Fitzgibbon 2006.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 14 weeks Unit of allocation: school Unit of analysis: child
Participants	Service type: centre‐based (Head Start) Operation: not reported Country (region): USA (Chicago) Country income classification: high Low‐SES sample: yes Population description: predominantly Latino centres Inclusion criteria: all children were eligible to participate in the intervention. Exclusion criteria: not reported Number of services randomised: 12 (6 intervention, 6 control) Number of children randomised: 401 (202 intervention, 199 control) Characteristics Children Age: Intervention: 50.8 months (SD 7.3) Control: 51.0 months (SD 7.0) Gender (% female): Intervention: 47.5% Control: 51.3% Ethnicity: Intervention: black: 15.8%; Latino: 73.3%; multiracial/other: 10.9% Control: black: 6.5%; Latino: 89.4%; multiracial/other: 4% Parents Age (years): Intervention: 31.5 (SD 8.6) Control: 30.7 (SD 7.2) Gender (% female): 100% Ethnicity: not reported Parent/family SES: Female parent years of education Intervention: 11.3 (SD 3.6) Control: 10.6 (SD 3.7) Method of recruitment: not reported Missing data/dropout: retention rate at post‐intervention was 97% Reasons for dropout: not reported Characteristics of dropouts: not reported
Interventions	Programme name: Hip‐Hop to Health Jr Number of conditions: 1 intervention, 1 control Intervention duration: 14 weeks Intervention setting: ECEC and home Intervention strategies: Health curriculum Children Education: a diet/physical activity curriculum delivered by trained ECEC educators 3 x/week. Each session included 20 min of nutrition activity based on hand puppets that reflected the food pyramid. Ethos and environment Children Exposure: 20 min of aerobic activity led by trained ECEC educators 3 x/week All participants Cultural: the programme was culturally proficient, tailored to a Latinx population and delivered in both Spanish and English. Partnerships Families Resources: parents received weekly newsletters and accompanying homework assignments designed to be an interactive activity between parents and children. Incentive: a small monetary incentive was provided for completed homework. Intensity of intervention: 40‐min lessons, 3 times/week for children for 14 weeks; 12 x weekly newsletters, weekly homework assignments for parents Intervention delivered by: ECEC staff Modality: face‐to‐face, written Theoretical basis: Social Cognitive Theory and Self‐Determination Theory Description of control: alternative intervention control (covered general health concepts such as seat belt safety, immunisation, and dental health)
Outcomes	Outcomes relating to child dietary intake: Total fat, saturated fatty acids, fibre Number of participants analysed: Intervention baseline: 188 Intervention follow‐up: 178 Control baseline: 174 Control follow‐up: 156 Data collection measure: partial or full recall by parent Data collector: researcher (parent provided information to researcher) Validity of measures used: not reported Outcomes relating to child physical measures: Weight, BMI, BMI z‐score Number of participants analysed: Intervention baseline: 202 Intervention follow‐up: 196 Control baseline: 199 Control follow‐up: 187 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: Study authors state only, "No adverse events reported during the trial for any participants" Number of participants analysed: not reported Data collection measure: not reported Data collector: not reported Validity of measures used: not reported
Notes	Funding source: National Heart, Lung, and Blood Institute (Grant HL 58871)
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) Diet outcomes	High risk	We assumed that due to the nature of the intervention, ECEC service staff and study personnel delivering the intervention were not blind to the study allocation. The outcome is likely to be influenced by lack of blinding.
Blinding of participants and personnel (performance bias) Physical outcomes	Low risk	We assumed that due to the nature of the intervention, ECEC service staff and study personnel delivering the intervention were not blind to the study allocation. However, the outcome is not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Diet outcomes	High risk	Parents reported children's dietary intake. Blinding of parents not reported, and the outcome measurement is 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 and were not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Diet outcomes	High risk	Data were available for 178 (88%) participants in the intervention group and 156 (78%) students in the control group at post‐intervention. Due to the magnitude of missing data and difference in the proportions of participants followed up between groups, the risk of bias was assessed as high.
Incomplete outcome data (attrition bias) Physical outcomes	Low risk	Data were available for 196 (97%) participants in the intervention group and 187 (94%) students in the control group at post‐intervention. There were no significant differences in retention rates between intervention and control groups. Study authors stated that “The primary analytic approach was ITT, with all participants completing follow‐ups included in the condition to which they were assigned.” Therefore, risk of attrition bias was considered to be low.
Selective reporting (reporting bias)	Unclear risk	Only 24‐h recall results were published in the study, yet prior publication mentions diet observation and FFQ
Recruitment bias	Unclear risk	Baseline data collection occurred after randomisation of schools, however it is unclear whether individual recruitment occurred before or after randomisation.
Baseline imbalance	High risk	Study authors report baseline imbalance that is not accounted for in the analysis
Loss of clusters	Low risk	No apparent loss of clusters
Incorrect analysis	Low risk	Study authors stated that "Proc Mixed was used, with the individual school as the unit of randomization, yielding a test statistic with 10 df for 12 schools."
Contamination	Unclear risk	No evidence to make assessment
Other bias	Low risk	No clear other source of bias