Saraf 2015.

Study characteristics
Methods	Trial name: no trial name Study design: cluster‐RCT Intervention duration: intervention started in April 2009 and continued until December 2009. Length of follow‐up from baseline: baseline data were collected from December 2008 to February 2009. The postintervention assessment was carried out in January and February 2010. Differences in baseline characteristics: there were no significant differences between the intervention and the control group in the student population at baseline. Unit of allocation: region Unit of analysis: school
Participants	School type: middle schools Region: villages of Ballabgarh Block of Haryana state, India Recruitment: 40 schools were invited to participate. For the purpose of randomisation, all villages predominantly on the left side of Mohna Road (the main road passing through all the villages) were considered 1 group and those on the right side another group. 1 group was allocated as intervention, and the other as control based on draw of lots. Schools: at school level, verbal consent was taken from the school administrator. Students: at student level, written consent was taken from the parents by sending the consent form to the students before administering the questionnaire. Students present at the time of school visit with a written consent from parents were included and those absent on the day of visit were excluded from the study. There were 1026 students in the intervention and 1322 students in control group. Demographic/socioeconomic characteristics: mean age of the study population was 12.5 (SD 1.08) years in the intervention group and 12.3 (SD 1.11) years in the control group (P = 0.08). There were 47 % girls in the intervention group and 46 % girls in the control group (P = 0.6). Inclusion/exclusion criteria School level inclusion:no criteria reported. Students level inclusion:present at the time of school visit with a written consent from parents were included and those absent on the day of visit were excluded from the study. Number of schools allocated: 40 (19 intervention, 21 control) Numbers by trial group n (controls baseline) = 21 n (controls follow‐up) = 21 n (interventions baseline) = 19 n (interventions follow‐up) = 19
Interventions	Number of experimental conditions: 2 (1 intervention, 1 control) Policies, practices or programmes targeted by the intervention The intervention consisted of a school component (policies), a classroom component (activities) and a family component (Information Education & Communication (IEC) material). Implementation strategies EPOC: local consensus processes ‐ Initially a sensitisation meeting was conducted to sensitise the school administrators; a short film on non‐communicable diseases and their risk factors was shown in addition to baseline results. The meeting aimed to conclude with assured support from the school administrators and formation of school health committee. ‐ The intervention had 3 components: a school component, a classroom component and a family/community component. The school component aimed to create enabling environments in the schools by the following. EPOC: local opinion leaders ‐ Formation of school health committee. EPOC: tailored interventions ‐ Formulation of school action plan. EPOC: educational materials ‐ Improving school environment by display of posters and bulletin. EPOC: educational games ‐ Improving school environment by conducting quiz competitions, sports competitions and cultural activities based on non‐communicable diseases. ‐ The classroom component aimed to involve students in health‐promoting activities. EPOC: educational meetings ‐ Health education lectures, flash film, peer group discussions, flip charts, physical training classes. Family/community component: to reach out to the families and community through schools, including the following. EPOC: other ‐ Families were engaged via holiday assignments, school rally, distribution of pamphlets, list of healthy foods, and family orientation about non‐communicable diseases during parent/teacher meetings and annual functions. Theoretical underpinning: it was reported that the intervention was not based on any theoretical model. Description of control: not reported but assume usual practice.
Outcomes	Outcome relating to the implementation of school policies, practices or programmes ‐ Schools having tobacco policy ‐ Policy about PA ‐ School food policy ‐ Mean of fried foods ‐ Mean of salted snacks ‐ Mean of healthy foods Data collection methods: measured using a school check list. The information was gathered from school authorities and by direct observation. Validity of measures used: not reported; however, the methods contained objective and non‐objective components. Outcome relating to cost: not reported Outcome relating to adverse consequences: not reported Outcome relating to child diet, PA or weight status: leisure time MVPA, time watching TV, consumption of fruit, vegetables, deep‐fried foods, salted snacks, purchasing 'eatables' from outside and smoking status. Data collection method: student survey Validity of measures used: not reported
Notes	Research funding: India Institute of Medical Sciences, New Delhi. Conflicts of interest: authors reported no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	All villages predominantly on the left side of the main road passing through all the villages were considered 1 group and those on the right side another group. 1 group was allocated as intervention, and the other as control based on draw of lots.
Allocation concealment (selection bias)	Unclear risk	No information provided about allocation concealment and, therefore, it was unclear if allocation was concealed.
Blinding of participants and personnel (performance bias) Implementation outcome	High risk	Outcome group: all. No blinding or incomplete blinding, and the outcome was likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Implementation outcome	High risk	Outcome group: school check‐list. The information was gathered from school authorities and by direct observation. No blinding of outcome assessment, and the outcome measurement was likely to be influenced by lack of blinding; self‐report considered high risk. Outcome group: all other outcomes High: collected using self‐report.
Incomplete outcome data (attrition bias) Implementation outcome	Low risk	Outcome group: school check‐list/all outcomes. No missing outcome data at school‐level and, therefore, low risk of attrition bias.
Selective reporting (reporting bias)	Unclear risk	No study protocol, therefore, it was unclear if there was selective outcome reporting.
Other bias	Unclear risk	Unclear if it was at risk of contamination. Did not appear at risk of other biases.
Recruitment to cluster	Low risk	Randomisation postrecruitment and baseline data collection.
Baseline imbalance	Unclear risk	School‐baseline characteristics not reported, Arbitrary zone boundary used to create groups and unclear if systematic differences existed between‐group areas although balance between government and private schools relatively even in both groups.
Loss of cluster	Low risk	No loss of clusters.
Incorrect analysis	High risk	Unit of analysis error for the primary trial implementation outcome.
Compatibility with individually randomised RCTs	Unclear risk	Unable to determine if a herd effect existed.
Overall risk of bias assessment	Unclear risk	Most domains were at unclear risk of bias.