A revised teaching assistant-led extracurricular physical activity programme for 8- to 10-year-olds: the Action 3:30R feasibility cluster RCT

Article history

The research reported in this issue of the journal was funded by the PHR programme as project number 15/55/09. The contractual start date was in April 2017. The final report began editorial review in September 2018 and was accepted for publication in April 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Russell Jago has been a member of the Research Funding Board for the National Institute for Health Research (NIHR) Public Health Research (PHR) programme since October 2014. He is also partly funded by the NIHR Collaboration for Leadership in Applied Health Research and Care West (CLAHRC West) at University Hospitals Bristol NHS Foundation Trust. Jane E Powell was a member of the NIHR PHR Funding Board from June 2011 to September 2015. Chris Metcalfe is a member of the Clinical Trials Units funded by NIHR.

Copyright statement

© Queen’s Printer and Controller of HMSO 2019. This work was produced by Jago et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

2019 Queen’s Printer and Controller of HMSO

Benefits of physical activity

Physical activity is associated with a reduced risk of heart disease, stroke, type 2 diabetes mellitus, obesity and some cancers. 1 Physical activity is also associated with improved profiles for a number of risk factors, including insulin, glucose, blood pressure, body composition2 and emotional well-being in young people3 and adults. 1

Children’s physical activity levels

Despite the widely demonstrated benefits associated with being regularly physically active, data from the UK Millennium cohort study4 show that only 51% of 7- to 8-year-olds meet the recommendation of 1 hour of moderate to vigorous physical activity (MVPA) per day. Primary school is a key time for developing motor co-ordination and sport-related skills and for building children’s confidence and interest in physical activity. Physical activity levels in children have been shown to decline during primary school. 5,6 Making the most of these ‘skill-hungry’ years could be essential to the development of positive physical activity skills and attitudes. There is moderate evidence of physical activity behaviours tracking from childhood to adulthood;7 therefore, finding ways to foster physical skills and positive attitudes during these early years may help children engage in regular physical activity at secondary school and on into adulthood.

Previous school-based physical activity interventions

The primary school setting provides opportunities to reach large numbers of children in order to implement public health interventions. 8 Systematically reviewed evidence9 has indicated that the effectiveness of school-based physical activity interventions delivered during the curriculum is limited. The review concluded that where there was an effect this was mainly in studies of poor methodological quality. 9 Identified limitations included short follow-up, inadequate adjustment for potential confounders, lack of adjustment for children clustered in schools and the use of self-report measures of physical activity. 9 A 2012 review10 of physical activity interventions for children and adolescents, which included an objective assessment of physical activity, reported an average improvement of 4 minutes of MVPA per day in intervention participants compared with control participants. Of the 30 studies included in the review, only 16 were deemed to be of high methodological quality. Contributory factors to low-quality scores included high attrition, lack of intention-to-treat (ITT) analyses and no adjustment for the clustered nature of the data.

There is an absence of child physical activity programmes that have been shown to be effective and that are ready to be implemented by local public health teams. 11 The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework was developed to translate research into practice. 12 The RE-AIM framework strikes a balance between public health-focused interventions that have good internal validity (as examined in effectiveness trials) and public health-focused interventions that have good external validity (can be nationally implemented). 12 Numerous physical activity interventions have shown promise at the pilot/feasibility stage, but either they failed to achieve an impact in a definitive trial10 or, if an impact was achieved throughout a trial, this was not sustained during implementation. 13 As such, it is important to design physical activity interventions with future implementation in mind. A feasibility study can be used to identify changes to the study/intervention design that can enhance the external validity of the definitive trial evaluation. 14 One way to achieve this is to identify whether or not all elements of the RE-AIM framework can be assessed and then use the information to guide changes to the design. 11

Rationale for extracurricular interventions

The primary school curriculum is limited to 2 hours of physical education (PE) per week, making it challenging to implement curriculum-based physical activity interventions and providing little opportunity for children to meet public health guidelines or to develop their physical literacy. 15 Time immediately after school is discretionary time for children16 and could be utilised to promote physical activity. 17 Evidence shows that children who are inactive after school are less likely to meet physical activity guidelines;16 therefore, organised after-school programmes that maximise the opportunities for physical activity could be an effective means of engaging primary school children in more physical activity. 8,18 Owing to a lack of capacity among teaching staff, the current provision of extracurricular physical activity in primary schools is dominated by expensive external practitioners, such as football coaches,19 which is costly to the school or to parents, and caters primarily to children who are already active. Provision may have been enhanced since the UK government doubled the primary school PE Premium to £320M for all primary schools in England, which was available from September 2017;20 however, the external provider model remains expensive for schools.

Use of teaching assistants

Teaching assistants (TAs) are an important part of the school system. TAs support teachers in class management and teaching. The number of TAs has significantly increased in the UK since 2000 and they now constitute one-third of the workforce in UK schools. 18 Streamlined staff numbers in schools highlight the importance of utilising existing staff to deliver extracurricular programmes. Therefore, training TAs to deliver after-school programmes could be a low-cost means of helping children to be active. An aim of the study is to assess the feasibility, potential sustainability and cost-effectiveness of an after-school physical activity intervention delivered by TAs.

Use of self-determination theory

Interventions have been more successful when they are based on psychological theory than when they are not. 21 Psychological theory can be used to inform intervention design and facilitate the identification (ID) of key mediators of behaviour change. 21 Self-determination theory (SDT)22 may be particularly appropriate for understanding children’s physical activity. SDT focuses on motivation for behaviour and argues that those with autonomous motivation (i.e. doing physical activity because it is fun or personally valued) have more positive behavioural, cognitive and affective outcomes than those with controlled motivation (i.e. doing physical activity because of feelings of guilt or pressure from others). Evidence from the PE and sport psychology literature demonstrates that autonomous motivation is associated with positive physical activity outcomes in children and adolescents. 23 Previous research into UK primary school children shows that having intrinsic motivation is associated with higher levels of objectively measured physical activity. 24 Autonomous motivation and psychological well-being can be achieved when three innate needs are met: (1) autonomy (i.e. having choice about and ownership over one’s behaviour), (2) competence (i.e. feeling able and effective in one’s environment) and (3) relatedness (i.e. feeling a mutual sense of connectedness with others). Cross-sectional evidence supports the positive relationship between psychological need satisfaction and autonomous motivation in primary school children. 24 Thus, programmes that help children feel part of the decision-making process, confident and competent in their physical ability and part of a supportive team will increase their motivation to be and remain active.

Another feature of SDT is that it suggests that motivational quality is determined partly by the motivational climate created by leaders. 25 This is particularly appropriate for Action 3:30R (hitherto referred to as Action 3:30 for simplicity), as previous research has shown that TAs can be trained to provide curricular content in a safe environment, using a delivery style that fosters optimal motivation and development. 26 For example, TAs can enhance autonomous motivation by (1) being autonomy-supportive (e.g. involving children in decision-making), (2) providing structure (e.g. giving clear expectations, reasoning and guidelines) and (3) being interpersonally involved (e.g. showing empathy and interest). By doing this, TAs can have a positive effect on pupils’ motivation, behavioural engagement and psychological well-being. 25

Summary of formative work

An evaluation was recently completed of an after-school intervention, Action 3:30. 18 The original feasibility study was conducted in 20 schools and participants were Year 5 and 6 pupils (aged 9–11 years). Ten schools were allocated to the intervention arm and 10 schools were allocated to the control arm (normal practice). The intervention consisted of training TAs to deliver 60-minute after-school physical activity sessions twice per week for 20 weeks. The intervention was based on SDT. TAs were trained to facilitate sessions that covered a range of activities and provided support for pupils’ autonomy, competence and relatedness. 27 The results showed that the Action 3:30 intervention holds promise as a scalable physical activity approach. 26,28 The adjusted difference in weekday MVPA was 4.3 minutes higher [95% confidence interval (CI) –2.6 to 11.3 minutes higher] at the end of the intervention in the intervention arm. Sex-stratified analyses indicated that the intervention may hold more promise for boys (8.6 more minutes of weekday MVPA than control, 95% CI 2.8 to 14.5 more minutes) than for girls (0.15 more minutes of weekday MVPA than control, 95% CI –9.7 to 10.0 more minutes). The results from the process evaluation suggested that the intervention was implemented as planned and well received by schools, TAs and pupils. 26,28 Although the effect on mean levels of MVPA among boys was among the best that has been shown for physical activity interventions in children,21 more work is needed to improve the content for girls. In addition, findings from the process evaluation showed that improvements are required to improve attendance, recruit less active pupils and increase TAs’ ability to manage disruptive behaviour.

Rationale for the trial

The evaluation of the original Action 3:30 programme showed that training TAs to deliver after-school physical activity sessions holds promise. The issues raised from the original programme have been addressed in a revised intervention. The aim of the study is to test, in a feasibility study, whether or not the revised intervention leads to increases in the physical activity of both boys and girls, as well as whether or not it results in the recruitment of less active children and in higher attendance levels. In addition, the study aims to test whether or not it is possible to use the RE-AIM framework to assess the implementation potential of the intervention.

Aims and objectives

The study had six research objectives, underpinned by seven research questions.

Research design

The study had two components. Component A, intervention optimisation, is described in Chapter 3. Component B, detailed in this chapter, was a cluster randomised controlled feasibility study in primary schools to compare the Action 3:30 intervention with a usual-practice control. The trial included quantitative, qualitative, process and economic evaluations.

Protocol amendments

The original study protocol (version 1.0) was submitted to NIHR on 3 March 2017. Version 1.1 was submitted on 21 September 2017 with one change, and version 1.2 was submitted on 19 April 2018 with one further change. These revisions are detailed in Table 1.

Ethics

The study was granted ethics approval from the School for Policy Studies, University of Bristol. The trial was registered with Internal Standard Randomised Controlled Trial Register under the reference number ISRCTN34001941. The project was funded by the NIHR Public Health Research (PHR) programme (project number 15/55/09). It was agreed that any adverse events during data collection would be recorded and reported to the chairperson of the Ethics Committee and the chairperson of the Trial Steering Committee (TSC), but there were no such events.

Study population and recruitment

The study sought to recruit 12 primary schools in two local authorities (South Gloucestershire and North Somerset). The number of schools approached and the proportion recruited were recorded, as was the percentage of their pupils claiming free school meals (an indicator of socioeconomic status of the pupils’ families, i.e. higher is more deprived). To participate, schools needed to be willing to allocate space for two after-school sessions per week for 15 weeks between November 2017 and March 2018. To ensure that the sample represented local diversity, half of the schools recruited were above the local authority median for free school meals. Eight schools were recruited in South Gloucestershire and four were recruited in North Somerset (as the latter is a smaller local authority).

The study aimed to recruit 30 Year 4 and 5 pupils (aged 8–10 years) in each school, and 40% of the sample was to comprise girls. The pupils were recruited when they were in Years 3 and 4 (aged 7–9 years) during the summer term ahead of the intervention starting the following autumn. The only exclusion criterion was that pupils who were unable to participate in standard PE lessons could not take part. If more than 30 eligible pupils signed up to the study, pupils were randomly selected using a computer-based algorithm.

Two recruitment methods were tested to examine which was more effective in order to inform a recruitment strategy in a definitive trial. The two methods were designed to ensure that we recruited participants with a range of physical activity levels. Recruitment method A (briefing) involved a short briefing in each class to explain the study and to give out pupil and parent information sheets and consent forms. Recruitment method B (briefing plus taster session) involved the same as recruitment method A plus a 20- to 30-minute taster session led by coaches from Bristol City Council. The taster session aimed to give the pupils an idea of what the Action 3:30 after-school intervention would be like. It was also intended to allay any concerns about the level of physical activity that might be required to take part in the study and to highlight that the sessions would be enjoyable. Four schools in South Gloucestershire and two schools in North Somerset were randomly selected to receive recruitment method B. Written parental consent was obtained for each child. A brief ‘reason for non-consent’ questionnaire was sent home to parents who did not give their consent in order to explore why they did not want their child to take part.

Pre-baseline data (opt-out)

Before the main study commenced, all Year 3 and 4 children in all 12 schools were asked to complete the validated Physical Activity Questionnaire for Older Children (PAQ-C). 29,30 Data were collected in an opt-out consent process. Parents were informed of the measures on an information sheet and asked to return an opt-out form if they did not want their child to participate. In four of the schools in South Gloucestershire, accelerometer data from all Year 3 and 4 pupils were also collected via this opt-out process. This process was conducted in only four schools to assess the utility of the approach and to provide an indication of the potential additional resources that the research team would need if such an approach were used in a larger trial. These data were used to compare the levels of physical activity between pupils who did and pupils who did not consent to take part in the main study and they were treated as the baseline values for participants who subsequently took part in the randomised controlled trial.

Baseline data

Following recruitment and before randomisation, baseline data were collected from the selected children in each school. A summary of the measures can be found in Box 1. Participant age at baseline was calculated from parent-reported date of birth. Parental ethnicity was self-reported by selecting one of 13 descriptions based on the UK census. Pupils’ socioeconomic status was estimated using two measures: parent-reported highest level of education (i.e. up to General Certificate of Secondary Education or similar; Advanced levels/National Vocational Qualifications; first degree/diploma/Higher National Certificate/Higher National Diploma; or higher degree); and parent-reported postcode, which was used to ascertain Index of Multiple Deprivation (see Appendix 1) using English Indices of Deprivation 2010. 31 Accelerometer data that had been collected in the four schools during the opt-out process were used for baseline.

Parent public and patient involvement

Two public and patient involvement meetings were held with parents in two schools following recruitment and randomisation. Both meetings were held in control schools, one of which had received recruitment method A and the other of which had received recruitment method B. The aim of the meetings was to gather more information about why parents had not given consent for their children to join the study (following the completion of the reason for non-consent questionnaire) and how to overcome these issues, as well as the parents’ thoughts about the recruitment methods and materials.

Measures

Data were collected from all of the selected children (intervention and control) at two time points:

1. baseline – June 2017

2. follow-up (weeks 13–15 of the intervention) – February/March 2018.

Randomisation

School was the unit of randomisation. Schools were randomised to the control (n = 6) or intervention (n = 6) arm after baseline data had been collected. Randomisation was stratified by local authority (South Gloucestershire or North Somerset at a ratio of 2 : 1 in each arm) and recruitment method (recruitment method A or recruitment method B at a ratio of 1 : 1 in each arm). Randomisation and allocation were conducted by an independent member of the Bristol Randomised Trial Collaboration using Stata version 15.1 (2017; StataCorp, College Station, TX, USA). Two of the intervention schools were unable to provide staff to attend the intervention training programme and therefore did not deliver the intervention. This is described in more detail in Chapter 4. Therefore, four schools were intervention schools and six schools were control schools.

Blinding

Because of the nature of the study, it was not possible to blind the schools or the pupils, as they had to know whether or not they had been allocated to the intervention. It was also not possible to blind the trial manager or field workers, as they collected the outcome and process evaluation measures. The randomisation processes and primary and secondary analyses were conducted blind by the statistician in the Bristol Randomised Trials collaboration, who was then unblinded to conduct the complier-average causal effect (CACE) analysis.

Sample size

As this was a feasibility trial, no formal sample size calculations were performed. For safety reasons, the maximum number of pupils that could be enrolled in the main study was 30 per school, giving a maximum sample of 360 pupils. Potential sample sizes for a definitive trial were estimated using the derived intraclass correlation coefficient (ICC) for MVPA from this study and published ICCs from comparable studies and based on combinations of key parameters (type I and type II error).

The Action 3:30 intervention

Process evaluation

Qualitative analysis

To synthesise the wide range of qualitative data collected, the framework method52 was used, as it enables the production of a matrix of the data (from different participant groups), which allows for constant comparison between groups. The framework method also allowed a combined approach to the analysis, enabling themes to emerge inductively from participant accounts and specific issues to be explored deductively. Data were analysed using the following steps:

• Researchers from the study team (BT and AP) thoroughly read and re-read each transcript and listened back to audio-recordings to become familiar with the data set. Their initial impressions of the data were recorded.

• Initial codes were created from the central tenets of the underlying intervention theory (SDT22) to interpret the data. These codes examined whether or not the intervention supported autonomous motivation among the participants and the three needs support constructs (autonomy or feelings of choice; relatedness – a feeling of connection between the participants and the instructor; and competence). In addition, a predefined code, ‘school context’, was included to assess the differences between schools in intervention experience and implementation linked to their physical/social/policy environment. For the deductive analysis, the predefined codes were broad, the primary purpose being to categorise relevant information to be further interrogated to elicit more refined codes and interpretations. The deductive analysis codes are presented in Appendix 2.

• An analytical framework was developed to fit each informant group to avoid losing any key data. Four researchers (BT, AP, SS and RJ) met to discuss and refine a set of codes that could be applied to all transcripts using the following process:

  • Two researchers (BT and AP) independently read and analysed two transcripts from each informant group, met, and discussed and created draft frameworks for each informant group.

  • A third researcher (SS) read two transcripts from half of the informant groups (e.g. boy pupils, TAs) and a fourth (RJ) read the other half (e.g. girl pupils, school contacts) and made notes of the key codes/themes.

  • All four researchers met to discuss and refine draft frameworks.

• The two primary researchers then applied frameworks to remaining transcripts (with some level of double coding, i.e. each researcher coded two more transcripts from each stakeholder group) using NVivo (QSR International Pty Ltd, Warrington, UK). Any new codes that emerged were discussed, and amendments were made to each framework.

• Coded data were then charted into a framework matrix in NVivo. This summarised the data for each informant by category and included representative quotations. To ensure consistency within the research team, summarising techniques were compared.

• Data were interpreted and themes were generated in frequent meetings to review the matrix. The two primary researchers agreed on illustrative quotations to show the nature of each theme.

• The frameworks were triangulated to compare the codes for each informant group to assess the degree of convergence.

The qualitative analysis is reported in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines53 (Table 3) to optimise the credibility and transparency of the research.

Statistical analysis

Stata statistical software was used for all statistical analyses. Summary statistics were presented comparing the control and intervention arms at baseline and follow-up on demographics [age, ethnicity, socioeconomic status (using Index of Multiple Deprivation)] (baseline only), psychosocial variables and accelerometer variables, including MVPA. Where the distribution of the outcomes was approximately normal, mean values and standard deviations (SDs) were presented; otherwise, medians and interquartile ranges (IQRs) were presented. For binary/categorical variables, a number and percentage were presented. As this was a feasibility trial, the primary and secondary outcomes were reported using basic statistics to describe the recruitment, session attendance, accelerometer and questionnaire data. To avoid losing power when calculating average scores for the measure of autonomy-supportive teaching experienced by pupils (Sport Climate Questionnaire collected at three process evaluation time points), a multiple imputation approach was taken, which provides a more realistic representation of what would have been provided had all of the children provided complete data at all time points (see Table 17). Non-imputed data are also presented in Appendix 4.

For the accelerometer-assessed mean minutes of weekday MVPA outcome, the following analysis procedures were undertaken. All pupils providing measurements were included, as per their allocation, in an ITT primary analysis to assess the effectiveness of the Action 3:30 intervention to improve the mean minutes of MVPA per weekday among Year 4 and 5 pupils at follow-up using multivariable mixed-effects linear regression. Multivariable mixed-effects linear regression considers the hierarchical nature (i.e. the clustering) of participants within schools. The model included covariates for intervention arm, local authority (South Gloucestershire or North Somerset), recruitment strategy (taster session or not) and the baseline measurement of mean minutes of weekday MVPA. The difference in mean weekday MVPA between the two allocated arms was presented with its 95% CI. This was repeated with stratification by sex, with the differences in mean weekday MVPA between the two allocated arms being presented with 95% CIs for boys and girls separately. This model was adapted to secondary measures based on accelerometer estimates such as sedentary time. The total proportion of pupils meeting the UK recommendations of 60 minutes of MVPA per weekday was calculated based on the average minutes of MVPA across all valid weekdays.

The large majority of trial participants had indicated a willingness to join the Action 3:30 programme at the outset, before the allocation of their school to intervention or control, thereby ensuring allocation concealment. The ITT estimate was based on a comparison of these participating children between those whose school was allocated to intervention and those at schools allocated to control. Children who later joined their school’s ongoing programme at ‘re-enrolment’ made this decision knowing that they were at an intervention school; this fundamental difference prompted us to prespecify a separate analysis of the outcomes in these children, which, if justified, would then be combined using meta-analysis techniques with the ITT estimate.

A key issue when estimating the effect of the intervention in those children joining at re-enrolment is identifying an appropriate comparison group. It is not known which children in the control schools would have joined the intervention at the later opportunity, so the only unbiased comparison based on randomly allocated groups is between all children who did not indicate a willingness to join the Action 3:30 programme at the outset, comparing those at schools allocated to intervention with those allocated to control. This estimate is not equivalent to our primary ITT estimate; here we pilot a CACE method to obtain an unbiased estimate of the effect of the intervention in those who joined the intervention at re-enrolment. This CACE estimate is comparable with the ITT estimate from those children indicating a willingness to enrol at the outset. It is worth noting that both the ITT estimates and the CACE estimates disregard the number of sessions each child attends: the intervention effect is calculated for those children intending to join the programme, whether this is at the outset or the later opportunity.

The CACE estimate and its CI were obtained using the two-stage least squares approach. This method needs all eligible children at each school to provide the necessary measurements; in this pilot, we did this for four schools. The key aim here was to specify the method and consider the feasibility of the approach, as the estimates produced at this stage would not be usefully precise.

Governance

A local advisory group was formed, which included local authority physical activity staff from the two local authorities. The group met three times during the study: once during baseline data collection, once during the intervention delivery period to advise on school-related/intervention issues and once at the end of the project to provide feedback about the interpretation of the findings and the future sustainability and dissemination of Action 3:30. A Children’s Advisory Group was formed with children in the four intervention schools. Four children in each school (two boys and two girls) were recruited, one high active and one less active of each sex, to provide feedback about the intervention and raise any logistical issues. Three Children’s Advisory Group meetings were held during the intervention. A Trial Management Group was formed, comprising all of the applicants, the trial manager and the field worker. The Trial Management Group met once per month to discuss key issues. A TSC was formed, comprising an independent chairperson, two independent members and the study team. The TSC met three times during the study and provided independent scientific scrutiny of the study, support to the study team and guidance on how to progress to a definitive trial. A member of the local advisory group was invited to attend the TSC meetings to provide input.

Aim

The aim was to ensure that the intervention was optimised for participants and that its interest and appeal was maximised for both boys and girls.

Method

A sample session of the intervention was conducted in two schools in the summer term. One Year 5 class in each school was chosen to take part, as these pupils were of the target age but would not be eligible for the study because they would be in Year 6 when the intervention commenced in the autumn term. The sessions were delivered by Bristol City Council staff during a PE lesson. After the sessions, two separate focus groups (one with six boys and one with six girls) were conducted. Class teachers selected pupils with a range of activity levels for the focus groups. The pupils were asked to comment on their enjoyment of the session, their perception of how boys and girls interacted with each other, the teaching style and the ways in which the session could have been improved. Feedback from the first focus groups was used to improve the second sample session. Lessons learnt from all of the focus groups were used to improve the 30 session plans before the intervention commenced.

Focus group discussions were transcribed verbatim and anonymised.

Results

The analysis of the focus groups (n = 4) showed that all pupils were very positive about the sessions and rated them highly. There was no evidence of differences in response from boys and from girls, and therefore data are presented for each theme with indicative quotations from boys and girls where appropriate. The researcher-identified themes were agreed to be (1) variety, (2) teamwork, (3) level of activity, (4) potential improvements and (5) coaching style.

Summary

The results from the focus groups with Year 5 pupils showed that the sample sessions were well received by both girls and boys. The pupils enjoyed the sessions because they were fun, varied and different from usual PE lessons and encouraged teamwork with others with whom they did not usually play. Boys and girls enjoyed interacting and felt that the session would not have been as enjoyable had it been single-sex. The pupils liked that the coaches were encouraging and gave good critical feedback, which enabled them to improve their skills. Some of the pupils thought the sessions were active; however, others did not. Girls specifically suggested that smaller teams and more space to spread out would have improved the sessions because this would have enabled more people to get involved simultaneously. Introducing more rules into the games was also suggested, as this could have increased the activity level as well as adding more structure to the sessions. Pupils preferred that teams were chosen for them, rather than choosing their own teams, so that the games were equal and fair.

Results from these focus groups suggest that the revised session content appeals to both boys and girls but highlighted further refinements that were used to improve the 30 session plans and the intervention training programme. Table 4 presents the lessons learned and the changes that were made to the intervention to reflect these.

School recruitment

The study required participation of eight primary schools from South Gloucestershire and four from North Somerset, making a total of 12 study schools. Schools were approached based on the percentage of their pupils claiming free school meals and their intake size. Eleven schools in South Gloucestershire were invited to participate. Two schools did not respond to the invitations, one school declined to take part after the initial meeting and eight signed study agreements to take part. The agreements outlined the study role and what was expected of the school in terms of allocating space and staff time for the clubs and also the expectations that the school could have of the project team. In all schools, members of the project team met with the head teacher, provided an overview of the study and answered any questions during a face-to-face meeting. Sixteen schools in North Somerset were invited to participate. Eight schools did not respond to the invitations, four declined to take part after receiving the study information and four signed study agreements to take part. It is notable that the recruitment rate of South Gloucestershire schools was considerably higher than that of North Somerset schools. We believe that this reflects our long-established working relationship with South Gloucestershire Council and support from council staff in approaching schools. Table 5 presents the recruitment rates.

Progression criterion 1 of the study was to recruit at least 25% of the schools approached. Forty-four per cent of all schools that were approached agreed to take part, so this criterion was met. An aim of the recruitment process was to recruit half of the schools in each local authority from above the median free school meals percentage of that local authority. The median free school meals percentage is 8.5% in South Gloucestershire and 9.3% in North Somerset. Six and four schools in South Gloucestershire and North Somerset, respectively, were above this level, indicating that these schools were in more disadvantaged areas.

Participant (pupil) recruitment

School status

A total of 334 pupils were selected to take part in the study. Following randomisation, two schools (school 24 and school 28) that had been randomised to the intervention arm decided that they were unable to provide the intervention. For the purposes of this feasibility study, to obtain an indication of the impact of the intervention in those schools able to deliver it, these two schools were dropped from the primary analysis. Therefore, 165 pupils were randomly allocated to the control arm and 170 were allocated to the intervention arm. An interview was conducted with the key contact in school 28 to explore the school’s reasons for withdrawal, and those findings are presented in Chapter 6. School 28 agreed to continue to take part in the study (albeit without delivering the intervention) and therefore participated in follow-up measurements and post-study interviews. School 24 became unresponsive following its decision to withdraw from the intervention. Therefore, an interview could not be scheduled, and the school was withdrawn from the study and any further data collection.

Figure 1 presents the study Consolidated Standards of Reporting Trials (CONSORT)55 flow diagram and details of recruitment and retention throughout the study.

FIGURE 1.

The CONSORT flow diagram. Reproduced from Jago et al. 54 © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).

Reproduced from Jago et al. 54 © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).

Data provision

Data provision rates for all measures and accelerometer return are shown in Table 11, and these were similar at baseline and follow-up.

Baseline data

Baseline data are described in Tables 12 and 13. Data are presented as percentages in Table 12 and as means and SDs in Table 13. Overall, the trial arm were well balanced. Parent ethnicity varied slightly between the arms, with the control arm having a higher proportion of white British parents. Accelerometer-assessed MVPA and sedentary time were similar across the arms, as were psychosocial variables.

Table 14 presents a comparison of accelerometer-assessed MVPA at baseline between the trial arms for all participants and for boys and girls separately. Data are presented as means and SDs and percentages. Mean MVPA was similar between the trial arms for both boys and girls. In both arms, mean MVPA was lower for girls than for boys. In the control arm, girls did 10.89 minutes less MVPA than boys, and in the intervention arm, girls did 12.35 minutes less MVPA than boys. The total proportion of both boys and girls meeting 60 minutes of MVPA per weekday was similar between the arms. In both arms, approximately 19% fewer girls than boys met the 60-minute guideline.

Re-enrolment

Considering previous research, the study was designed to re-recruit pupils approximately half-way through the intervention if spaces became available. The number of spaces available was calculated by determining the average number of pupils attending each club on a weekly basis (from club attendance registers provided by the school) and subtracting that from the maximum capacity (n = 30 pupils). Table 15 presents the number of spaces available in each school and the number of pupils who expressed an interest in participating.

Teaching assistant attendance

Teaching assistants from all four intervention schools either were nominated by their school or volunteered to attend training and run the intervention in their schools. Two TAs from schools 25, 27 and 33 were recruited. Three TAs from school 32 volunteered. Eight TAs attended all 5 days of training and one TA from school 32 missed 1 day of the training.

Teaching assistant self-efficacy

Figures 2 and 3 show the results of the self-efficacy and perceived autonomy-support questionnaires completed by TAs before and after training and at three time points during the intervention. Measures of personal endorsement and intention to use an autonomy-supportive teaching style were completed pre and post training only (see Figure 3). Results from the teaching efficacy measure (see Figure 2) suggest that TAs became more confident across all teaching environment contexts in their ability to provide highly active after-school sessions under challenging circumstances following training and grew slightly more confident across all teaching contexts over the course of the intervention (process evaluation visit 3).

FIGURE 2.

Self-perceived TA teaching efficacy. PEV, process evaluation visit. Reproduced from Tibbitts et al. 56 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Reproduced from Tibbitts et al. 56 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

FIGURE 3.

Teaching assistant-perceived autonomy-supportive teaching style. a, Adapted version of the Sport Climate questionnaire,45 scale 1–7; b, Endorsement questionnaire,47 measured only pre and post training, scale 1–7. PEV, process evaluation visit. Reproduced from Tibbitts et al. 56 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Reproduced from Tibbitts et al. 56 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

The results of the personal endorsement item (see Figure 3) showed a small increase in mean score between pre (6.0 ± 0.31) and post (6.4 ± 0.57) training. Similarly, there was a small mean score increase in the intention to use item (see Figure 3) pre (6.7 ± 0.45) and post (6.8 ± 0.28) training. Results from the autonomy support measure (see Figure 3) show that TAs perceived that they adopted a more autonomy-supportive teaching style post training than pre training, and that they perceived this to have been maintained throughout the intervention. For example, TAs agreed that they provided their pupils with options and tried to understand their pupils’ perspectives before suggesting alternative ways of doing things. These results suggest that intervention delivery was consistent with underpinning SDT (objective 3c). Observational visits to schools at three time points during the intervention also affirmed this, as two project staff observed and agreed that an autonomy-supportive teaching style had been adopted by TAs in all four schools.

Session delivery (objective 3a)

Teaching assistants in all four intervention schools completed the log books (see Appendix 3), which were collected to assess intervention fidelity. As shown in Table 16, all 30 sessions were delivered in all four intervention schools. TAs described most of their sessions as partially delivered (69.2%), one-quarter of sessions as fully delivered, and a small number of sessions as not delivered at all (5.8%). Comments in log books and interviews with TAs (see Chapter 6) revealed that TAs felt that sessions were partially delivered because there was not enough time to complete all of the activities in the session plan. Furthermore, comments and TA interviews revealed that the sessions classified as not at all delivered were those where space had been limited and TAs chose to revisit previous session plans, which were more easily adaptable to the space, rather than deliver the current session plan.

Child-reported autonomy support and self-perceived exertion and enjoyment

Observations made by the project staff during three time points in each school aligned with results from the log books. All 12 sessions observed were thought to be either fully or partially delivered, the reason for partial delivery being the lack of time to fit in all of the activities. Overall, the intervention fidelity was good, and TAs used the session plans as intended.

Table 17 presents child-reported autonomy support scores at three process evaluation time points during the intervention, with scores derived from the short form of the Sport Climate Questionnaire. 45 Results are presented after multiple imputation and did not differ from the results produced before multiple imputation (see Appendix 4). The results show that children perceived their Action 3:30 leaders (the TAs) to be autonomy-supportive (as indicated by a high score) throughout the intervention, with little difference between time points. This may suggest that TAs were able to adopt an autonomy-supportive teaching style from the start of the intervention and maintain this throughout. This aligns well with the results shown in Figure 3, as TAs also perceived their teaching style to be autonomy-supportive throughout the intervention. Observational visits also support this finding, as project staff agreed that TAs successfully implemented the autonomy-supportive teaching techniques that had been taught during training. Overall, these findings suggest that the intervention was effective at underpinning SDT and that intervention fidelity was good.

Figure 4 presents child-reported mean perceived exertion and enjoyment at three time points during the intervention. It should be noted that the session number varied between schools at each process evaluation visit (process evaluation visit time point) and therefore the mean results reflect a variety of sessions and activities. The results of the self-perceived exertion measure suggest that children found the sessions towards the end of the intervention less tiring than those at the start. It is important to note that findings from the focus groups with a selection of pupils in each school suggested that they did perceive sessions to be active and tiring throughout the intervention period (see Chapter 6).

FIGURE 4.

Child self-perceived exertion and enjoyment. a, Score from 1 to 5; b, score from 1 to 10. PEV, process evaluation visit.

The results of the enjoyment measure show that children did enjoy all of the sessions observed, with little variation between time points (as indicated by mean scores of > 4). These findings suggest that the intervention was effective at promoting enjoyment and are reflected in the focus groups with pupils and interviews with TAs. During observational visits, project staff also agreed that there was minimal disruptive behaviour.

Session attendance (objective 3b)

Table 18 presents the number, mean and percentage of intervention (club) attendance in each school and overall. N represents the total number of pupils who were enrolled in the study and the club, including re-enrolment pupils. The results are presented for all pupils enrolled into the study (including re-enrolment pupils and those who did not attend a single session) and for just those pupils who participated in at least one session, including re-enrolment pupils. Mean attendance refers to the number of sessions attended by pupils (not the number of pupils). Mean attendance is presented as total pupils and for boys and girls separately. The number and percentage of pupils attending > 50% of sessions are also presented overall and by sex.

Overall, the results suggest that attendance in all four schools was good. Table 18 shows that among those who took part in at least one session, a mean of 19 sessions out of 30 were attended in total, with school 32 having the highest mean attendance (21 sessions). Mean attendance was similar between boys and girls and between schools, which suggests that the intervention was successful in engaging all pupils. To meet progression criterion 4, > 50% of pupils were required to attend at least 50% of sessions. This was achieved when analysing data from all pupils in the intervention arm and only those who took part in at least one club session. Across all schools, an average of 73.5% of pupils attended > 50% of sessions, with school 25 attaining the highest percentage (88.2%). The results suggest that the reach of the intervention was good for those who enrolled in the study and started the club.

Primary outcomes (accelerometer-derived weekday moderate to vigorous physical activity)

Table 19 presents the results comparing accelerometer-derived weekday MVPA between the control arm and the intervention arm at follow-up for the overall sample and by sex. MVPA at follow-up was very similar between the arms and, when adjusted for local authority, recruitment strategy and baseline MVPA, the lack of difference between the arms was reflected in the adjusted difference and 95% CI. Among boys there was a slightly higher MVPA in the intervention arm than in the control arm; however, the adjusted difference and CI shows no notable difference. Among the group of girls, MVPA did not appear to differ between the arms and this was also reflected in the adjusted difference and 95% CI. None of these differences and 95% CIs met the 10-minute benefit required for progression criterion 5.

Table 20 presents the results comparing the proportion of pupils meeting current daily MVPA guidelines at follow-up for the overall sample and for boys and girls separately across weekdays and weekend days. The proportion of pupils meeting the 60 minutes of MVPA per day did not appear to differ between the intervention arm and the control arm overall and among the boys and girls separately. This is reflected in the adjusted odds ratios and the 95% CIs. In both arms, the proportion of boys who met the guidelines was generally higher than the proportion of girls who met the guidelines.

Complier-average causal effect analysis

A CACE analysis was conducted to explore the treatment effect of those participants who joined at the second enrolment. This analysis included data from children joining at the first or second enrolments in an unbiased evaluation of the intervention effect (primary analysis of children indicating a willingness to join the intervention at the start). By way of context, for the ITT analysis (primary analysis) there were 10 schools: six in the control arm (number of pupils: 27, 21, 23, 25, 19 and 24) and four in the intervention arm (number of pupils: 17, 32, 29 and 35). These pupils are those who said that they were willing to join the intervention at the start of the study and were followed up for the ITT analysis. For the CACE analysis, three schools had complete accelerometer data for the entire year group at baseline and at follow-up, with a further school withdrawing from the study. Of the three schools, two were in the control arm (n = 53 and n = 24 pupils) and one was in the intervention arm (n = 27 pupils). These pupils did not say that they were willing to join the intervention at the start of the study and therefore could have enrolled had they had the chance at the point of second enrolment. In the one intervention school, one additional pupil joined at the re-enrolment point and provided useful data. We therefore examined, using a CACE methodology, whether or not there was a difference between the one pupil who re-enrolled from the intervention arm and those in the control arm who would have enrolled at the second enrolment had they had the chance, excluding pupils who enrolled in the first phase.

The unbiased CACE estimate of the intervention effect in children joining at the second opportunity is presented in Table 21; this is very imprecise as a result of having data from only one child who joined the intervention at this stage. The meta-analysis of the ITT analysis of children joining Action 3:30 at the first opportunity, and the CACE analysis of children joining Action 3:30 at the second opportunity, is also presented in Table 21 as a demonstration of the analysis we had planned were we to proceed to a full trial evaluation of the intervention.

Secondary outcomes

Adverse events

No adverse events were reported during the intervention delivery.

Sample size

Data from the feasibility study were used, along with those from other studies that detailed an ICC of the same outcome in school-based studies,57 to inform the sample size of a definitive trial to detect a 10-minute difference in weekday MVPA.

The ICC used in the top half of Table 24 was taken from the observed data in this feasibility study. An average cluster size of 27 and an ICC of 0.01 were used in the sample size calculation. Differing levels of alpha and power were investigated. A 20% loss to follow-up rate was conservatively estimated, and the number required per arm was inflated by 20% prior to further inflation by cluster size. The total number of schools needed varies from 8 (4 schools in each arm) to 16 (eight schools in each arm), depending on the power and significance level. The ICC used in the bottom half of Table 24 was taken from the primary outcome of the Bristol Girls Dance Project,57 which was a large cluster randomised trial of an after-school physical activity (dance) programme that focused on weekday MVPA among 11- to 12-year-old girls. The ICC from this study was chosen as an additional measure as this study is the largest UK after-school physical activity study for which an ICC has been reported and it therefore provides the best alternative data available. An average cluster size of 27 and an ICC of 0.001 were used in the sample size calculation. Differing levels of alpha and power were investigated. A 20% loss to follow-up rate was conservatively estimated, and the number required per arm was inflated by 20%. The total number of schools needed varies from 20 (10 schools in each arm) to 38 (19 schools in each arm), depending on the power and significance level.

School context

The context in which an intervention takes place could influence that intervention’s delivery, implementation or functioning58 and, as such, is important to try to understand. Various data were collected during the study to establish school context and its effect on the implementation of the intervention. Details of school size and pupil premium were provided by the school contact or school reception. A school context form enabled members of the study team to collect information on school-level physical activity provisions and school policies on promoting physical activity to staff and students. The components of the form that researchers used were taken from Jones et al. ’s48 audit tool, which was created to measure the physical school environment’s suitability for physical activity, and Lounsbery et al. ’s59 tool, which was devised to assess school policies regarding physical activity and physical activity throughout the curriculum. One form was completed per school. Each school was given a school physical activity suitability score, which is a sum of the scores from the cycling, walking, and sports and play provision components (Table 26). Scores were adapted from Jones et al. ’s48 original audit tool; facility quality was assessed on a more descriptive scale of 1–5 to improve measurement accuracy. Where a facility (e.g. a marked pedestrian crossing) was marked as present, scores were weighted as yes = 1 and no = 0. Where the quantity of facilities was provided, scores were weighted relative to the mean number of facilities across all schools: 0 = none are recorded, 1 = the number is between one and the mean plus one SD, 2 = the number is greater than the mean plus one SD. 48 The modal quality of physical activity provision is also reported, by school, in Table 26. Individual school responses measuring school physical activity policies and physical activity throughout the curriculum are reported descriptively in Appendices 6 and 7, but are described in full below. Each school received a ‘policy’ score (maximum score of 13) and ‘curriculum’ score (maximum score of 8). Please note that data are presented only for the six control schools and the four intervention schools that delivered the intervention.

School physical activity provision

As displayed in Table 26, the between-school variation in physical activity provision scores was high across all schools measured. Variation was highest in the cycling provision scale (range 5–48) and in the sports and play provision scale (range 27–81). Intervention and control school clusters did not differ in average scores for cycling provision, walking provision, facility provision, aesthetics or design of school grounds. Schools in the intervention arm had a slightly higher average score for sports and play provision than those in the control arm and, therefore, a higher overall physical activity suitability score. The average quality of facility provision was high in both intervention and control schools, with little variation among individual item quality scores. We may therefore suggest that intervention schools had, on average, an outdoor environment slightly more supportive of active games according to the validation of the original audit tool. 48

School policy on physical education provision and physical activity

Appendix 6 presents the scores for the school policy component of the school context audit tool. All schools reported having written or unwritten policies that supported physical activity for their student cohort in some way. Most schools (100% of control schools and 50% of intervention schools) reported having a policy that required PE to follow specific standards. In two control schools, this policy was not formally written/recorded. Two intervention schools had no such policy. Similarly, most schools (control arm, 83%; intervention arm, 75%) had a policy requiring a specific number of minutes be devoted to PE in the curriculum time each week. Half of control and intervention schools also had a written policy encouraging students to walk or cycle to school, and 100% of schools provided cycle training. By contrast, few schools reported consistently supporting staff physical activity through school policies. Only one school (in the intervention arm) reported having a policy supporting active travel for their staff, such as a cycle scheme. Similarly, only two control schools (33.3%) and one intervention school (25%) reported having a policy requiring that all school personnel receive professional development related to physical activity promotion. However, two-thirds of control schools and 100% of intervention schools provided facilities such as showers and cycle parking, which enable staff to travel by active means should they wish. Schools varied greatly in their allocation of budget to PE and PE equipment. All but one control school set aside a budget specifically for PE; however, the level of accountability for that money in different schools appears to differ randomly rather than be in favour of either the control or the intervention arm. PE teachers had some involvement in the spending of the PE budget in all schools; this did not differ by arm. On average, the control and intervention school arms did not differ in school policy scores. It was evident that policies focused mainly on supporting child physical activity, and fewer schools had policies beyond cycle parking and showers that supported or encouraged staff physical activity.

Aims

This chapter describes the methodology and results of an economic evaluation of the Action 3:30 intervention. Drawing on components of the RE-AIM framework,12 the aims of the economic evaluation of the project were to:

• assess the potential for examining cost variation in Action 3:30 delivery across school settings (implementation)

• assess the potential for change in HRQoL (effectiveness)

• assess the potential for sustaining the outcome of the intervention from a cost perspective (maintenance).

This short-term analysis estimates the cost-effectiveness and cost-utility of the Action 3:30 intervention, compared with no active intervention, over the 1-year period of the feasibility study. For these analyses, it was assumed that there were no differences in costs or intervention effects between the intervention arm and the control arm beyond the 1-year follow-up period. The intervention occurred over the course of one school year, and, as a result, costs were not discounted. Analysis was conducted in SPSS (Statistical Product and Service Solutions) version 22 (IBM Corporation, Armonk, NY, USA).

Methods

Results

After-school physical activity provision

Data on extracurricular physical activity provision and costs were collected from all intervention and control schools at baseline (see Appendix 8) and follow-up (see Appendix 9). Study schools provided a range of extracurricular physical activity opportunities at a cost ranging from £0 to £45 per session for schools and from £0 to £8.50 per session for parents. As shown in Table 31, on average intervention schools provided more extracurricular physical activity clubs per week at baseline (intervention, mean 3.25 ± 0.96; control, mean 2.83 ± 1.47) and at follow-up (intervention, mean 3.75 ± 2.06; control, mean 3.00 ± 1.67). The average club duration across time and condition was approximately 60 minutes. The delivery of extracurricular physical activity clubs cost intervention schools more, on average, at baseline (intervention, mean £4.62 per session ± £11.27; control, mean £0.41 per session ± £1.16) and at follow-up (intervention, mean £9.00 per session ± £15.83; control, mean £3.33 per session ± 9.85) compared with control school costs. Costs to parents were broadly similar across time and condition, with the mean cost per session ranging from £1.32 ± £1.62 to £2.61 ± £2.81.

A comparison of existing extracurricular physical activity provision with estimated Action 3:30 costs suggests that Action 3:30 may offer a more economically viable option for schools than delivery of alternative active after-school clubs. The average cost to schools per pupil attending one 1-hour session of existing extracurricular physical activity at follow-up was found to cost £5.91 (see Table 31), compared with an estimated mainstream cost of £1.64 (95% CI £1.43 to £1.86) per pupil per Action 3:30 session (see Table 31). However, this cannot be confirmed without a full trial in which the variation in costs between schools is considered.

Summary

A partial economic evaluation was conducted on cost changes alone. Action 3:30 is a low-cost intervention, comparing favourably with other after-school activities in that respect, and helps children to engage in non-sedentary activities. There was no evidence of a potential effect of the intervention on MVPA and, therefore, the potential cost-effectiveness could not be determined.

Self-reported responses to HRQoL measures by participants in the intervention arm and the control arm were similar at baseline and follow-up. This finding is consistent with previous studies57,62 in which HRQoL measures were found to be unresponsive among school children with ‘healthy’ profiles and supports the case for considering alternative HRQoL measures that are appropriate for use with this population.

The findings of this economic evaluation demonstrate that there is potential to examine cost variation in Action 3:30 intervention delivery across school settings and to estimate mainstream costs. The estimated cost of the Action 3:30 intervention is comparable with the cost of after-school physical activity interventions that have been reported in recent years. Findings indicate that Action 3:30 is inexpensive, with an estimated mainstream cost after 1 year of £1.64 per pupil per session, compared with the average school-level costs associated with existing extracurricular physical activity (£5.91 per pupil per session). As such, Action 3:30 may provide a more economically viable option for schools than existing school provision.

Reach

Using the definitions provided by the RE-AIM framework,12 and adapting the wording to apply it to the context of this process evaluation, reach is defined as:

The number, proportion and representativeness of individuals (TAs and pupils) who are willing to participate in Action 3:30 when offered the opportunity, as well as factors that may affect this.

Effectiveness

In the context of this process evaluation, effectiveness is defined as:

The impact of Action 3:30 on the children, club leaders and schools involved, as well as factors which affected, or may affect this.

Adoption

Within the context of this process evaluation, adoption is defined as:

The number, proportion and representativeness of schools (settings) or TAs (agents) who are willing to initiate Action 3:30, including factors that may affect this.

Implementation

In the context of this process evaluation, implementation is defined as:

Absolute fidelity as well as factors affecting the fidelity of the delivery of Action 3:30 when compared with intended delivery, both at the individual level (TA adherence to protocols and leader’s manual) and the structural level (school factors, resources, environment).

Maintenance

Within the context of this process evaluation, maintenance is defined as:

Factors perceived to affect potential maintenance of Action 3:30.

This section will present evidence of maintenance in Action 3:30 intervention schools, highlight the factors which may affect maintenance and propose potential improvements that may be useful to consider for future development and implementation of physical activity after-school programmes.

Trial design and evaluation

In addition to the RE-AIM analyses, a number of key trial design issues arose from the qualitative work. These are discussed below under the headings of Recruitment, School burden, Re-enrolment and Potential contamination.

Summary of main findings

The primary goals of the Action 3:30 project were to assess the feasibility of conducting a cluster randomised controlled trial of the Action 3:30 project and to assess the evidence of promise in terms of potential for positively affecting the weekday physical activity of boys and girls. Four out of five stated progression criteria were met. There was a high level of interest in the project, with 44% of the approached schools agreeing to join the project and 43% of eligible pupils expressing an interest in the study by returning consent forms. We were also able to show that the programme appealed to boys and girls, as 50% of the pupils who were consented to join the study were girls, and that pupils would attend, with 70% of pupils attending at least half of the 30 sessions. Thus, in terms of running a trial, the first four progression criteria were all met. It is, however, important to highlight that the intervention ran in only four out of the six schools that were randomly allocated to receive the intervention. In one school, this was because the school was unable to release two TAs to attend the training programme owing to limited capacity within the school, whereas the other school withdrew from the study and did not engage in any correspondence about the project. This may suggest that, in the current challenging financial climate, some schools may find providing support for TAs to attend additional training programmes more difficult. Thus, although recognising this important limitation, the evidence shows that it is possible to conduct a trial and that the first four progression criteria, all of which were focused on the practicalities of conducting a trial, were all met. The fifth progression criterion focused on evidence of promise for increasing weekday MVPA for both boys and girls in the intervention arm when compared with the control arm. The data presented in this study have shown that children who attend the Action 3:30 clubs engage in levels of MVPA comparable with those of children who engage in other activities, thereby suggesting that Action 3:30 replaced current provision, but there was no evidence that it provided additional MVPA. The lack of evidence of promise in terms of weekday MVPA indicates that, although all other progression criteria were met, and although it was feasible to run a trial of the Action 3:30 intervention, there is insufficient evidence of additional physical activity to warrant further examination of the Action 3:30 programme in a larger, more expensive, cluster randomised controlled trial. In the light of the challenges and expense of such approaches, it could be that further information on the utility of the Action 3:30 in relation to usual provision could be useful if it were provided using less resource intensive evaluation approaches, such as natural experiment designs.

Physical activity profile of participants

Physical inactivity is a leading risk factor for mortality,1 and, therefore, an aim of this study was to appeal to and recruit less active pupils who may be at highest risk in later life. Table 9 shows that, among those schools that participated in the ‘opt-out accelerometer’ phase, there was only a small difference in mean MVPA between those who consented to join the study and those who did not, which is in line with previous literature. 64–66 Although mean MVPA was relatively high at baseline, only 60% of control pupils and 62% of intervention pupils met the current physical activity guidelines at baseline (see Table 14). Together, these findings indicate that a range of pupils across the physical activity spectrum were recruited, including less active children. The qualitative results support this conclusion, as TAs in all four intervention schools felt that their clubs included children with a range of abilities and habitual physical activity levels. This contrasts with the previous Action 3:30 feasibility study18 and the work of others,67 in which participating children were already very active, and highlights that the changes made to the recruitment methods for this feasibility trial to engage more less active children were implemented effectively. Process evaluation measures of perceived exertion during the intervention suggest that pupils found the sessions harder at the beginning of the intervention than they did later (see Figure 4), which can be interpreted in a number of ways. Conceivably, pupils could have found later sessions easier because they had increased their fitness. However, as fitness was not measured, this cannot be established with any confidence. It should be noted that the perceived exertion scale used has been validated in a similar age group using a cycle ergometer exercise test and, therefore, the measure may not be generalisable to the mode of exercise in Action 3:30. 68

Previous research suggests that enjoyment and being active with friends are key determinants of physical activity in children. 69,70 Intervention pupils in this study listed reasons such as ‘inclusivity’ and ‘something fun to do with friends’ for signing up to the study, highlighting that focusing on enjoyment seems to have had a positive effect on recruitment. McGoey et al. 11 conducted a systematic review evaluating physical activity interventions in children using the RE-AIM framework and concluded that too few studies report evidence of external validity, such as representativeness of participants. In this study we have addressed this limitation by comparing baseline physical activity levels of consenters with those of non-consenters to the study, showing evidence of a representative sample of pupils as well as a recruitment method effective at engaging less active children to an after-school physical activity programme.

Qualitative data showed that some TAs perceived the activities in Action 3:30 to be different from activities in PE lessons because the former were centred around having fun rather than learning specific skills. In addition, some girls expressed that they enjoyed Action 3:30 more than PE because they felt more confident in their abilities. These findings add to the work of Cairney et al. ,71 whose results suggested that higher perceived competence was associated with greater enjoyment of PE and that enjoyment of PE declined among girls from the ages of 9 to 12 years. Together this evidence suggests that activities that promote competence and are enjoyable, such as those in Action 3:30, could be incorporated into PE lessons to increase pupil enjoyment. More recent work by Cairney et al. 72 also highlights that there is a positive relationship between participation in organised physical activity and participation in discretionary free-play over time. A suggested explanation for this association is that participating in organised physical activity supports the development of physical literacy and fundamental movement skills, which in turn enables children to participate in more free-play pursuits. With a longer follow-up period, it might also be observed that participants in Action 3:30 increase their discretionary physical activity levels over time as a result of increased physical literacy; however, our follow-up period was too short to allow us to observe this.

With the recent doubling of the PE and Sport Premium, primary schools are expected to develop or add to the physical activity provision they already offer in order to help pupils achieve the government-recommended guideline of at least 60 minutes of MVPA per day (30 minutes of which should be in school). 63 This key focus was highlighted in our qualitative findings, as some key contacts stated that they adopted Action 3:30 to help their schools meet targets. Addressing gaps in provision is a main consideration for schools when spending their PE and sport premium73 and is consistent with the theory of expanded, extended and enhanced opportunities in after-school programmes. 74 Therefore, primary schools may wish to adopt Action 3:30 because it helps to meet key government targets, in particular adding to their provision and engaging a range of pupils with a broad range of enjoyable activities.

Appeal of the Action 3:30 programme to girls

Despite the benefits of physical activity, it is well documented in the literature that girls are less active than boys6,75 and that the age-related decline in physical activity occurs earlier in girls than in boys. 5 Therefore, an aim of the study was to appeal to girls at the recruitment stage and increase MVPA as a result of the intervention. Our results indicate that Action 3:30 appealed to girls as well as boys and was successful in engaging girls throughout. Table 7 shows that 49% of the pupils recruited to the study were girls and Table 18 demonstrates that, on average, girls attended a similar average number of sessions to boys (19 vs. 20 out of 30, respectively).

Previous literature suggests that enjoyment, self-efficacy and perceived competence are positively associated with physical activity in girls. 76 Figure 4 indicates that pupils enjoyed the Action 3:30 sessions, which was reinforced in the focus groups with girls. We should note that because enjoyment was assessed quantitatively at only three time points in each school, this may fail to reflect the views of pupils who did not attend those sessions; however, children selected for the focus groups had varied attendance rates and so the views of pupils with low attendance were captured. In addition, our qualitative findings suggest that girls and boys felt a sense of autonomy support and improved competence to participate in other physical activities, although this was not borne out in the questionnaire-based measures of these SDT constructs. Together the evidence above indicates good intervention fidelity. Thus, the data presented show that the recruitment method was appropriately pitched and that the activities included in the sessions were suitable for both girls and boys. Therefore, Action 3:30 could be recommended to schools wanting to provide a physical activity offer that appeals to girls as well as boys.

Factors affecting attendance

Efforts were made to increase pupil attendance based on the findings from the previous Action 3:30 feasibility trial18 by identifying the days of the week that the club would run during recruitment and ensuring that schools held the agreed time slots in their extracurricular timetables. Overall, attendance across all schools was good. Table 18 shows that, on average, pupils attended 19 out of the 30 sessions, with 74% of pupils attending > 50% of the sessions. Attendance was similar to that in other studies11 and much higher than for another after-school-based programme, in which only 5% of children attended 50% of sessions. 77 Our attendance results indicate successful reach and fidelity of the intervention and confirm the utility of Action 3:30 as a scalable physical activity intervention.

The qualitative findings revealed that scheduling conflicts with other clubs was the main barrier to pupil attendance. Some pupils stopped attending Action 3:30 sessions on one or both days because they were doing other extracurricular activities; however, in interviews, TAs and key contacts expressed that this was the norm within schools. This suggests that children may prefer to switch between after-school programmes. Our quantitative results add to this, as pupils in intervention schools attended slightly fewer after-school clubs (excluding Action 3:30) than control pupils (1.70 ± 1.38 vs. 1.44 ± 1.28, respectively). Findings should be interpreted with caution, however, as the 95% CI for the adjusted difference in means included zero. Together, this may suggest that Action 3:30 replaced pupil’s existing provision rather than adding to it. Owing to the above findings, any intervention effect is likely to be attenuated and this may partly explain why an increase in MVPA was not achieved. Our previous work with primary school children18 and adolescent girls44 also found scheduling conflicts with other clubs to be the main reason for non-attendance. Our study is one of the few that documents reasons for non-attendance to after-school physical activity interventions in children. It is important for future studies to include measures to capture reasons for non-compliance and to perhaps consider when designing future interventions that children may prefer to switch between different activities.

Utility of Action 3:30 for continuing professional development

We have established through this study and our previous work18 that training TAs to deliver an after-school programme is feasible within primary schools. The qualitative results revealed that TAs and schools valued the training because it equipped TAs with the knowledge, resources and qualification to provide a range of physical activity sessions, which they could continue to use after the intervention had finished. Although TAs in the four intervention schools liked the training format, one school was not able to provide the intervention as it could not release staff for 5 full days. Some external stakeholders also expressed that they thought that 5 days was too much of a commitment for schools. More work may be needed to establish the minimum time required to adequately train school staff to deliver Action 3:30 or similar after-school programmes.

The government now expects primary schools to use their PE and Sport Premium to provide their staff with CPD and resources to help them teach PE and sport more effectively. 63 In 2014/15, upskilling and training staff was the most common use of the PE and Sport Premium, with less emphasis on employing new sports coaches. 73 This suggests that schools may prefer to develop their own workforce rather than employ external companies to run their after-school clubs. Therefore, Action 3:30 could be adopted by schools to offer CPD to their staff and help meet government expectations.

Impact of the Action 3:30 programme on motivation

There was evidence that the TA training reinforced and potentially increased TAs adoption and implementation of autonomy-supportive teaching/coaching practices and styles. Observations showed that this style could be maintained throughout the intervention programme. This supports previous research showing that teachers (including PE teachers) can be trained to teach in a way that creates a positive motivational climate. 78,79 Furthermore, pupils also perceived their TAs to be using an autonomy-supportive style. However, there was no evidence that the intervention held promise to affect the motivation variables measured (motivation types or need satisfaction). This may be a true finding and the intervention may hold no promise to affect these outcomes. However, the pupil’s scored their TAs as consistently highly autonomy-supportive and there was strong qualitative evidence from pupils and TAs for positive motivational outcomes. This conflict in findings may reflect a number of measurement issues. First, the scale used was validated in children in Years 5 and 6 (aged 9–11 years) but used in this project where children were aged 8–10 as it was impractical to further validate the scale in this age group prior to measurement. As such, the items may not have been clear to younger pupils and may not have been sufficiently worded to tap the qualitatively different types of motivation in this age group nor be sensitive to change.

Second, the baseline mean values for autonomous motivation and need satisfaction were high. This may indicate that the scales are not sufficiently sensitive to variation (i.e. being able to capture a diverse range of true scores) and that any potential effect on these variables could be limited by a ceiling effect.

Third, the measures assessed children’s motivation and need satisfaction at the contextual level (i.e. thinking about physical activity in general), which is one of three levels of motivation hypothesised within Vallerand’s hierarchical model of intrinsic and extrinsic motivation,80 in addition to situational and global. Situational motivation refers to the motivation and need satisfaction that children felt towards and when experiencing the Action 3:30 sessions. Given the consistent qualitative quotations that point towards situational need satisfaction within the Action 3:30 intervention, the lack of promise seen using the quantitative measures may be indicate either (1) a mismatch in the way motivation was influenced (situational level) and measured (contextual level) or (2) that any effect on situational motivation was not sufficient to effect broader motivation for physical activity. It could be argued that, as Action 3:30 sessions form only a small part of a child’s experience of physical activity (which includes school sport, PE, out-of-school sport, and being active with family and friends), they might not be expected to be able to shift broader motivation.

Overall, there is great need to develop more robust measures of the constructs within SDT for use with children to facilitate a better understanding of the effects of interventions which target them. Unfortunately, the funding landscape makes securing funds specifically to create and test these measures with children very difficult – yet without them our ability to measure the effects of our interventions on potential mediators is limited.

Cost of delivery compared with existing provision

The Action 3:30 intervention was found to be low-cost, with an estimated mainstream cost per school of £1482 per school and £62 per pupil, based on a class of 30 attending 30 1-hour sessions (£1.64 per pupil per session). The costs associated with children’s physical activity interventions are rarely reported, but the estimated costs of Action 3:30 are comparable with those that have been reported in recent years. 57,61,62 The majority of extracurricular physical activity provision provided by schools in this study was funded by the school or parents and this finding is comparable with the results of an audit of after-school club provision for children in Years 5 and 6 from primary schools in England. 19 Notably, estimated Action 3:30 costs were found to compare favourably with the costs associated with existing extra-curricular physical activity delivered in study schools. In the UK, many primary schools fund external agencies to provide extracurricular physical activity. These findings are therefore likely to appeal to schools as they suggest that Action 3:30 is economically viable and helps to engage children in non-sedentary activities. As Action 3:30 was not shown to be effective at increasing MVPA, nor was the study statistically powered to, it is not possible to comment on intervention cost-effectiveness. This study identified no difference between the intervention arm and the control arm responses to HRQoL measures. This finding is consistent with previous studies in which HRQoL measures were found to be unresponsive among school children with ‘healthy’ profiles,57 and supports the case for considering alternative HRQoL measures that are appropriate for a young and healthy population.

Implications for after-school delivery in the UK

Action 3:30 is a theory-informed intervention that is well liked by pupils and staff. Importantly, the programme was able to engage a wide range of pupils and it therefore provides a broader offer than existing provision, which tends to be dominated by team sports. 19 Including one-off training costs for staff, to deliver Action 3:30 costs approximately £2 per child per session, with this falling to £1.64 per child per session after the first year when the initial training and set-up costs have been met. This cost is considerably lower than the £5.90 per child per session average cost of existing provision that we found in this study. The findings, therefore, suggest that Action 3:30 is considerably less expensive than current provision, and as examination of the accelerometer data shows that children who attend Action 3:30 had levels of physical activity comparable with those of children who did not attend, it might be inferred that Action 3:30 achieves the same physical activity benefits as other clubs at a lower cost. A key focus of Action 3:30 is training TAs to build capacity within schools, thereby enabling the TAs to contribute to other aspects of physical activity provision, such as helping with or leading PE sessions within the school. This is an added benefit to schools that cannot be conferred by external providers. This approach is also consistent with a recent Office for Standards in Education, Children’s Services and Skills (Ofsted) report that highlighted that extracurricular programmes, such as Action 3:30, are a good way to broaden opportunities for children to learn new skills and be physically active. 81 As such, the results of this study provide evidence that training existing staff to deliver physical activity via schemes such as Action 3:30 is a viable approach for primary schools that is consistent with Ofsted guidance, appealing to schools and staff members because it counts as professional development, and is less expensive than existing provision, with the added benefit of developing the skills of key workforce members.

Comparison with international data

A previous systematic review of physical activity interventions delivered in the after-school period has reported a pooled intervention effect of approximately 5 additional minutes per day of MVPA for children who attend after-school physical activity interventions. 82 The results reported here suggest that the Action 3:30 did not lead to additional MVPA and that children who attended Action 3:30 engaged in the same amount of MVPA as children in control schools. However, comparisons with the current evidence base are challenging as the bulk of the work in the extended school day has occurred in the USA, a different context in which after-school provision is dominated by several large organisations such as the Young Men’s Christian Association (YMCA). The US programmes have therefore focused on maximising the quality of the provision by training staff and providing resources as part of policy-level interventions to increase after-school staff’s engagement with physical activity. 83 For example, Weaver et al. 84 assessed the effect of a professional development programme with the YMCA after-school staff and showed that the training programme increased the proportion of staff engaged in physical activity with children from 26% to 37%. The same study also highlighted that greater implementation of the strategies to help children to be physically active and consume better-quality snacks in the after-school period was associated with a greater percentage of boys engaging in 30 minutes of MVPA after school, with 42% of high-implementing settings meeting the threshold compared with 27% in low-implementing settings85 (there were no differences in the MVPA of girls in high- and low-implementing settings). Collectively, this body of evidence supports improving the quality of the provision to help children be as active as possible during the after-school period. Translating these findings to the UK is challenging because the provision is very different, with multiple external and internal providers that are school specific and a range of revenue models in which some programmes are revenue-neutral, some cost money to provide and some provide income for the school. It is also important to highlight that there is a lack of a quality assessment framework for physical activity in the after-school setting in the UK and, as a result, there is no current mechanism for translating the US-based evidence to the UK context.

Implications for research

The data presented in this report have shown that training existing staff to deliver an after-school physical activity programme is a viable approach for schools but that the programme did not yield any increases in physical activity levels, with the process data suggesting that this is because the children may have simply switched from one programme to another. As previous research has shown that activities in the after-school period are important for helping children to meet the Chief Medical Officer recommendation of 1 hour of MVPA per day, the challenge is how to maximise physical activity in the programmes that children already attend. 17 Thus, it may be the case that research should focus on maximising the quality of the current provision by using approaches such as those adopted in the USA as opposed to creating new provision such as Action 3:30. Therefore, there is a need to identify the types of current provision, the quality of that provision and how it could be improved. TAs do not routinely receive training in physical activity provision and so the Action 3:30 approach is novel and shows that TAs delivering physical activity programmes is a viable method that is likely to be more cost-effective than using external sports coaches. It is, however, also important to recognise that Action 3:30 is a flexible approach in terms of delivery mode, and it may be that elements of the programme structure could be changed, such as delivering only once per week, which may be a useful option for a number of schools. We have used the RE-AIM framework as an overarching structure to inform the study design and guide the process evaluation. Use of the framework for the process evaluation has facilitated breaking down the analysis into all of the key issues that are essential to increasing the external validity of research. Future studies should consider using the RE-AIM framework12 to evaluate interventions and present process evaluation results, as has been demonstrated in this study.

Utility of the opt-out consent and complier-average causal effect analyses

A novel aspect of this study was the use of a CACE analysis to incorporate data from participants who joined the study at a later enrolment point. This method was used to examine the feasibility of this alternative design, which was intended to mimic the usual organisational practices of schools, thereby increasing external validity. Those schools in which baseline and outcome data were collected for the whole year group contributed to a demonstration of how any benefit for those children joining the programme at the second enrolment could be estimated without bias. Those children who volunteered and were selected to join the programme at the first enrolment (determined prior to random allocation and so known for schools in both arms) were excluded from this analysis. A CACE approach was taken, which analysed those enrolling at the second opportunity in the intervention schools against a comparable group of children in the control schools. It is not possible to identify that ‘comparable group of children’ using observed measures; the CACE approach uses a statistical model with the following assumptions to estimate the outcome in that group of children: (1) owing to the random allocation of schools to intervention and control arms, the proportion of children observed to enrol at the second opportunity in the intervention arm would have been mirrored by children in the control schools had they been given the opportunity; (2) children observed not to enrol in the intervention arm would have the same outcome as children in the control arm who would not have enrolled had their school been in the intervention arm; that is, outcome in these ‘non-enrollers’ is not affected by allocation to the intervention or control arm. Consideration was given to whether or not it was useful to combine this estimate with that for the first enrolment children using meta-analytic methods. Thus, the analyses have shown that the method is feasible and that such approaches can be conducted. However, as very few children were re-enrolled in the one intervention school with complete data, the utility of this method for this project was limited. Furthermore, as noted above, this approach was reliant on opt-out consent data. Collecting physical activity data using an opt-out consent approach yielded excellent recruitment rates of > 98% (see Table 6) and added only a very small, and acceptable, burden to schools (see Chapter 6). However, this approach may not be feasible in primary schools in the future as the new General Data Protection Regulation legislation limits the use of opt-out consent processes in the European Union. 86 Thus, the approach is technically feasible, but it is unlikely to be useful and relevant in this current legislative context.

School context

Although no meaningful differences were observed between the overall school context scores of intervention and control schools in this study, between-school variation in school context scores was high in relation to the physical environment component scores. With only four schools delivering the intervention in this study, it is hard to assess what impact the school context components may have had on intervention implementation or effectiveness. However, context has the potential to greatly influence aspects of intervention delivery and impact58 and should be considered in large-scale school-based interventions. A key consideration for future research is how best to utilise school context data in ways that provide insight into the effect of school context on young people’s physical activity and on the delivery or effectiveness of interventions.

Specific research recommendations

• Research should invest in interventions that maximise the quality of existing after-school physical activity provision rather than create new opportunities in an already-saturated market.

• Work is needed to develop a standardised quality assessment framework for after-school physical activity provision in the UK that would make comparison with international research (e.g. from the USA) more feasible and make it possible to evaluate the quality of existing after-school provision.

• Further exploration is needed of the impact that school context components may have on physical activity intervention implementation in educational settings.

• The RE-AIM framework should be used to evaluate interventions and present process results in order to promote rigour and provide a platform to more reliably examine the external validity of research.

Strengths and limitations

The major strength of this study is the rigorous design, which has enabled the assessment of clear research questions that have been mapped onto specific progression criteria. Rigour and transparency were further enhanced by reporting the study in accordance with the TIDieR (Template for Intervention Description and Replication) framework,87 the COREQ guidelines53 and the CONSORT criteria. 88

A strength of the study was its reach. A whole-year-group approach was taken, as the study included all pupils in Years 4 (aged 8–9 years) and 5 (aged 9–10 years) in the 12 schools involved in the study. Physical activity data (either self-reported plus accelerometer or self-reported only) were collected for > 98% of eligible pupils pre baseline in the ‘opt-out’ phase of the study in order to compare pupils who did and pupils who did not sign up to the study. Both schools with a high percentage and schools with a low percentage of free school meals, indicating low and high deprivation, respectively, were recruited. Pupil recruitment rates at baseline were relatively high, a range of pupils consented to join the study, including less active children and girls, and attendance rates were high throughout the intervention. Further strengths are that an objective measure of physical activity (accelerometers worn for 7 days) was used and data provision rates were high for all measures at both baseline and follow-up. A re-enrolment point was offered approximately half-way through the intervention to increase the external validity of the study, which was received well by schools. Throughout the study, local advisory group meetings were held to take account of and learn from external stakeholders who had knowledge of local primary schools, and Children’s Advisory Group meetings were held with participating pupils to ascertain how the programme was being received in the intervention schools.

A notable strength is that an extensive and robust mixed-methods process evaluation was conducted using the RE-AIM framework. 12 Engagement with a range of well-informed external stakeholders to explore the potential sustainability of a programme such as Action 3:30 provided valuable insights into the ‘real world’ suitability of the design and applicability of the programme; information that would be beneficial to anyone designing after-school interventions. The process evaluation results revealed that the intervention had good fidelity. Direct observations were used to strengthen the assessment of intervention fidelity, which aligned with the process evaluation results. One limitation of the process evaluation was that insights from stakeholders extolled the value of evidence for programmes such as Action 3:30 without actually describing what counts as evidence, which would be useful to guide future applied research in this area. This perhaps reinforces the importance of working to enhance existing provision rather than creating new provision without clear guidance on the type of evidence of most value to commissioners.

The small number of participating schools meant that the study was not powered to detect differences between the intervention arm and the control arm and cannot be deemed fully representative of the population of all schools. However, this was inherent in the feasibility randomised controlled trial design of the study, which looked only for evidence of promise. Two schools that were allocated to the intervention arm were unable to deliver the intervention and so their data could not be used in the follow-up analyses, which reduced the sample size further and the representativeness of the intervention arm. In one instance this was because of a lack of capacity to release staff for training owing to challenges in the school. We do not know why the other school withdrew from the study, as it ceased communication with the project team. Qualitative data were collected from the first of those schools to determine its reasons for dropping out, but data could not be collected from the other school and so its reasons for dropping out are unclear and the ability to learn from the situation in this school is removed. It therefore seems plausible that limited capacity may have also been a reason why other schools did not agree to join the study, but we do not have data to confirm this assumption. The study was limited to only two areas in the south-west region of the UK and within this region there was variation in interest in and response to the programme and so generalisability to other areas of the UK and a wider range of schools may also be limited.

Where possible, objective measures were used. However, by necessity, a reliance on self-reported data to measure SDT constructs and HRQoL, and to collect demographic information from parents, made our data susceptible to reporting bias. The self-report measures of SDT-based constructs showed no evidence of change. It is not clear if this is a function of the lack of an intervention effect or a weakness of the scales and, therefore, more work may be needed to assess whether or not these measures can be improved. It is also important to note that although accelerometers provide objective assessments of physical activity, we assessed only 1 week of behaviour at each assessment, and other activities outside these periods will be under-represented. Similarly, accelerometers do not provide information on the actual behaviours that participants perform and can under-represent some activities, such as cycling. 89 There are also limitations in the qualitative focus groups that were conducted with the participants in that these could not cover all possible topics as the time was limited. It would have been helpful to have been able to garner more information about other activities in which the children engaged and the impact that participating in additional activities may had on attendance and overall levels of physical activity.

Contributions of authors

Russell Jago (https://orcid.org/0000-0002-3394-0176) (Professor of Paediatric Physical Activity and Public Health) was the principal investigator on the grant funding the work and Simon J Sebire (https://orcid.org/0000-0001-7994-0844) (Senior Lecturer in Physical Activity and Public Health), Chris Metcalfe (https://orcid.org/0000-0001-8318-8907) (Professor of Medical Statistics) and Jane E Powell (https://orcid.org/0000-0002-1828-1184) (Professor of Public Health Economics) were co-applicants.

Russell Jago, Byron Tibbitts (https://orcid.org/0000-0001-5818-7080) (Senior Research Associate, Trial Manager) and Alice Porter (https://orcid.org/0000-0001-5281-7694) (Field Worker) wrote the first draft of the report.

Byron Tibbitts and Alice Porter were responsible for the process evaluation and completed the first drafts of the process evaluation chapter, with support from Simon Sebire. Byron Tibbitts and Alice Porter collected all process evaluation data including conducting interviews and focus groups. Byron Tibbitts, Alice Porter, Russell Jago and Simon Sebire analysed the qualitative process evaluation data.

Chris Metcalfe and Emily Sanderson (https://orcid.org/0000-0003-2268-4194) (Research Associate in Medial Statistics) led the statistical analyses and reporting of the trial and served as the main links to the Bristol Randomised Trials Collaboration.

Jane E Powell and Emma Bird (https://orcid.org/0000-0002-9603-3434) (Senior Lecturer in Public Health) were responsible for the economic evaluation design and analyses and completed the first draft of the economic evaluation chapter.

All authors made contributions to sections of the report and critical comments on drafts of the monograph and approved the final submission.

Publications

Tibbitts B, Porter A, Sebire SJ, Metcalfe C, Bird E, Powell E, Jago R. Action 3:30R: protocol for a cluster randomised feasibility study of a revised teaching assistant-led extracurricular physical activity intervention for 8- to 10-year-olds. Pilot Feasibility Stud 2017;3:69.

Jago R, Tibbitts B, Sanderson E, Bird EL, Porter A, Metcalfe C, et al. Action 3:30R: results of a cluster randomised feasibility study of a revised teaching assistant-led extracurricular physical activity intervention for 8 to 10 year olds. Int J Environ Res Public Health 2019;16.

Tibbitts B, Porter A, Sebire SJ, Bird EL, Sanderson E, Metcalfe C, et al. Action 3:30R: process evaluation of a cluster randomised feasibility study of a revised teaching assistant-led extracurricular physical activity intervention for 8 to 10 year olds. BMC Public Health 2019;19:1111.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to available anonymised data may be granted following review.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care.