Sutherland 2016.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: government and Catholic schools; schools with post codes ranked in the bottom 50% of New South Wales post codes based on the Socio‐Economic Indexes for Australia; between 120 and 200 Year 7 students (to meet sample size requirements); and not participating in other major PA or health intervention studies School exclusion criteria: — Student inclusion criteria: all Year 7 students in participating schools will be eligible to participate in the study measurement Student exclusion criteria: classes catering for students with severe physical and mental disabilities will be excluded Setting: school Age group: adolescents Gender distribution: females and males Country/Countries where trial was performed: Australia
Interventions	Intervention: intervention involved implementation of 7 PA intervention strategies and 6 strategies to support implementation of the intervention. PA intervention strategies included: teaching strategies to maximise students’ PA in health and PE lessons; development and monitoring of student PA plans within PE lessons; enhanced school sport program; development or modification of school policies; PA programmes during school break; promotion of community PA providers; and parent engagement The intervention implementation strategies included in‐school PA consultant (change agent) establishing leadership and support teacher training school resources teacher prompts intervention implementation performance feedback Comparator: schools allocated to control group participated in measurement components of the trial only and delivered PA teaching and promotion practices according to PE curriculum and school‐based initiatives Duration of intervention: 24 months Duration of follow‐up: 24 months Number of schools: 10 Theoretical framework: socioecological theory and health‐promoting schools framework
Outcomes	PA duration BMI
Study registration	ACTRN12612000382875
Publication details	Language of publication: English Funding: non‐commercial funding (governmental organisation) Publication status: peer‐reviewed journal
Stated aim for study	"The aim of this study is to determine whether a multi‐component PA intervention implemented in disadvantaged secondary schools can reduce the decline in PA associated with adolescence"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: block randomisation using random numbers function
Allocation concealment (selection bias)	Low risk	Comment: independent statistician conducted randomisation after data were collected
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: participants not blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: data were collected by trained research assistants blind to group allocation
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	Low risk	Quote from publication: "2 sensitivity analyses were conducted, first using only those that provided complete adiposity outcomes at all 3 time points (complete cases), and second using multiple imputation to fill in the missing data. The multiple imputation model used the method of chained regression equations, including variables that were prognostic of missing data and additional demographic and outcome data to create 5 imputed data sets. The results from fitting the model were pooled over the 5 data sets using Rubin’s method"
Incomplete outcome data (attrition bias) Physical activity and sedentary time	Low risk	Quote from publication:  "PA outcome data were analysed assuming data were “missing at random.” Sensitivity analyses were undertaken for the primary outcome, initially adjusting for any variables on which students with and without 24‐month follow‐up accelerometer data were significantly different, and secondly, using multiple imputation"
Selective reporting (reporting bias)	Low risk	Comment: all outcomes in protocol reported
Cluster RCT ‐ Recruitment bias	Low risk	Comment: randomisation occurred after baseline data collected
Cluster RCT ‐ Baseline imbalance	Unclear risk	Comment: did not assess
Cluster RCT ‐ Loss of clusters	Low risk	Comment: no clusters lost
Cluster RCT ‐ Incorrect analysis	Low risk	Quote from publication: "a 3‐level hierarchical model was used to capture correlations in the data with random intercepts for repeated measures on individuals clustered within schools"