Natale 2014a.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 3 months Unit of allocation: centre Unit of analysis: child
Participants	Service type: centre‐based Operation: subsidised Country (region): USA (Miami‐Dade County, Florida) Country income classification: high Low‐SES sample: yes Population description: Miami‐Dade County, Florida, is one of the only counties in the USA that is 'minority majority': 64% of its residents identify as Hispanic, and 20% as African American. Over 51% of its 2.3 million residents were born outside the USA (138 countries identified). Nearly a quarter of the population is younger than 18 years, > 15% of the school‐aged population has limited English proficiency (Spanish and Haitian Creole as their primary languages), the graduation rate is only 45%, and 22% of young adults have limited literacy skills. Rates of obesity are higher among ethnic‐minority children in Miami‐Dade County, compared with ethnic‐minority children nationally (31% vs 26%, respectively). In addition, there are more than 1400 child‐care centres in the county serving over 20,000 children; 18% live below the poverty line. Inclusion criteria: centres' study inclusion criteria consisted of (a) serve > 30 children, (b) serve low‐income children, and (c) ethnic make‐up had to be reflective of the county as a whole (minority majority). Low income was determined based on whether or not the child received subsidised child care. Exclusion criteria: not reported Number of services randomised: 8 (6 intervention, 2 control) Number of children randomised: 307 (238 intervention, 69 control) Characteristics Children Age: Intervention: 2 years: 14.3%; 3 years: 35.7%; 4 years: 36.6%; 5 years: 13.5% Control: 2 years: 29%; 3 years: 33.3%; 4 years: 31.9%; 5 years: 5.8% Gender (% female): Intervention: 49.2% Control: 47.8% Ethnicity: Intervention: Hispanic/other: 35.7%; Hispanic/Cuban: 24%; African American: 19.3%; Hispanic/Puerto Rican: 3.8%; Haitian: 1.3%; Hispanic/Mexican: 2.1%; other Caribbean black: 2.5%; white: 0.8%; other: 4.2%; unknown: 6.3% Control: Hispanic/other: 20.3%; Hispanic/Cuban: 27.5%; African American: 30.4%; Hispanic/Puerto Rican: 1.5%; Haitian: 7.5%; Hispanic/Mexican: 1.4%; other Caribbean black: 0%; white: 4.4%; other: 1.5%; unknown: 5.8% Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported Method of recruitment: all participants were recruited at the child‐care centre. Parents were approached during drop‐off or pick‐up times. Missing data/dropout: attrition rates were calculated based on available data for child BMI as well as parent measures for each of the time points. At baseline, there were 318 child and parent dyads; at 6 months, there were 239 child and parent dyads; and at 1 year, there were 185 parent and child dyads Reasons for dropout: not reported Characteristics of dropouts: not reported
Interventions	Programme name: Healthy Inside ‐ Healthy Outside (HI‐HO) program Number of conditions: 1 intervention, 1 control Intervention duration: 6 months Intervention setting: ECEC and home  Intervention strategies: Health curriculum Children Education: the 6‐month intervention presented a developmentally, culturally, and linguistically appropriate curriculum that targets preschoolers.  Ethos and environment ECEC staff Training: 2 x training sessions. Teachers and staff were trained on the role and rationale of the Hip Hop to Health Jr. programme, taught implementation strategies, and provided lessons to use with the children. Support: weekly technical assistance visits with the teachers and a Hip Hop to Health specialist to ensure the implementation of a low‐fat, high‐fibre diet that included more fruits and vegetables with an emphasis on cultural barriers.  Service Policy: the development of policies to increase physical activity and healthy eating Menu modification: a nutritionist worked with each ECEC centre to modify menus to improve the health profile, make them compliant with the policies, and also to ensure that the USDA nutritional requirements were met.  All participants Cultural: the programme was designed to be culturally sensitive, given the ethnic diversity of the families, teachers, and administrators and staff at participating schools.  Partnerships Families  Education: the parent curriculum was modelled after a modified version of the Eating Right Is Basic and Hip‐Hop to Health Jr. programmes. Monthly educational dinner in which nutrition and physical activity were discussed. Sessions were provided by registered dietitians who were of the same cultural background as the parents. Resources: monthly newsletters, and at‐home activities. For each of the 6 x at‐home activities that each family completed, they received a healthy snack bag. At the end of the programme, parents who attended ≥ 3 dinners received a certificate of completion.  Healthcare Delivery: a nutritionist assisted centres in menu modification.  Intensity of intervention: Teacher component: 2 x training sessions/centre; monthly educational parent dinner; monthly parent newsletters; monthly at‐home activities; each centre agreed on a drink policy; a snack policy and physical activity policy.  Intervention delivered by: research team, ECEC staff, healthcare staff Modality: face‐to‐face, written Theoretical basis: Socio‐Ecological Model Framework Description of control: alternative intervention control (safety education)
Outcomes	Outcomes relating to child dietary intake: not reported Outcomes relating to child anthropometric measures: Weight z‐score, BMI z‐score Number of participants analysed: not reported Data collection measure: objectively measured (CDC) Data collector: researcher Validity of measures used: not reported Outcome relating to child language and cognitive performance: not reported Outcome relating to child social/emotional measures: not reported Outcome relating to child quality of life: not reported Outcome relating to cost: not reported Outcome relating to adverse consequences: not reported
Notes	Funding source: Miami‐Dade County Children’s Trust (grant number 764‐287)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The random sequence generation procedure was not described.
Allocation concealment (selection bias)	Unclear risk	No information on the method of allocation concealment reported
Blinding of participants and personnel (performance bias) Physical outcomes	Low risk	No clear blinding of participants and personnel to study allocation, however the outcome is not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Physical outcomes	Low risk	Blinding not reported, however children's height and weight were measured by the research assistants and are not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Physical outcomes	High risk	Data were available for 239 (75%) of child‐parent dyads at 6‐month follow‐up and 185 (58%) dyads at 1‐year follow‐up. Distribution of loss not provided, and reasons for loss not reported. Due to the magnitude of missing data over the short‐term and long‐term follow‐up, the risk of bias was assessed as high.
Selective reporting (reporting bias)	Unclear risk	No prospective trial protocol or trial registration so it was unclear whether there was selective outcome reporting
Recruitment bias	Unclear risk	It is unclear whether individuals were recruited to the study before or after randomisation of clusters.
Baseline imbalance	Unclear risk	Differences noted, however there is no report on whether these were statistically significant. Models included age in months, race, and gender as potential confounders. Ethnicity was not controlled for in the models yet there appears to be baseline differences between groups.
Loss of clusters	High risk	Study authors stated that there was an "unexpected closure of a control centre." There were only 2 control centres, so this may be a large proportion of controls.
Incorrect analysis	High risk	There was no accounting for clustering of children within centres.
Contamination	Unclear risk	No evidence to make assessment
Other bias	Unclear risk	No conflict of interest statement was reported.