Ward 2008

Methods	Study design: randomised controlled trial Intervention duration: 6 months Length of follow‐up from baseline: 6 months Differences in baseline characteristics: reported Unit of allocation: childcare service Unit of analysis: childcare service
Participants	Service type: childcare centres Region: North Carolina, USA Demographic/socioeconomic characteristics: not described Inclusion/exclusion criteria: inclusion criteria: current enrolment of 15 to 150 children. Exclusion criteria: services with an open case of abuse or neglect or served only a special population. Number of services randomised: 84 (56 intervention, 26 control, 2 excluded following randomisation) Numbers by trial group: n (controls baseline) = 26 n (controls follow‐up) = 26 n (interventions baseline) = 56 n (interventions follow‐up) = 56 Recruitment: all childcare health consultants working in North Carolina were invited to participate. A convenience sample was selected by recruiting the first 30 childcare health consultants (only 1 per county) who indicated an interest in participation, worked with at least 3 childcare services meeting eligibility requirements, and had not participated in the previous pilot project. Recruitment rate: not reported
Interventions	Number of experimental conditions: 2 (intervention, control) Policies, practices or programmes targeted by the intervention: NAPSACC programme. Best practices for the promotion of proper nutrition and regular physical activity at childcare. The programme focused on 15 nutrition and physical activity areas. Nutrition areas of focus included: fruits and vegetables; fried food and high‐fat meats; beverages; menus and variety; meals and snacks; food items outside of regular meals and snacks; supporting healthful eating; nutrition education for children, parents and staff; and nutrition policy. Key physical activity areas of focus included: active play and inactive time; TV use and TV viewing; play environment; supporting physical activity; physical activity education for children, parents and staff; and physical activity policy Implementation strategies: ‐ Provision of educational materials ‐ Self‐assessment instrument completed by service managers ‐ Action planning to improve at least 3 target areas identified from the self‐assessment ‐ Education workshops on child being overweight, healthy eating and physical activity for children delivered by childcare health consultants ‐ Provision of technical assistance to service staff via in‐person visits and telephone contact ‐ Re‐assessment using the self‐assessment tool Who delivered the intervention: trained childcare health consultants Theoretical underpinning: social cognitive theory against a social‐ecologic framework Description of control: delayed intervention control group
Outcomes	Outcome relating to the implementation of childcare service policies, practices or programmes: ‐ Total nutrition score ‐ Total physical activity score Data collection method: EPAO tool including 1‐day observation and a review of pertinent service documents conducted by trained observers. 75 items were selected to evaluate the impact of the intervention. All 75‐item responses were converted to a 3‐point scale (0, 1 and 2), averaged within a given subscale, and multiplied by10, with the average of all subscale scores representing total nutrition and physical activity scores. Validity of measures used: not established at time of study ‐ additional work tests the reliability and validity of the NAPSACC self‐assessment instrument in a sample of childcare services Outcome relating to staff knowledge, skills or attitudes: not applicable 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	No information provided on the method for generating random sequence for allocation of childcare health consultants to treatment groups.
Allocation concealment (selection bias)	Unclear risk	No information provided on concealment of allocation of childcare health consultants to groups.
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	Outcome assessors were blind to group allocation of services and the tool used was observational.
Incomplete outcome data (attrition bias) All outcomes	Low risk	82 of 84 services recruited were followed up ‐ 2 services were lost to follow‐up due to closure.
Selective reporting (reporting bias)	Unclear risk	Authors state that the outcome measures were determined a priori but unknown if these are listed in a study protocol or trial registry.
Other bias	Unclear risk	—