Finch 2014

Methods	Study design: cluster‐randomised controlled trial Intervention duration: 7 months Length of follow‐up from baseline: 8 months Differences in baseline characteristics: reported Unit of allocation: childcare service Unit of analysis: childcare service (child physical activity was assessed at the level of the individual)
Participants	Service type: centre‐based long daycare services Region: Hunter region, New South Wales Demographic/socioeconomic characteristics: the Hunter region encompasses non‐metropolitan ‘major cities’ and ‘inner regional’ areas with 14,061 children aged 3 to 5 years residing in the area. 5% of residents speak languages other than English and 2% of residents are of Aboriginal or Torres Strait Islander origin. The Hunter region has lower indices of socioeconomic status than the New South Wales state average. Inclusion/exclusion criteria: inclusion criteria: centre‐based long daycare services (providing care for a minimum of 8 hours a day). Services were required to have at least 25 enrolled children aged between 3 to 5 years. Children aged 3 to 5 years attending participating services were eligible for the study if they attended on the day of the week nominated by the service manager for baseline data collection. Number of services randomised: 20 services (10 intervention (242 children), 10 control (215 children) Numbers by trial group: n (controls baseline) = 10 services n (controls follow‐up) = 10 services n (interventions baseline) = 10 services n (interventions follow‐up) = 10 services Recruitment: a total of 70 childcare services in the study region served as the sampling frame Recruitment rate: 54%
Interventions	Number of experimental conditions: 2 (intervention, control) Policies, practices or programmes targeted by the intervention: ‐ Fundamental movement skill development activity sessions ‐ Staff delivery of structured physical activity ‐ Staff role modelling of active play and delivery of verbal prompts ‐ Limiting small screen recreation and sedentary time ‐ Providing children with a physical activity‐promoting indoor and outdoor physical environment ‐ Physical activity policy Implementation strategies: ‐ Staff training (6‐hour workshop for childcare service staff) ‐ Provision of resources ‐ Follow‐up support (2 telephone support calls and a 2‐hour service visit) ‐ Performance feedback via project newsletter on 2 occasions ‐ Incentives ‐ Opinion leaders Who delivered the intervention: workshop and follow‐up component delivered by experts Theoretical underpinning: the multi‐level intervention was designed using the social ecological models of health behaviour change Description of control: wait list control group that did not receive the intervention or any intervention support or materials during the study period and were offered the intervention after collection of all follow‐up data
Outcomes	Outcome relating to the implementation of childcare service policies, practices or programmes: ‐ Fundamental movement skill development activity sessions ‐ Staff delivery of structured physical activity ‐ Staff role modelling of active play and delivery of verbal prompts ‐ Limiting small screen recreation and sedentary time ‐ Physical activity‐promoting resources and materials ‐ Portable equipment ‐ Physical activity policy Data collection method: observational audit ‐ EPAO was conducted by 2 trained research staff Validity of measures used: unclear – EPAO has reported high inter‐observer agreement but other psychometric properties of this tool are not reported Outcome relating to staff knowledge, skills or attitudes: not applicable Outcome relating to cost: not applicable Outcome relating to adverse consequences: The number of child injuries recorded at the service in the month of data collection at baseline and follow‐up Data collection method: service manager self‐report via interview Validity of measures used: unclear Outcome relating to child diet, physical activity or weight status: Child step count: Data collection method: pedometer worn for 1 day during attendance at the childcare service Validity of measures used: a valid measure of physical activity in preschool age children
Notes	The trial had multiple outcomes but did not appear to adjust the P value for multiple comparisons
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised random number function in Microsoft Excel was used to generate random number sequence.
Allocation concealment (selection bias)	Low risk	Statistician not involved in the project allocated the services to groups using a computerised program.
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	Low risk	Implementation of policies and practices measured using observational audit ‐ research staff undertaking audits were blind to group allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Implementation of policies and practices ‐ no loss to follow‐up (10 intervention services; 10 control services).
Selective reporting (reporting bias)	Low risk	There are no unreported outcomes according to those planned in the published protocol.
Recruitment to cluster	Low risk	For the child physical activity measure, children were recruited by service managers at the service selecting a day of the week for measurement to occur. Allocation was not revealed to services until after baseline data collection.
Baseline imbalance	High risk	Baseline imbalance in services in areas of higher socio‐economic status (intervention 90%, control 60%) and average years of operation (intervention 8 years, control 20 years) and no mention of adjustment within analysis.
Loss of clusters	Low risk	100% followed up.
Incorrect analysis	Low risk	Generalised linear mixed model accounting for children nested within services.
Compatibility with individually randomised RCTs	Unclear risk	Unable to determine if a herd effect exists.
Other bias	Unclear risk	—