Study design and protocol for a mixed methods evaluation of an intervention to reduce and break up sitting time in primary school classrooms in the UK: the CLASS PAL (Physically Active Learning) Programme

Introduction: Children engage in a high volume of sitting in school, particularly in the classroom. A number of strategies, such as physically active lessons (termed movement integration (MI)), have been developed to integrate physical activity into this learning environment; however, no single approach is likely to meet the needs of all pupils and teachers. This protocol outlines an implementation study of a primary school-based MI intervention: CLASS PAL (Physically Active Learning) programme. This study aims to (A) determine the degree of implementation of CLASS PAL, (B) identify processes by which teachers and schools implement CLASS PAL and (C) investigate individual (pupil and teacher) level and school-level characteristics associated with implementation of CLASS PAL. Methods and analysis: The intervention will provide teachers with a professional development workshop and a bespoke teaching resources website. The study will use a single group before-and-after design, strengthened by multiple interim measurements. Six state-funded primary schools will be recruited within Leicestershire, UK. Evaluation data will be collected prior to implementation and at four discrete time points during implementation: At measurement 0 (October 2016), school, teacher and pupil characteristics will be collected. At measurements 0 and 3 (June-July 2017), accelerometry, cognitive functioning, self-reported sitting and classroom engagement data will be collected. At measurements 1(December 2016-March 2017) and 3, teacher interviews (also at measurement 4; September-October 2017) and pupil focus groups will be conducted, and at measurements 1 and 2 (April-May 2017), classroom observations. Implementation will be captured through website analytics and ongoing teacher completed logs. Ethics and dissemination: Ethical approval was obtained through the Loughborough University Human Participants Ethics Sub-Committee (Reference number: R16-P115). Findings will be disseminated via practitioner and/or research journals and to relevant regional and national stakeholders through print and online media and dissemination event(s)

A school-based intervention ('Girls Active') to increase physical activity levels among 11- to 14-year-old girls: cluster RCT

Background: Physical activity (PA) levels among adolescent girls in the UK are low. ‘Girls Active’, developed by the Youth Sport Trust (YST), has been designed to increase girls’ PA levels. Objective: To understand the effectiveness and cost-effectiveness of the Girls Active programme. Design: A two-arm cluster randomised controlled trial. Setting: State secondary schools in the Midlands, UK. Participants: Girls aged between 11 and 14 years. Intervention: Girls Active involves teachers reviewing PA, sport and physical education provision, culture and practices in their school; attending training; creating action plans; and effectively working with girls as peer leaders to influence decision-making and to promote PA to their peers. Support from a hub school and the YST is offered. Main outcome measures: The change in objectively measured moderate to vigorous intensity PA (MVPA) levels at 14 months. Secondary outcomes included changes in overall PA level (mean acceleration), light PA levels, sedentary time, body composition and psychosocial outcomes. Cost-effectiveness and process evaluation (qualitative and quantitative) data were collected. Results: Twenty schools and 1752 pupils were recruited; 1211 participants provided complete primary outcome data at 14 months. No difference was found in mean MVPA level between groups at 14 months [1.7 minutes/day, 95% confidence interval (CI) –0.8 to 4.3 minutes/day], but there was a small difference in mean MVPA level at 7 months (2.4 minutes/day, 95% CI 0.1 to 4.7 minutes/day). Significant differences between groups were found at 7 months, but not at 14 months, in some of the objective secondary outcomes: overall PA level represented by average acceleration (1.39 mg, 95% CI 0.1 to 2.2 mg), after-school sedentary time (–4.7 minutes/day, 95% CI –8.9 to –0.6 minutes/day), overall light PA level (5.7 minutes/day, 95% CI 1.0 to 10.5 minutes/day) and light PA level on school days (4.5 minutes/day, 95% CI 0.25 to 8.75 minutes/day). Minor, yet statistically significant, differences in psychosocial measures at 7 months were found in favour of control schools. Significant differences in self-esteem and identified motivation in favour of intervention schools were found at 7 and 14 months, respectively. Subgroup analyses showed a significant effect of the intervention for those schools with higher numbers of pupils at 14 months. Girls Active was well received by teachers, and they reported that implemented strategies and activities were having a positive impact in schools. Barriers to implementation progress included lack of time, competing priorities and the programme flexibility. Implementation costs ranged from £2054 (£23/pupil) to £8545 (£95/pupil) per school. No differences were found between groups for health-related quality-of-life scores or frequencies, or for costs associated with general practitioner, school nurse and school counsellor use. Conclusions: Girls Active may not have had an effect on the random 90 girls per school included in the evaluation. Although we included a diverse sample of schools, the results may not be generalisable to all schools. Girls Active was viewed positively but teachers did not implement as many aspects of the programme as they wanted. The intervention was unlikely to have a wide impact and did not have an impact on MVPA level at 14 months. Capitalising on the opportunities of a flexible programme like this, while also learning from the stated barriers to and challenges of long-term implementation that teachers face, is a priority for research and practice. Trial registration: Current Controlled Trials ISRCTN10688342. Funding: This 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. 7, No. 5. See the NIHR Journals Library website for further project information. The YST funded the intervention. This study was undertaken in collaboration with the Leicester Clinical Trials Unit, a UK Clinical Research Collaboration-registered clinical trials unit in receipt of NIHR Clinical Trials Unit support funding. Neither the YST nor the NIHR Clinical Trials Unit had any involvement in the Trial Steering Committee, data analysis, data interpretation, data collection or writing of the report. The University of Leicester authors are supported by the NIHR Leicester–Loughborough Biomedical Research Unit (2012–17), the NIHR Leicester Biomedical Research Centre (2017–22) and the Collaboration for Leadership in Applied Health Research and Care East Midlands. These funders had no involvement in the Trial Steering Committee, the data analysis, data interpretation, data collection or writing of the report

Effectiveness of the ‘Girls Active’ school-based physical activity programme:A cluster randomised controlled trial

Abstract Background Globally, adolescent girls’ physical activity (PA) levels are low. The ‘Girls Active’ secondary school-based programme, developed by the Youth Sport Trust, aims to increase PA in adolescent girls. This paper explores the effectiveness of the ‘Girls Active’ school-based PA programme. Methods A random sample of girls aged 11–14 from 20 secondary schools (Midlands, UK) participated in a two-arm cluster randomised controlled trial. Ten schools received Girls Active and 10 continued with usual practice. Measurements were taken at baseline, seven- and 14-month follow-up. Primary outcome: wrist-worn accelerometer measured moderate- to vigorous-intensity PA (MVPA). Secondary outcomes: overall PA, light PA, sedentary time, body composition, and psychosocial outcomes. Generalised estimating equations, adjusted for school cluster and potential confounders, were used and A priori subgroup analysis was undertaken. Micro-costing and cost-consequence analyses were conducted using bespoke collection methods on programme delivery information. Outcomes for the cost-consequence analysis were health related quality of life measured by the Child Health Utility-9D and service use. Results Overall, 1752 pupils participated, 1211 (69.1%) provided valid 14-month accelerometer data. No difference in MVPA (mins/day; 95% confidence intervals) was found at 14 months (1.7; -0.8 to 4.3), there was at seven months (2.4; 0.1 to 4.7). Subgroup analyses showed significant intervention effects on 14-month in larger schools (3.9; 1.39 to 6.09) and in White Europeans (3.1; 0.60 to 6.02) and in early maturers (5.1; 1.69 to 8.48) at seven months. The control group did better in smaller schools at 14-months (-4.38; -7.34 to -1.41). Significant group differences were found in 14-month identified motivation (-0.09; -0.18 to -0.01) and at seven months in: overall PA (1.39 mg/day; 0.1 to 2.2), after-school sedentary time (-4.7; -8.9 to -0.6), whole day (5.7; 1.0 to 10.5) and school day (4.5; 0.25 to 8.75) light PA, self-esteem. Small, statistically significant, differences in some psychosocial variables favoured control schools. Micro-costing demonstrated that delivering the programme resulted in a range of time and financial costs at each school. Cost-consequence analysis demonstrated no effect of the programme for health related quality of life or service use. Conclusions Compared with usual practice, ‘Girls Active’ did not affect 14-month MVPA. Trial registration ISRCTN1068834

Protocol for an implementation evaluation of an intervention to reduce and break-up sitting time in the school classroom: the CLASS PAL (Physically Active Learning) Project

Introduction: Children engage in a high volume of sitting in school, particularly in the classroom. A number of strategies, such as physically active lessons (termed movement integration (MI)), have been developed to integrate physical activity into this learning environment; however, no single approach is likely to meet the needs of all pupils and teachers. This protocol outlines an implementation study of a primary school-based MI intervention: CLASS PAL (Physically Active Learning) programme. This study aims to (A) determine the degree of implementation of CLASS PAL, (B) identify processes by which teachers and schools implement CLASS PAL and (C) investigate individual (pupil and teacher) level and schoollevel characteristics associated with implementation of CLASS PAL. Methods and analysis: The intervention will provide teachers with a professional development workshop and a bespoke teaching resources website. The study will use a single group before-and-after design, strengthened by multiple interim measurements. Six state-funded primary schools will be recruited within Leicestershire, UK. Evaluation data will be collected prior to implementation and at four discrete time points during implementation: At measurement 0 (October 2016), school, teacher and pupil characteristics will be collected. At measurements 0 and 3 (June–July 2017), accelerometry, cognitive functioning, self-reported sitting and classroom engagement data will be collected. At measurements (December 2016–March 2017) and 3 , teacher interviews (also at measurement 4; September–October 2017) and pupil focus groups will be conducted, and at measurements 1 and 2 (April–May 2017), classroom observations. Implementation will be captured through website analytics and ongoing teacher completed logs

A cluster randomised controlled trial to investigate the effectiveness and cost effectiveness of the 'Girls Active' intervention: a study protocol

Background: Despite the health benefits of physical activity, data from the UK suggest that a large proportion of adolescents do not meet the recommended levels of moderate-to-vigorous physical activity (MVPA). This is particularly evident in girls, who are less active than boys across all ages and may display a faster rate of decline in physical activity throughout adolescence. The ‘Girls Active’ intervention has been designed by the Youth Sport Trust to target the lower participation rates observed in adolescent girls. ‘Girls Active’ uses peer leadership and marketing to empower girls to influence decision making in their school, develop as role models and promote physical activity to other girls. Schools are provided with training and resources to review their physical activity, sport and PE provision, culture and practices to ensure they are relevant and attractive to adolescent girls. Methods/Design: This study is a two-arm cluster randomised controlled trial (RCT) aiming to recruit 20 secondary schools. Clusters will be randomised at the school level (stratified by school size and proportion of Black and Minority Ethnic (BME) pupils) to receive either the ‘Girls Active’ intervention or carry on with usual practice (1:1). The 20 secondary schools will be recruited from state secondary schools within the Midlands area. We aim to recruit 80 girls aged 11 –14 years in each school. Data will be collected at three time points; baseline and seven and 14 months after baseline. Our primary aim is to investigate whether ‘Girls Active’ leads to higher objectively measured (GENEActiv) moderate-to-vigorous physical activity in adolescent girls at 14 months after baseline assessment compared to the control group. Secondary outcomes include other objectively measured physical activity variables, adiposity, physical activity-related psychological factors and the cost-effectiveness of the ‘Girls Active’ intervention. A thorough process evaluation will be conducted during the course of the intervention delivery. Discussion: The findings of this study will provide valuable information on whether this type of school-based approach to increasing physical activity in adolescent girls is both effective and cost-effective in the U

Process evaluation of the school-based girls active programme

Background: Girls Active is a physical activity programme, delivered in UK secondary schools, with the aim of increasing moderate-to-vigorous physical activity (MVPA) in girls aged 11-14 years. This study presents the process evaluation as part of a 14-month cluster randomised controlled trial designed to evaluate the effectiveness of the Girls Active programme and which showed no difference in the primary outcome (MVPA at 14 months) between intervention and control arms. Methods: Quantitative and qualitative data were collected from intervention schools over the course of the 14 month trial. Feedback forms and attendance records were completed at the end of all teacher and peer leader training and review days. At 7- and 14-months, semi-structured interviews were conducted with the lead Girls Active teacher in all intervention schools (n = 10) and staff from the intervention provider (n = 4) and hub school (n = 1). At 14 months, separate focus groups with peer leaders (n = 8 schools), girls who participated in the evaluation component of the trial (n = 8 schools), and a sample of boys (n = 6 schools) were conducted. All participants in the intervention schools were asked to complete an exit survey at 14 months. Teachers (intervention and control) completed a school environment questionnaire at baseline, 7- and 14-months. Results: The Girls Active programme, i.e., the training and resources, appeared to be well received by teachers and pupils. Factors that may have contributed to the lack of effectiveness include: some initial uncertainty by teachers as to what to do following the initial training, a predominant focus on support activities (e.g., gathering opinions) rather than actual physical activity provision, and school-level constraints that impeded implementation. Conclusions: Girls Active and what it was trying to achieve was valued by schools. The programme could be improved by providing greater guidance to teachers throughout, the setting of timelines, and providing formal training to peer leaders. Trial registration: ISRCTN, ISRCTN10688342. Registered 12 January 2015

Micro-costing and a cost-consequence analysis of the 'Girls Active' programme : a cluster randomised controlled trial

Physical inactivity has been identified as a leading risk factor for premature mortality globally, and adolescents, in particular, have low physical activity levels. Schools have been identified as a setting to tackle physical inactivity. Economic evidence of school-based physical activity programmes is limited, and the costs of these programmes are not always collected in full. This paper describes a micro-costing and cost-consequence analysis of the 'Girls Active' secondary school-based programme as part of a cluster randomised controlled trial (RCT). Micro-costing and cost-consequence analyses were conducted using bespoke cost diaries and questionnaires to collect programme delivery information. Outcomes for the cost-consequence analysis included health-related quality of life measured by the Child Health Utility-9D (CHU-9D), primary care General Practitioner (GP) and school-based (school nurse and school counsellor) service use as part of a cluster RCT of the 'Girls Active' programme. Overall, 1,752 secondary pupils were recruited and a complete case sample of 997 participants (Intervention n = 570, Control n = 427) was used for the cost-consequence analysis. The micro-costing analysis demonstrated that, depending upon how the programme was delivered, 'Girls Active' costs ranged from £1,054 (£2 per pupil, per school year) to £3,489 (£7 per pupil, per school year). The least costly option was to absorb 'Girls Active' strictly within curriculum hours. The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the 'Girls Active' programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes. This paper provides recommendations for those gathering cost and service use data in school settings to supplement validated and objective measures, furthering economic research in this field

Compliance of Adolescent Girls to Repeated Deployments of Wrist-worn Accelerometers

PURPOSE: To determine the cross-sectional and cumulative compliance of adolescent girls to accelerometer wear at three deployment points and to identify variables associated with compliance. METHODS: Girls from 20 secondary schools were recruited: 10 schools were participating in the 'Girls Active' intervention and 10 were control schools. Physical activity was measured using the GENEActiv accelerometer worn on the non-dominant wrist 24 hours/day for up to 7-days at baseline, 7-months and 14-months. Demographic and anthropometric characteristics were recorded. RESULTS: Seven valid days (≥16 hours) of accelerometer wear were obtained from 83%, 77% and 68% of girls at baseline (n = 1734), 7-months (n = 1381) and 14-months (n = 1326), respectively. 68% provided 7-valid days for both baseline and 7-months, 59% for baseline and 14-months and 52% for all three deployment points. Estimates of physical activity level from 3-days of measurement could be considered equivalent to a 7-day measure (i.e. they fell within a ±5% equivalence zone). Cross-sectionally, 3-valid days were obtained from at least 91% of girls; cumulatively, this was obtained from ≥88% of girls across any two deployment points and 84% of girls across all three deployment points. When controlling for clustering at school level and other potential predictors, physical activity level, being South Asian, being in the intervention group and prior compliance were positively associated with monitor wear. CONCLUSION: Compliance reduced across deployment points, with the reduction increasing as the deployment points got further apart. High prior compliance and high physical activity level were associated with the most additional wear-time

Study design and protocol for a mixed methods evaluation of an intervention to reduce and break up sitting time in primary school classrooms in the UK: The CLASS PAL (Physically Active Learning) Programme.

INTRODUCTION: Children engage in a high volume of sitting in school, particularly in the classroom. A number of strategies, such as physically active lessons (termed movement integration (MI)), have been developed to integrate physical activity into this learning environment; however, no single approach is likely to meet the needs of all pupils and teachers. This protocol outlines an implementation study of a primary school-based MI intervention: CLASS PAL (Physically Active Learning) programme. This study aims to (A) determine the degree of implementation of CLASS PAL, (B) identify processes by which teachers and schools implement CLASS PAL and (C) investigate individual (pupil and teacher) level and school-level characteristics associated with implementation of CLASS PAL. METHODS AND ANALYSIS: The intervention will provide teachers with a professional development workshop and a bespoke teaching resources website. The study will use a single group before-and-after design, strengthened by multiple interim measurements. Six state-funded primary schools will be recruited within Leicestershire, UK.Evaluation data will be collected prior to implementation and at four discrete time points during implementation: At measurement 0 (October 2016), school, teacher and pupil characteristics will be collected. At measurements 0 and 3 (June-July 2017), accelerometry, cognitive functioning, self-reported sitting and classroom engagement data will be collected. At measurements 1(December 2016-March 2017) and 3 , teacher interviews (also at measurement 4; September-October 2017) and pupil focus groups will be conducted, and at measurements 1 and 2 (April-May 2017), classroom observations. Implementation will be captured through website analytics and ongoing teacher completed logs. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Loughborough University Human Participants Ethics Sub-Committee (Reference number: R16-P115). Findings will be disseminated via practitioner and/or research journals and to relevant regional and national stakeholders through print and online media and dissemination event(s)