Hardy 2010

Methods	Study design: cluster‐randomised controlled trial Intervention duration: 5 months Length of follow‐up from baseline: 5 months Differences in baseline characteristics: reported Unit of allocation: childcare service Unit of analysis: childcare service (staff knowledge and attitudes were assessed at the level of the individual)
Participants	Service type: preschools Region: Sydney, New South Wales, Australia Demographic/socioeconomic characteristics: not described Inclusion/exclusion criteria: inclusion criteria: preschools operating under the auspices of the New South Wales Department of Education and Training located in the Sydney, Western Sydney and South Western Sydney education regions of New South Wales Number of services randomised: 29 (15 intervention, 14 control) Numbers by trial group: n (controls baseline) = 14 n (controls follow‐up) = 14 n (interventions baseline) = 15 n (interventions follow‐up) = 15 Recruitment: all eligible preschools were invited to participate in the study (n = 61) Recruitment rate: 48%
Interventions	Number of experimental conditions: 2 (intervention, control) Policies, practices or programmes targeted by the intervention: 'Munch and Move' programme: ‐ Healthy eating and ways of incorporating food‐based activities into the education programme ‐ Physical activity and ways of incorporating fun, games‐based skills activities into the programme ‐ Strategies to encourage children to limit their recreational screen time ‐ Providing opportunities for children to engage in unstructured physically active play ‐ Developing and implementing healthy nutrition and physical activity fundraising policies Implementation strategies: ‐ 1‐day professional development workshop for up to 2 staff, delivered by a specialised early childhood training organisation ‐ Resources for preschools that included a manual and a small grant to support staff to attend training or purchase physical activity equipment for the service ‐ Contact with health promotion professionals from the local health service, to provide additional advice to preschools to support the delivery of the programme including 2 visits post‐workshop Who delivered the intervention: experts and health service staff Theoretical underpinning: not reported Description of control: control preschools received health information on unrelated topics (road safety and sun safety) during the intervention period
Outcomes	Outcome relating to the implementation of childcare service policies, practices or programmes: ‐ Structured play time (minutes per session) ‐ Frequency of structured play (sessions per week) ‐ Unstructured play time (minutes per session) ‐ Frequency of unstructured play (sessions per week) ‐ Fundamental movement skill activities (minutes per session) ‐ Frequency of fundamental movement skill activities (sessions per week) ‐ Conduct of food‐based activities ‐ Rules concerning food and drink brought in from home ‐ Food policies ‐ Communicating food rules and policies to parents Data collection method: interview with the service manager Validity of measures used: unclear Outcome relating to staff knowledge, skills or attitudes: Knowledge of recommended guidelines for children: ‐ Daily serves of fruit ‐ Daily serves of vegetables ‐ Recreational screen time (TV/DVDs) (hours per day) Attitudes (agreement with statement): ‐ Teachers do not need to act as role models for being active ‐ It is not the role of the teacher to teach movement skills ‐ It is not important that children participate in structured active play ‐ Safety concerns limit active play opportunities in the preschool setting ‐ It is not the role of the teacher to teach about healthy eating ‐ Parents should be able to send any type of food to school with their child ‐ It is alright to sell chocolates and sweets for fundraising Data collection method: childcare service staff self‐report via questionnaire Validity of measures used: unclear Outcome relating to cost: not applicable Outcome relating to adverse consequences: not applicable Outcome relating to child diet, physical activity or weight status: not applicable
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The procedure for random sequence generation was not described.
Allocation concealment (selection bias)	Unclear risk	Whether pending allocation was concealed is unclear as no information is provided on concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	We assumed that due to the nature of the intervention childcare service staff and study personnel delivering the intervention were not blind to the study allocation and therefore there is a potential high risk of performance bias.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Policies and practices ‐ self‐reported by service managers in interviews with research staff, therefore high risk of bias due to managers being aware of allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All service managers followed up in both groups ‐ therefore low risk of bias for outcome regarding implementation of policies and practices.
Selective reporting (reporting bias)	Unclear risk	No prospective trial protocol or trial registration so it is unclear whether there was selective outcome reporting.
Recruitment to cluster	Low risk	All parents of participating services were invited to allow their children to participate.
Baseline imbalance	Unclear risk	Unclear response rate of children in each group – imbalance in numbers of students (intervention 263, control 167); some imbalances in baseline characteristics (mean years teaching experience: intervention 4.5 years, control 6 years; teacher’s aide: intervention 11.1 years, control 8.9 years; children attending 2 days per week: intervention 22%, control 11%; children attending 3 days per week: intervention 21%, control 42%; English speaking: intervention 58%, control 41%) – unknown if any were significant. Adjustment of some characteristics in analysis.
Loss of clusters	Low risk	No loss of clusters.
Incorrect analysis	Low risk	CSPlan procedure used to allow for clustering within service class.
Compatibility with individually randomised RCTs	Unclear risk	Unable to determine if a herd effect exists.
Other bias	Unclear risk	—