Harrington 2018.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: all state (government‐funded) secondary schools in Leicester City, Leicestershire, and Rutland, UK, with a Key Stage 3 (students age 11 to 14 years), and state schools that were geographically close to Leicester City, Leicestershire, and Rutland but in neighbouring counties School exclusion criteria: — Student inclusion criteria: girls between the ages of 11 and 14 years and in Years 7, 8, and 9 Student exclusion criteria: — Setting: school Age group: children/adolescents Gender distribution: females Country where trial was performed: UK
Interventions	Intervention: Girls Active, a support framework for schools to review and change their PA, PE, and school sport culture and practices with support of the Youth Sport Trust and a hub school to develop a school action plan. Core components include submission of self‐review and action plans; attendance of lead teacher at initial training; use of package of resources or use of an alternative; engagement of young people as peer leaders; use of online, in‐person, or phone support of hub and/or development coach; lead teacher attendance at peer review day; and submission of mission analysis. Schools were provided with two £500 capacity funding instalments to coincide with action plan submission Comparator: schools were not given any specific guidance or advice and were assumed to carry on with their usual practice of PE and sport provision Duration of intervention: 14 months Duration of follow‐up: 14 months Number of schools: 20 Theoretical framework: social cognitive theory
Outcomes	PA participation PA duration Sedentary time BMI Health‐related quality of life
Study registration	ISRCTN10688342
Publication details	Language of publication: English Funding: non‐commercial funding (research funding body) Publication status: peer‐reviewed journal
Stated aim for study	"The aim of this study was to assess the effectiveness of the Girls Active PA programme in UK secondary schools"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote from publication: "sequentially numbered sections within a folder were used to implement the group allocations"
Allocation concealment (selection bias)	Low risk	Quote from publication: "following baseline measurements, schools were randomised by an independent statistician. The investigator team were not aware of the sequence until after randomisation"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote from publication: "the trial statistician was not blinded"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote from publication: "measurement team members, except the team lead for the day, were blinded to group randomisation"
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	High risk	Comment: only per protocol utilised; large missing data from control schools Quote from publication: "the per protocol population included schools that engaged with 70% of the seven core components (as detailed above) of the programme over the 14 months and had complete data for the analysis concerned on ‘by analysis’ basis. In the control arm, the per protocol population included all schools/pupils randomised to that arm"
Incomplete outcome data (attrition bias) Physical activity and sedentary time	High risk	Comment: only per protocol utilised; large missing data from control schools Quote from publication: "the per protocol population included schools that engaged with 70% of the seven core components (as detailed above) of the programme over the 14 months and had complete data for the analysis concerned on ‘by analysis’ basis. In the control arm, the per protocol population included all schools/pupils randomised to that arm"
Selective reporting (reporting bias)	Low risk	Comment: all outcomes in trial registry reported
Cluster RCT ‐ Recruitment bias	Low risk	Quote from publication: "randomisation will occur after baseline assessments and will be carried out by the Leicester Clinical Trials Unit"
Cluster RCT ‐ Baseline imbalance	Low risk	Comment: baseline differences at cluster level accounted for Quote from publication: "generalized estimating equations, accounting for school level clustering, and adjusting for baseline MVPA, stratification factors of school size (< 850, ≥ 850) and percent of non‐White pupils (< 20%, ≥ 20%), percent free school meals and participant year group, were employed"
Cluster RCT ‐ Loss of clusters	High risk	Comment: 2 control schools lost to follow‐up
Cluster RCT ‐ Incorrect analysis	Low risk	Quote from publication: "generalized estimating equations, accounting for school level clustering, and adjusting for baseline MVPA, stratification factors of school size (< 850, ≥ 850) and percent of non‐White pupils (< 20%, ≥ 20%), percent free school meals and participant year group, were employed"