and for each of the individuals they recruit. Thus the seed individuals will receive a £5 gift voucher for each person they recruit. All participants recruited by this method will also receive the sequence of gift vouchers as described for Recruitment Strategy 1 (for joining and responding actively to the text messages).

Initial screening and Baseline assessment

Potential participants will be screened by a telephone call from a researcher to establish current drinking levels. Those who report binge drinking (≥ 8 units in a single session) at least twice in the previous four weeks will be recruited. They will also complete a short structured questionnaire that will include the validated CAGE questionnaire for alcohol dependence. 36

Experimental intervention

A brief intervention to reduce harmful drinking will be delivered by text messages to a mobile telephone. A series of interactive text messages and images will be designed using messaging theory,37–39 social cognition models40 and systematic reviews of interventions to tackle alcohol problems. 6,8,9 The intervention has four components:

Message development

The design of the text messages will be based on current communication theory. This identifies the series of steps in the causal chain from message receipt to behaviour change. To be effective a message must be: attended to, comprehended, processed, accepted and acted on. 38 Communication theory identifies four features of a message which affect the likelihood of behaviour change: the source (i.e. credibility) of the message, its style and content, the nature of the recipient and the context (the circumstances in which the message is received). Each of these features affects the impact of the message on behaviour change. 14,47 The nature of the message comprises many facets including its length, content (number of arguments), language and style (such as use of images). Other design features are the personal relevance of the message,47 whether the arguments are gain-framed (emphasising the benefits of moderate drinking) or loss-framed37 and items included to maintain interest (such as interesting and unexpected statements). The design of the message content will be assessed by the user group (disadvantaged men aged 25–44) at the focus group stage.

Image development

The images will be developed by a collaborative team involving a sociologist, a psychologist, a computer scientist and design specialists from the Dundee 3D Visualisation Group. Team members (led by Dr Williams) have successfully created images linking obesity and risk of arteriosclerosis. The design process will embed psychological theory of behaviour change in the development of images. The images will increase participants' awareness of their susceptibility to alcohol-related harm and increase their confidence and skill in moderating alcohol consumption. The design follows a four stage sequential process in which professionals work with the user group (disadvantaged men aged 25–44) to review:

• The theoretical basis: the creation of conceptual content

• The structure: creating a visual narrative

• The ‘look’: visual rendering of narrative and concepts

• The interpretation and impact.

Delivery of the intervention

A series of 28 interactive text messages and images will be sent over a four week period. The frequency and timing of the messages will be determined following the focus group discussions. Each of the four components of the intervention will be addressed in several messages. Some of these messages will also ask a question which, when answered, will generate an appropriate automated response. A few messages of general interest, designed to promote retention in the trial, will also be sent.

Comparator intervention

The comparator group will receive the same number of text messages and images. These will cover the general health promotion messages from current government public health policy. 48 These include diet, physical activity, smoking and mental wellbeing. The text messages and images will be designed to maintain interest in study to ensure that the control group complete the outcome assessment.

Phase 3 Post trial evaluation

A more detailed assessment of the impact of the intervention will be made in a sub-sample of 20 randomly selected participants (10 intervention and 10 control). Face to face interviews will elicit their views on all aspects of Phase 2. It will explore their reasons for participating in the study and the stages of the recruitment process. It will also examine the ways that the delivery of the intervention could be improved, the aspects of the intervention that caused them to review their drinking patterns and consider moderating their drinking. It will also explore the factors which might limit their ability to drink less with the aim of identifying ways in which the intervention could be improved. The interviews will be recorded and transcribed. The transcripts will be analysed thematically to identify additional improvements that could be made to the recruitment process and the intervention.

8.2 Assessment of harms

This study involves a novel method of delivery of a widely used brief intervention to reduce harmful drinking. The method of delivery has been used for other types of health behaviour and no harms have been identified. However we will monitor any emerging safety issues such as reported increases in drinking or depression, which might be caused by the drinkers being confronted by these health messages about alcohol. In addition participants who report problems related to their drinking, either at the baseline assessment or follow-up will be advised to contact their GP.

Division of Clinical & Population Sciences & Education

Head of Department Professor I K Crombie

A study on health and alcohol

Participant information leaflet

We invite you to take part in a research study. Before you decide, we would like you to understand why the research is being done and what it would involve for you. We are therefore providing you with the following information. Please take time to read it carefully and discuss it with others if you wish. When you have read the information provided, one of our team will go through it with you and answer any questions you have. This will take about 10 minutes. Be sure to ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Thank you for taking the time to read this.

Purpose of the study

This is a study about health and alcohol consumption among young to middle-aged men. Some men in this age group drink too much and we want to find ways to encourage them to reduce the frequency of drinking at harmful levels. We therefore want to look at alcohol consumption among a group of men, find out about their reasons for drinking, their intentions about drinking in the future and how these change over time.

Men will be invited to take part if they have had at least two days in the past month where they have consumed more than eight units of alcohol in one session. (A unit of alcohol is half a pint of normal strength beer, one measure of spirits or one small glass of wine).

What we would like you to do

After you have read this leaflet and have had a few days to think about it, a researcher will call you back to see if you wish to take part. If you give consent you will be asked some questions about yourself and how much you drink to see if you are eligible for the study. If you are eligible, we will send you a series of text messages with images over the next four weeks. The men taking part in the study will be put into two groups who will receive different text messages. Three months after the telephone interview, the researcher will get in touch by telephone again to ask some more questions.

At the end of the three month period we would like to conduct longer interviews with a few of the men who have taken part. We will choose some names at random (20 of the 60 men involved in the study). If you are selected, the researcher will contact you by telephone or text message to arrange a suitable time and place for the interview.

Why have I been chosen?

Men living in areas of Dundee, selected by postcode area, are being invited to take part. Your GP has randomly selected men in this age group to be contacted to ask if they would be willing to take part. To take part you must be available to be contacted by mobile telephone over a three month period.

Do I have to take part?

It is up to you to decide whether or not to take part. We will explain the study and go through the information leaflet. If you do decide to take part you will be asked to give consent. To do this you will be asked to reply to a text message from us to confirm that you are willing to take part. Participation in this study is entirely voluntary and you are free to refuse to take part or to withdraw from the study at any time without having to give a reason and without this affecting your future medical care or your relationship with medical staff looking after you.

Expenses and payment

You will be given gift vouchers as a thank you for taking part in the study and to reimburse you for the cost of any text messages you send to us. You will be sent a £10 gift voucher after you have completed the first telephone interview. You will then receive a £5 gift voucher each week for four weeks if you respond to the text messages you have received. You will also receive another £10 voucher when you complete the second telephone interview. Finally, those who take part in the detailed interview at the end of the three month period will receive a further £10 gift voucher.

What are the possible benefits of taking part?

Throughout the study we will give you information on health issues. You may find these useful in helping you to make healthier choices.

Confidentiality

Any information collected during the course of the study will be maintained on a confidential basis and access will be restricted to people conducting the study. Your name will not be disclosed, nor will details of your answers be given to anyone. With your permission, the telephone interviews with the researcher will be recorded and typed up as a written document or transcript. The transcripts will then be examined to ensure that all of the important information has been captured. The transcripts will not contain your name or any information about you that would allow you to be identified. The only people who will have access to the transcripts are the researchers. Some of your comments may be included in a report on the study, but these will be completely anonymous.

What will happen to the results of the research study?

The overall findings of the study may be published in a scientific journal, but these will not mention you in any way. If you would like to receive information about the results of the study, please let us know, and we will forward a summary of the findings to you at the end of the study.

Who has designed and reviewed the study?

The study has been designed by a group of researchers from The Universities of Dundee, Glasgow and St Andrews and NHS Tayside. Funding has been provided by the National Institute for Health Research. The Tayside Committee on Medical Research Ethics A, which has responsibility for scrutinising all proposals for medical research on humans in Tayside, has examined the proposal and has raised no objections from the point of view of medical ethics. It is a requirement that your records in this research be made available for scrutiny by monitors from the University of Dundee and NHS Tayside, whose role it is to check that research is properly conducted and the interests of those taking part are adequately protected.

Concerns or complaints about the research

If you have a concern about any aspect of this study, you should ask to speak to [contact details given] who will do her best to answer your questions. If you remain unhappy and wish to complain formally, you can do this by contacting [contact details given] who is the project leader.

Thank you for taking the time to read this information sheet and considering taking part.

To obtain further information

If you have any questions about this research, please contact [contact details given] who will be happy to discuss the study or answer any questions you may have.

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