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Supplementary Material 2

Additional file 1:. Data collection instruments

Background Process evaluations are critical for interpreting and understanding outcome trial results. By understanding how interventions function across different settings, process evaluations have the capacity to inform future dissemination of interventions. The complexity of Get others Active (GoActive), a 12-week, school-based physical activity intervention implemented in eight schools, highlights the need to investigate how implementation is achieved across a variety of school settings. This paper describes the mixed methods GoActive process evaluation protocol that is embedded within the outcome evaluation. In this detailed process evaluation protocol, we describe the flexible and pragmatic methods that will be used for capturing the process evaluation data. Methods A mixed methods design will be used for the process evaluation, including quantitative data collected in both the control and intervention arms of the GoActive trial, and qualitative data collected in the intervention arm. Data collection methods will include purposively sampled, semi-structured interviews and focus group interviews, direct observation, and participant questionnaires (completed by students, teachers, older adolescent mentors, and local authority-funded facilitators). Data will be analysed thematically within and across datasets. Overall synthesis of findings will address the process of GoActive implementation, and through which this process affects outcomes, with careful attention to the context of the school environment. Discussion This process evaluation will explore the experience of participating in GoActive from the perspectives of key groups, providing a greater understanding of the acceptability and process of implementation of the intervention across the eight intervention schools. This will allow for appraisal of the intervention’s conceptual base, inform potential dissemination, and help optimise post-trial sustainability. The process evaluation will also assist in contextualising the trial effectiveness results with respect to how the intervention may or may not have worked and, if it was found to be effective, what might be required for it to be sustained in the ‘real world’. Furthermore, it will offer suggestions for the development and implementation of future initiatives to promote physical activity within schools. Trial registration ISRCTN, ISRCTN31583496 . Registered on 18 February 2014.

PURPOSE: To examine adolescent experiences and perspectives of the GoActive intervention (ISRCTN31583496) using mixed methods process evaluation to determine satisfaction with intervention components and interpret adolescents' experiences of the intervention process in order to provide insights for future intervention design. METHODS: Participants (n = 1542; 13.2 ± 0.4 years, mean ± SD) provided questionnaire data at baseline (shyness, activity level) and post-intervention (intervention acceptability, satisfaction with components). Between-group differences (boys vs. girls and shy/inactive vs. others) were tested with linear regression models, accounting for school clustering. Data from 16 individual interviews (shy/inactive) and 11 focus groups with 48 participants (mean = 4; range 2-7) were thematically coded. Qualitative and quantitative data were merged in an integrative mixed methods convergence matrix, which denoted convergence and dissonance across datasets. RESULTS: Effect sizes for quantitative results were small and may not represent substantial between-group differences. Boys (vs. girls) preferred class-based sessions (β = 0.2, 95% confidence interval (CI): 0.1-0.3); qualitative data suggested that this was because boys preferred competition, which was supported quantitatively (β = 0.2, 95%CI: 0.1-0.3). Shy/inactive students did not enjoy the competition (β = -0.3, 95%CI: -0.5 to -0.1). Boys enjoyed trying new activities more (β = 0.1, 95%CI: 0.1-0.2); qualitative data indicated a desire to try new activities across all subgroups but identified barriers to choosing unfamiliar activities with self-imposed choice restriction leading to boredom. Qualitative data highlighted critique of mentorship; adolescents liked the idea, but older mentors did not meet expectations. CONCLUSION: We interpreted adolescent perspectives of intervention components and implementation to provide insights into future complex interventions aimed at increasing young people's physical activity in school-based settings. The intervention component mentorship was liked in principle, but implementation issues undesirably impacted satisfaction; competition was disliked by girls and shy/inactive students. The results highlight the importance of considering gender differences in preference of competition and extensive mentorship training.

We assessed which intervention components were associated with change in moderate-to-vigorous physical activity (MVPA) and wellbeing through proposed psychosocial mediators. Eight schools (n = 1319; 13-14 years) ran GoActive, where older mentors and in-class-peer-leaders encouraged classes to conduct two new activities/week; students gained points and rewards for activity. We assessed exposures: participant-perceived engagement with components (post-intervention): older mentorship, peer leadership, class sessions, competition, rewards, points entered online; potential mediators (change from baseline): social support, self-efficacy, group cohesion, friendship quality, self-esteem; and outcomes (change from baseline): accelerometer-assessed MVPA (min/day), wellbeing (Warwick-Edinburgh). Mediation was assessed using linear regression models stratified by gender (adjusted for age, ethnicity, language, school, BMI z-score, baseline values), assessing associations between (1) exposures and mediators, (2) exposures and outcomes (without mediators) and (3) exposure and mediator with outcome using bootstrap resampling. No evidence was found to support the use of these components to increase physical activity. Among boys, higher perceived teacher and mentor support were associated with improved wellbeing via various mediators. Among girls, higher perceived mentor support and perception of competition and rewards were positively associated with wellbeing via self-efficacy, self-esteem and social support. If implemented well, mentorship could increase wellbeing among adolescents. Teacher support and class-based activity sessions may be important for boys' wellbeing, whereas rewards and competition warrant consideration among girls.

BackgroundAdolescent physical activity levels are low and are associated with rising disease risk and social disadvantage. The Get Others Active (GoActive) intervention was co-designed with adolescents and teachers to increase physical activity in adolescents.ObjectiveTo assess the effectiveness and cost-effectiveness of the school-based GoActive programme in increasing adolescents’ moderate-to-vigorous physical activity.DesignA cluster randomised controlled trial with an embedded mixed-methods process evaluation.SettingNon-fee-paying schools in Cambridgeshire and Essex, UK (n = 16). Schools were computer randomised and stratified by socioeconomic position and county.ParticipantsA total of 2862 Year 9 students (aged 13–14 years; 84% of eligible students).InterventionThe iteratively developed feasibility-tested refined 12-week intervention trained older adolescents (mentors) and in-class peer leaders to encourage classes to undertake two new weekly activities. Mentors met with classes weekly. Students and classes gained points and rewards for activity in and out of school.Main outcome measuresThe primary outcome was average daily minutes of accelerometer-assessed moderate-to-vigorous physical activity at 10 months post intervention. Secondary outcomes included accelerometer-assessed activity during school, after school and at weekends; self-reported physical activity and psychosocial outcomes; cost-effectiveness; well-being and a mixed-methods process evaluation. Measurement staff were blinded to allocation.ResultsOf 2862 recruited participants, 2167 (76%) attended 10-month follow-up measurements and we analysed the primary outcome for 1874 (65.5%) participants. At 10 months, there was a mean decrease in moderate-to-vigorous physical activity of 8.3 (standard deviation 19.3) minutes in control participants and 10.4 (standard deviation 22.7) minutes in intervention participants (baseline-adjusted difference –1.91 minutes, 95% confidence interval –5.53 to 1.70 minutes; p = 0.316). The programme cost £13 per student compared with control. Therefore, it was not cost-effective. Non-significant indications of differential impacts suggested detrimental effects among boys (boys –3.44, 95% confidence interval –7.42 to 0.54; girls –0.20, 95% confidence interval –3.56 to 3.16), but favoured adolescents from lower socioeconomic backgrounds (medium/low 4.25, 95% confidence interval –0.66 to 9.16; high –2.72, 95% confidence interval –6.33 to 0.89). Mediation analysis did not support the use of any included intervention components to increase physical activity. Some may have potential for improving well-being. Students, teachers and mentors mostly reported enjoying the GoActive intervention (56%, 87% and 50%, respectively), but struggled to conceptualise their roles. Facilitators of implementation included school support, embedding a routine, and mentor and tutor support. Challenges to implementation included having limited school space for activities, time, and uncertainty of teacher and mentor roles.LimitationsRetention on the primary outcome at 10-month follow-up was low (65.5%), but we achieved our intended sample size, with retention comparable to similar trials.ConclusionsA rigorously developed school-based intervention (i.e. GoActive) was not effective in countering the age-related decline in adolescent physical activity. Overall, this mixed-methods evaluation provides transferable insights for future intervention development, implementation and evaluation.Future workInterdisciplinary research is required to understand educational setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale.Trial registrationCurrent Controlled Trials ISRCTN31583496.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 6. See the NIHR Journals Library website for further project information. This work was additionally supported by the Medical Research Council (London, UK) (Unit Programme number MC_UU_12015/7) and undertaken under the auspices of the Centre for Diet and Activity Research (Cambridge, UK), a UK Clinical Research Collaboration Public Health Research Centre of Excellence. Funding from the British Heart Foundation (London, UK), Cancer Research UK (London, UK), Economic and Social Research Council (Swindon, UK), Medical Research Council, the National Institute for Health Research (Southampton, UK) and the Wellcome Trust (London, UK), under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged (087636/Z/08/Z; ES/G007462/1; MR/K023187/1). GoActive facilitator costs were borne by Essex and Cambridgeshire County Councils.

Purpose:To examine adolescent experiences and perspectives of the GoActive intervention (ISRCTN31583496) using mixed methods process evaluation to determine satisfaction with intervention components and interpret adolescents' experiences of the intervention process in order to provide insights for future intervention design. Methods:Participants (n = 1542; 13.2 ± 0.4 years, mean ± SD) provided questionnaire data at baseline (shyness, activity level) and post-intervention (intervention acceptability, satisfaction with components). Between-group differences (boys vs. girls and shy/inactive vs. others) were tested with linear regression models, accounting for school clustering. Data from 16 individual interviews (shy/inactive) and 11 focus groups with 48 participants (mean = 4; range 2-7) were thematically coded. Qualitative and quantitative data were merged in an integrative mixed methods convergence matrix, which denoted convergence and dissonance across datasets. Results:Effect sizes for quantitative results were small and may not represent substantial between-group differences. Boys (vs. girls) preferred class-based sessions (β = 0.2, 95% confidence interval (CI): 0.1-0.3); qualitative data suggested that this was because boys preferred competition, which was supported quantitatively (β = 0.2, 95%CI: 0.1-0.3). Shy/inactive students did not enjoy the competition (β = -0.3, 95%CI: -0.5 to -0.1). Boys enjoyed trying new activities more (β = 0.1, 95%CI: 0.1-0.2); qualitative data indicated a desire to try new activities across all subgroups but identified barriers to choosing unfamiliar activities with self-imposed choice restriction leading to boredom. Qualitative data highlighted critique of mentorship; adolescents liked the idea, but older mentors did not meet expectations. Conclusion:We interpreted adolescent perspectives of intervention components and implementation to provide insights into future complex interventions aimed at increasing young people's physical activity in school-based settings. The intervention component mentorship was liked in principle, but implementation issues undesirably impacted satisfaction; competition was disliked by girls and shy/inactive students. The results highlight the importance of considering gender differences in preference of competition and extensive mentorship training.

Background: Less than 20% of adolescents globally meet recommended levels of physical activity, and not meeting these recommended levels is associated with social disadvantage and rising disease risk. The determinants of physical activity in adolescents are multilevel and poorly understood, but the school’s social environment likely plays an important role. We conducted a cluster randomised controlled trial to assess the effectiveness of a school-based programme (GoActive) to increase moderate-to-vigorous physical activity (MVPA) among adolescents. Methods and findings: Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion. Within participating schools (n = 16), all Year 9 students were eligible and invited to participate. Participants were 2,862 13- to 14-year-olds (84% of eligible students). After baseline assessment, schools were computer-randomised, stratified by school-level pupil premium funding (below/above county-specific median) and county (control: 8 schools, 1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43]). Measurement staff were blinded to allocation. The iteratively developed, feasibility-tested 12-week intervention, aligned with self-determination theory, trained older adolescent mentors and in-class peer-leaders to encourage classes to conduct 2 new weekly activities. Students and classes gained points and rewards for engaging in any activity in or out of school. The primary outcome was average daily minutes of accelerometer-assessed MVPA at 10-month follow-up; a mixed-methods process evaluation evaluated implementation. Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5%). At 10 months, there was a mean (SD) decrease in MVPA of 8.3 (19.3) minutes in the control group and 10.4 (22.7) minutes in the intervention group (baseline-adjusted difference [95% confidence interval] −1.91 minutes [−5.53 to 1.70], p = 0.316). The programme cost £13 per student compared with control; it was not cost-effective. Overall, 62.9% of students and 87.3% of mentors reported that GoActive was fun. Teachers and mentors commented that their roles in programme delivery were unclear. Implementation fidelity was low. The main methodological limitation of this study was the relatively affluent and ethnically homogeneous sample. Conclusions: In this study, we observed that a rigorously developed school-based intervention was no more effective than standard school practice at preventing declines in adolescent physical activity. Interdisciplinary research is required to understand educational-setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale. Trial registration: ISRCTN Registry ISRCTN31583496.

School-based multi-component physical activity (PA) promotion is advocated, however, research has indicated that a multi-component approach may not always be effective at increasing adolescent PA. Evaluation of the GoActive 12-week multi-component school-based intervention showed no effect on adolescent PA. A mixed-methods process evaluation was embedded to facilitate greater understanding of the results, to elicit subgroup perceptions, and to provide insight into contextual factors influencing intervention implementation. This paper presents the reach, recruitment, dose, and fidelity of GoActive, and identifies challenges to implementation. The process evaluation employed questionnaires (1543 Year 9s), individual interviews (16 Year 9s, 7 facilitators, 9 contact teachers), focus groups (48 Year 9s, 58 mentors), alongside GoActive website analytics and researcher observations. GoActive sessions reached 39.4% of Year 9s. Intervention satisfaction was relatively high for mentors (87.3%) and facilitators (85.7%), but lower for Year 9s (59.5%) and teachers (50%). Intervention fidelity was mixed within and between schools. Mentorship was the most implemented component. Factors potentially contributing to low implementation included ambiguity of the roles subgroups played within intervention delivery, Year 9 engagement, institutional support, and further school-level constraints. Multiple challenges and varying contextual considerations hindered the implementation of GoActive in multiple school sites. Methods to overcome contextual challenges to implementation warrant in-depth consideration and innovative approaches.

BackgroundLess than 20% of adolescents globally meet recommended levels of physical activity, and not meeting these recommended levels is associated with social disadvantage and rising disease risk. The determinants of physical activity in adolescents are multilevel and poorly understood, but the school's social environment likely plays an important role. We conducted a cluster randomised controlled trial to assess the effectiveness of a school-based programme (GoActive) to increase moderate-to-vigorous physical activity (MVPA) among adolescents.Methods and findingsNon-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion. Within participating schools (n = 16), all Year 9 students were eligible and invited to participate. Participants were 2,862 13- to 14-year-olds (84% of eligible students). After baseline assessment, schools were computer-randomised, stratified by school-level pupil premium funding (below/above county-specific median) and county (control: 8 schools, 1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43]). Measurement staff were blinded to allocation. The iteratively developed, feasibility-tested 12-week intervention, aligned with self-determination theory, trained older adolescent mentors and in-class peer-leaders to encourage classes to conduct 2 new weekly activities. Students and classes gained points and rewards for engaging in any activity in or out of school. The primary outcome was average daily minutes of accelerometer-assessed MVPA at 10-month follow-up; a mixed-methods process evaluation evaluated implementation. Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5%). At 10 months, there was a mean (SD) decrease in MVPA of 8.3 (19.3) minutes in the control group and 10.4 (22.7) minutes in the intervention group (baseline-adjusted difference [95% confidence interval] -1.91 minutes [-5.53 to 1.70], p = 0.316). The programme cost £13 per student compared with control; it was not cost-effective. Overall, 62.9% of students and 87.3% of mentors reported that GoActive was fun. Teachers and mentors commented that their roles in programme delivery were unclear. Implementation fidelity was low. The main methodological limitation of this study was the relatively affluent and ethnically homogeneous sample.ConclusionsIn this study, we observed that a rigorously developed school-based intervention was no more effective than standard school practice at preventing declines in adolescent physical activity. Interdisciplinary research is required to understand educational-setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale.Trial registrationISRCTN Registry ISRCTN31583496.