Waters 2017.

Study characteristics
Methods	Trial name: Fun n healthy in Moreland! Study design: cluster‐RCT. Repeated cross‐sectional design for the collection and analysis of quantitative data. Intervention duration: 5‐year programme with 3.5‐year intervention period Length of follow‐up from baseline: baseline (2004–2005), midway (2007) and completion (2009). Differences in baseline characteristics: at baseline there were no observed differences between trial arms in the proportion of children with overseas‐born mothers, but the intervention arm had higher levels of maternal education, smaller family size and fewer possessing a healthcare card. At follow‐up there were no observed differences between trial arms in maternal or paternal education or the proportion of children with Australian‐born mothers. Smaller differences in family size, healthcare card and family employment status remained. At school level, the intervention arm had more schools from the religious sector and a smaller mean school size. Unit of allocation: schools were randomised using computer‐generated random numbers to either actively engage with the Fun n Healthy in Moreland! programme (intervention arm) or continue with normal school activities and programmes for healthy eating and PA (comparison arm). Unit of analysis Implementation outcomes: school Behavioural/health outcomes: child
Participants	School type: primary schools, children aged 5–12 years Region: Moreland, Victoria, Australia Demographics/socioeconomic characteristics: the City of Moreland, a local government municipality (population of 135,205 in 2006) is located 8.5 km northwest of the central business district of Melbourne, in South Eastern Australia. Of the 31 Melbourne municipalities, this area ranked seventh in social disadvantage at the time of the study. Inclusion/exclusion criteria Inclusion Schools were eligible to participate in the study if they were located in the Moreland municipality and exclusively covered the primary (elementary) school‐aged group, aged 4–13 years (n = 36 schools). Exclusion:not reported Number of schools allocated Schools:24 schools (12 intervention, 12 control) Students:3222 students (1628 control, 1594 intervention) Numbers by trial group n (controls baseline) = 11 schools, 1588 students n (controls follow‐up) = 10 schools, 1460 students n (interventions baseline) = 12 schools, 1579 students n (interventions follow‐up) = 12 schools, 1346 students Recruitment Schools:all 37 school principals of primary schools in the Moreland municipality were contacted by telephone by the Research Project Manager (LGi) and invited to participate in the study. Students:all children attending the consenting schools and their parent/guardian were invited to participate. Recruitment rate Schools:65% Students:recruitment/consent rate within schools was 38.6–64.3%.
Interventions	Number of experimental conditions: 2 (1 intervention, 1 control) Policies, practices or programmes targeted by the intervention ‐ Programme to focus on increasing fruit, vegetable and water consumption, increasing PA and encouraging positive self‐esteem in children not explicitly stated. ‐ Policies targeted within the intervention included canteen policy, PA policy and nutrition policy. Implementation strategies EPOC: tailored interventions Customised development of intervention programme strategies. Theoretical underpinning ‐ Of the evidence‐based intervention/policy/practice or programme: not reported ‐ Of the implementation strategy: the design and implementation of the intervention was underpinned by the World Health Organization Health Promoting Schools Framework. Description of control: continue with normal school activities and programmes for healthy eating and PA (comparison arm).
Outcomes	Outcome relating to the implementation of school policies, practices or programmes Implementation of PA and healthy eating practices directed at students, parents and staff. Data collection method Schools were asked to indicate if they had a written policy relating to PA and the canteen. As part of the intervention process, many of the schools chose to expand their canteen policy to include a broader school‐wide healthy eating policy to include strategies such as healthy fundraising, drink water policies and replacement of confectionery as in‐class rewards. School reported audit of the school food and PA environment, including PA facilities, canteen and fundraising policies and practices. Observational measure used was SOPLAY (System for Observing Play and Leisure Activity in Youth) based on momentary time sampling techniques using systematic and periodic scans of individuals and contextual factors within predetermined target areas. The instrument permits comparison of PA levels in different play environments. Validity of measures used: SOPLAY was validated. Other measures were not reported. Outcome relating to cost ‐ Costing of the resources invested in the intervention, including the Community Development Workers salaries, school resources and parent expenses was also undertaken. ‐ Cost of changes to school environment: not reported ‐ Data collection: process evaluation using monitoring maps, photos and audits to track and record changes in school plans, policies and environment, stability of changes, costs of changes, and level of independence from the research team. ‐ Validity not reported Outcome relating to adverse consequences ‐ Child quality of life: not reported ‐ Data collection: child‐report through child questionnaire of quality of life using the 10‐item version of the international self‐reported measure of quality of life, KidScreen. ‐ Validity: assumed to be valid measure, not reported though. Outcome relating to child diet, PA or weight status ‐ Child anthropometry (i.e. BMI z‐score and waist circumference) (primary) ‐ Fruit and vegetable intake and sweet drink consumption (secondary) ‐ Participation in PA and sedentary behaviour (secondary) Data collection method ‐ BMI z‐score calculated using direct measure of child height and weight to generate BMI, and then z‐scores against the World Health Organization reference curves. Project staff were trained in standardised child height and weight measurement, and a process developed that was sensitive, confidential and avoided value judgements. Weight in light clothing without shoes was recorded to the nearest 0.1 kg. ‐ Using digital scales and height to the nearest 0.5 cm using rigid stadiometers. All measures were taken twice and the mean value used. Where 2 readings differed by > 0.4 kg or 4 cm, a third reading was taken and the 2 closest values used to calculate the mean. ‐ Height and weight measured. ‐ Child and parent report though questionnaire assessing food behaviours and family food habits, respectively, lunch box audit and 24‐hour food record. ‐ Child and parent report of PA/sedentary behaviour. Validity of measures used: not reported
Notes	Research funding: Victorian State Government as part of the Go For Your Life Campaign. The collaboration of schools. Conflicts of interest: authors CA and MT were employed by Merri Community Health Services at the time of the study. The authors had no other financial or non‐financial competing interests to declare.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Schools were randomised using computer‐generated random numbers to either the intervention or comparison arm. The randomisation allocator was blind to school status.
Allocation concealment (selection bias)	Low risk	Participants could not foresee blinding given randomisation was computer generated and conducted by a blind allocator.
Blinding of participants and personnel (performance bias) Implementation outcome	High risk	Outcome group: implementation, student PA and diet. The nature of the study precluded blinding. Outcome: child BMI Low: objectively measured.
Blinding of outcome assessment (detection bias) Implementation outcome	High risk	Outcome group: implementation outcome, child PA and diet High: likely principals knew the outcome of interest given they were asked directly about it and were not blind to allocation. Outcome group: school audit and BMI Low: given it is objective data
Incomplete outcome data (attrition bias) Implementation outcome	Low risk	Outcome group: school audits. Data appeared available for all schools. Outcome: BMI Low: loss to follow‐up even across groups and < 10%. ITT analysis used.
Selective reporting (reporting bias)	Unclear risk	Protocol registered. Unclear as there were additional outcomes in this manuscript that were not reported in the protocol registration (i.e. principal reported barriers and facilitator).
Other bias	Unclear risk	May have been at risk of contamination.
Recruitment to cluster	High risk	Baseline data collection occurred prior to randomisation; however, they re‐consented at each data point for follow‐up evaluations.
Baseline imbalance	High risk	Baseline imbalance appeared to exist. There are also imbalances in the follow‐up groups. At baseline there were no observed differences between trial arms in the proportion of children with overseas‐born mothers, but the intervention arm had higher levels of maternal education, smaller family size and fewer possessing a healthcare card. At follow‐up, there were no observed differences between trial arms in maternal or paternal education or the proportion of children with Australian‐born mothers. Smaller differences in family size, healthcare card and family employment status remained. At school level, the intervention arm had more schools from the religious sector and a smaller mean school size.
Loss of cluster	High risk	Loss of 2 schools (from comparison group) by the completing of follow‐up.
Incorrect analysis	Low risk	School data were presented as proportions. Descriptive statistical analyses of school policies, environments and practices were undertaken using school questionnaire data.
Compatibility with individually randomised RCTs	Unclear risk	Unclear, no statement regarding this.
Overall risk of bias assessment	High risk	Most domains were at high risk of bias.