BackgroundPhysical 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.ObjectiveTo understand the effectiveness and cost-effectiveness of the Girls Active programme.DesignA two-arm cluster randomised controlled trial.SettingState secondary schools in the Midlands, UK.ParticipantsGirls aged between 11 and 14 years.InterventionGirls 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 measuresThe 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.ResultsTwenty 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.ConclusionsGirls 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 registrationCurrent Controlled Trials ISRCTN10688342.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic 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.
Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic