Benjamin 2007

Methods	Study design: cluster‐randomised controlled trial (counties randomly allocated into either the intervention (n = 6) or comparison (n = 2) group; all eligible services were approached and services enrolled on a first‐come first‐served basis) Intervention duration: 6 months Length of follow‐up from baseline: approximately 10 months (assessments occurred 4 months after the 6‐month intervention) Differences in baseline characteristics: not reported Unit of allocation: county Unit of analysis: childcare service
Participants	Service type: childcare centres Region: North Carolina, USA Demographic/socioeconomic characteristics: not reported Inclusion/exclusion criteria: inclusion criteria: size of the childcare service (between 20 and 150 children); participation in the Child and Adult Care Food Program; rating of 3, 4 or 5 stars on the NC1‐5 Star Rating System for quality child care. Exclusion criteria: open case of child abuse or neglect; service provided services to a special population of children only; Head Start service; classified as a family child care home Number of services randomised: 19 (15 intervention, 4 control) Numbers by trial group: n (control baseline) = 4 n (control follow‐up) = 4 n (intervention baseline) = 15 (2 intervention services withdrew because their manager had left their position) n (intervention follow‐up) = 13 Recruitment: convenience sampling – the North Carolina childcare regulatory agency provided a list of eligible childcare services for each intervention and comparison county. 2 services were selected per county, except for 1 large county where 5 services participated. Recruitment rate: not reported
Interventions	Number of experimental conditions: 2 (intervention, control) Policies, practices or programmes targeted by the intervention: NAPSACC programme. 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: ‐ Self‐assessment: childcare service managers, with assistance from key service staff, completed the self‐assessment instrument to identify current service nutrition and physical activity policies and practices ‐ Action plan: NAPSACC trained childcare health consultants worked with the services to develop an action plan to improve at least 3 areas identified from the self‐assessment instrument. Childcare service managers were asked to select their priority areas for improvement in order to facilitate the most fitting and lasting environmental changes at the service. ‐ Workshops: the trained childcare health consultants delivered 3 x 30‐minute workshops on being overweight, healthful eating and physical activity ‐ Provision of technical assistance: ongoing technical assistance (visits and calls) were provided by the childcare health consultants to service managers to support policy and practice changes Who delivered the intervention: NAPSACC trained childcare health consultants Theoretical underpinning: NAPSACC is a theory‐based programme that employs components of social cognitive theory against a backdrop of the socio‐ecological framework. The inherent relationship between environment and behaviour has proven useful in intervention research. Social cognitive theory identifies several factors that influence behaviour change, including expectancies, observational learning, self‐efficacy, behavioural capability, reinforcement and reciprocal determinism, which were all principles used to guide the NAPSACC intervention. Description of control: the comparison services did not receive any training or technical assistance from a childcare health consultant but completed only the pre‐ and post‐self‐assessment instrument.
Outcomes	Outcome relating to the implementation of childcare service policies, practices or programmes: Total nutrition and physical activity score assessed using the self‐assessment instrument, which included 29 nutrition and 15 physical activity questions with either a demonstrated or a perceived relationship to childhood overweight. Each question had 3 response categories, assigned 1, 2 or 3 points (1 = minimum standard, 2 = good, 3 = best practice) Data collection method: self‐assessment instrument 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	Given the small sample size (n = 4) in the comparison group, no between‐group comparisons were made
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Counties were matched and randomly allocated to control or intervention groups. The sequence generation procedure is not described.
Allocation concealment (selection bias)	Unclear risk	Unclear as to whether concealment of allocation occurred.
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	Self‐assessment conducted by childcare service staff for nutrition and physical activity policies and practices. No blinding of research personnel or participants (service managers) and due to the self‐report of this outcome the risk of bias is considered high.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	17 of the 19 intervention group services had full data available and 4 of 4 control services. No information is provided on the characteristics of the services that dropped out, nor sensitivity analysis undertaken to test assumptions regarding missing data.
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	Unclear risk	All services within the county invited to participate and chosen to participate on first‐come basis – 2 per county, but 1 county was given permission to have 5 services participate.
Baseline imbalance	Unclear risk	A convenience sample of 6 intervention and 2 comparison counties, matched on urban/rural status randomly allocated to intervention or comparison group. Unclear if baseline characteristic imbalances are present as this was not reported. Outcome measures at baseline were similar.
Loss of clusters	Unclear risk	Unclear whether the 2 lost services were from the same county.
Incorrect analysis	High risk	No statistical analysis completed due to small sample size.
Compatibility with individually randomised RCTs	Unclear risk	Unable to determine if a herd effect exists.
Other bias	Unclear risk	—