Stookey 2017.

Methods	Study design: Cluster‐RCT Intervention duration: 6 months Length of follow‐up from baseline: 12 months Differences in baseline characteristics: reported Unit of allocation: Childcare service Unit of analysis: Childcare service
Participants	Service type: Childcare service Region: San Francisco, USA Demographic/socioeconomic characteristics: The CCHP provides services to childcare centres that primarily serve low‐income children in San Francisco and do not have federal, state or school district funding. Inclusion/exclusion criteria: All childcare centres that participated in CCHP nutrition screenings in 2011–2012 were eligible for the HAP pilot. Childcare centres that were closed in Autumn 2012 or declined CCHP services for 2012–2013 before the randomisation were ineligible for the HAP pilot. Childcare centres with funding from Head Start, the San Francisco Unified School District, or Community College District were ineligible to receive CCHP screenings, and excluded from the HAP pilot. Number of services randomised: 43 services Numbers by trial group: n (controls baseline) = 24 n (controls follow‐up) = 24 n (interventions baseline) = 19 n (interventions follow‐up) = 19 Recruitment: Service: 45 childcare centres were invited to participate; of these, 43 centres participated. In summer 2012, the SFDPH epidemiologist randomised childcare centres in two blocks, one block for each of two CCHP health workers responsible for BMI screenings. A list of the same length of random, unique, unsorted numbers was generated using randomizer.org. For each health worker, childcare centres had an equal chance of being assigned to CCHP + HAP or CCHP + HAP Delayed. Enrolment in the childcare centres ranged from 14 to 160 children. The mean (SE) enrolment in childcare centres did not vary significantly by treatment assignment (48 (9) vs 37 (4)), and remained stable over time. Child: 902 participants completed data collection at baseline. Of these, 522 were allocated to the intervention arm and 380 participants to the delayed control arm. Recruitment rate: 96%
Interventions	Number of experimental conditions: 2 (intervention, delayed control) Policies, practices or programmes targeted by the intervention: ‐ Use of physical activity curriculum ‐ Staff involvement in active play ‐ Visibility of pitchers of drinking water Implementation strategies: Educational materials: Invitation packet, which included information about the HAP, a self‐assessment for childcare providers, and information about the gift card incentive for completing the self‐assessment Incentives: Gift card incentive for completing the self‐assessment Educational meetings: The San Francisco Children’s Council offered two workshops to address needs identified by the HAP participants. A nutrition workshop addressed ideas for seasonal menu planning, child nutrition education resources for parents, and policies for food for holidays or celebrations. A physical activity workshop addressed how to integrate age‐appropriate physical activity and academic learning for preschoolers. Educational outreach or academic detailing: CCHP public health nurses or health workers introduced the HAP resources and process, in‐person, to childcare centre staff. They delivered the HAP invitation packet to the childcare centre, and spent up to 16 h per childcare centre, providing one‐on‐one support to each childcare provider regarding the HAP self‐assessment, goal setting, action plans to achieve the goal(s), Tip Sheets and online Technical Assistance resources. Tailored interventions: The HAP translated the nutrition and physical activity NAPSACC resources and process into a programme that coordinated self‐assessment and practice improvement across childcare providers. Who delivered the intervention: Childcare centre staff Theoretical underpinning: not reported Description of control: Childcare centres allocated to the CCHP + HAP Delayed group were also offered HAP resources, only after a delay, in 2014–2015. Throughout the evaluation period, routine CCHP services were given to centres allocated to the CCHP + HAP Delayed group. These services included public health nurse consultation, health education, and hearing, vision, dental, and nutrition screenings and referrals.
Outcomes	Outcome relating to the implementation of childcare service policies, practices or programmes: Exposure to the 3 nutrition and physical activity centre index practices: Data collection method: The health workers gathered information about 3 practices which were relevant for tracking changes in response to HAP workshops that were offered in 2013. Data regarding the 3 index practices were combined into a score to track and compare cumulative changes in these practices in all CCHP + HAP and CCHP + HAP Delayed centres. Validity of measures used: not reported Outcome relating to cost: not applicable Outcome relating to adverse consequences: not applicable Outcome relating to child diet, physical activity or weight status: Change in child BMI percentile at the child level and childcare centre level: Data collection method: CCHP health workers visited all childcare centres that requested bi‐annual BMI screenings in the autumn and spring of each academic year. The health workers recorded child age and sex, and measured child weight and height using a standardised protocol and calibrated instruments. Measurements were taken after the child removed outer layers of clothing and shoes. The age and sex‐specific BMI percentile and BMI z‐score for each child was calculated relative to the CDC 2000 growth reference using Epi Info 7 software. The change in BMI percentile was calculated. Incident cases of overweight or obesity were identified. Validity of measures used: not reported Outcome relating to implementation strategy acceptability, adoption, penetration, sustainability and appropriateness: Penetration: Data collection method: Collected by the San Francisco Children’s Council Healthy Apple Program Coordinator, including number of childcare centres that completed the HAP self‐assessment(s), set goals, received technical assistance materials, attended workshops, improved best practices, and received a HAP award. Validity of measures used: not reported
Notes	The HAP development in 2011–2012 was funded by a CDC Community Transformation Grant. Funding for the HAP pilot evaluation was provided by the Feeling Good Project, funded by USDA SNAP‐Ed, an equal opportunity provider and employer (Laura Brainin‐Rodriguez, Coordinator).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A list of random, unique, unsorted numbers was generated using randomizer.org.
Allocation concealment (selection bias)	Low risk	Eligible childcare centres were listed in alphabetical order and a list of random numbers generated.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Outcome: 3 index practices (use of physical activity curriculum; staff usually joining in physical active play with children; pitchers of drinking water visible in the classroom). The healthcare workers and childcare providers were not blinded to treatment allocation, therefore, there was a high risk of performance bias.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome: 3 index practices (use of physical activity curriculum; staff usually joining in physical active play with children; pitchers of drinking water visible in the classroom). The healthcare workers and childcare providers were not blinded to treatment allocation, therefore, there was a high risk of detection bias.
Incomplete outcome data (attrition bias) All outcomes	Low risk	At the 2‐year follow‐up, 9 (4 in intervention, 5 in comparison) of the 43 centres had missing data (21% attrition). Low risk of attrition bias
Selective reporting (reporting bias)	Unclear risk	There was no study protocol, therefore, it was unclear if there was selective outcome reporting.
Recruitment to cluster	Low risk	All parents/children were invited to participate.
Baseline imbalance	Unclear risk	Some baseline imbalances, but unknown whether these biased outcome. CCHP + HAP centres served significantly older children than CCHP + HAP Delayed centres in 2011–2012 and 2012–2013. The CCHP + HAP centres had a significantly smaller prevalence of overweight or obesity at autumn enrolment, compared to CCHP + HAP Delayed centres, in the baseline year (2011–2012). Intervention centres also had on average more children enrolled per centre than control centres (i.e. difference in size).
Loss of clusters	Low risk	Low risk of loss of clusters ‐ similar % of centres lost across groups
Incorrect analysis	Low risk	The intracluster correlation coefficient (ICC), measure of within‐childcare center variance relative to between‐childcare center variance, was estimated to describe clustering in the outcome data in the follow‐up year and implementation year 2.
Compatibility with individually randomised RCTs	Unclear risk	No evidence to make assessment