Natale 2021.

Study characteristics
Methods	Study design: cluster‐RCT (this study reported on a comparison of 2 RCTs that included different samples. As Phase 1 (RCT 1) is reported in Natale 2014b, only Phase 2 (RCT 2) is reported for Natale 2021 (i.e. treated as a singular RCT) Length of follow‐up from baseline: 10 months Unit of allocation: centre Unit of analysis: centre
Participants	Service type: centre‐based Operation: not reported Country (region): USA (Miami‐Dade County) Country income classification: high Low‐SES sample: yes Population description: low resource, predominantly ethnic minority families Inclusion criteria: ECEC centres must have met the following criteria to be included in the study: (1) have > 50 children enrolled who are 18‐66 months in age, (2) serve low‐income families (i.e. the child meets state eligibility as receiving school readiness funds), (3) reflect the ethnic diversity of the MDC Public School System (63% Hispanic, 19% non‐Hispanic black, and 18% non‐Hispanic white), and (4) obtain agreement from child‐care centre directors and teachers to participate. Exclusion criteria: ECEC centres were excluded if they did not meet the inclusion criteria and if they had a high prevalence of special needs children (i.e. a child with a diagnosed disability with an Individual Education Plan). Special needs did not include children with food allergies and sensitivities; these children were included if their parent consented to study participation. Children who brought their own meals because of diet restrictions and those who were identified by parents on the demographic form as failure to thrive were also excluded. Number of services randomised: 24 (12 intervention, 12 control) Number of children randomised: 825 (465 intervention, 360 control) Characteristics Children Age: 43.4 months (SD 13.3) Gender (% female): 52.5% Ethnicity: Hispanic Cuban: 20.5%; other Hispanic: 43.5%; non‐Hispanic black: 25.2%; non‐Hispanic white: 4.9%; other: 5.8% Parents Age (years): 18‐24: 6.9%; 25‐30: 21.1%; 31‐40: 30.1%; 41‐50: 6.7%; 51+: 1.5%; missing: 33.8% Gender (% female): unclear Ethnicity: not reported Parent/family SES: < 12th grade or GED: 5.3%; completed high school: 7.1%; completed education > high school: 66.6%; missing: 31.4% Method of recruitment: centre directors and teachers were invited to attend a project orientation describing the activities at their centres. Parents/guardians were recruited for participation in the study via verbal announcements, flyers, and letters sent home. Family members who returned a signed interest form were contacted by telephone. Missing data/dropout: not reported Reasons for dropout: not reported Characteristics of dropouts: not reported
Interventions	Programme name: Healthy Caregivers‐Healthy Children Phase 2 Number of conditions: 1 intervention, 1 controls Intervention duration: 2 school years (approximately 10 months ) Intervention setting: ECEC Intervention strategies: Health curriculum Children Education: the child curriculum had lesson plans for instructional needs that were consistent with the policies outlined in the toolkit (3 plans focus on beverage/snack policies and 3 plans focus on physical activity/screen‐time policies). Consisted of physical activities and health‐orientated messages incorporated into everyday activities. Ethos and environment ECEC staff Support: monthly technical assistance Curriculum: role modelling curriculum delivered via train‐the trainer model Service Materials/Policy: The Health Caregivers Healthy Children toolkit consists of material designed to incorporate all current nutrition and physical activity policy requirements for preschool children in Florida and embrace best‐practice guidelines (snack policy, beverage policy, physical activity policy, and screen‐time policy). Partnerships Parents Workshops: 6 monthly role modelling workshops the University of Florida Institute of Food and Agricultural Sciences Extension Family Nutrition Program staff Intensity of intervention: 6 x 3‐h monthly workshops for teachers; 6 monthly role‐modelling workshops for parents; child lesson plans (frequency and duration not reported) Intervention delivered by: research team, ECEC staff, healthcare staff Modality: face‐to‐face, written Theoretical basis: Reach Effective Adoption Implementation and Maintenance Framework, Social Cognitive Theory and Adult Learning Theory Description of control: alternative intervention control (safety education)
Outcomes	Outcomes relating to child dietary intake: Vegetable intake, fruit intake, fried intake, fast food intake, snack food intake, soda intake Number of participants analysed: Intervention baseline: 465 Intervention follow‐up: 465 Control baseline: 360 Control follow‐up: 360 Data collection measure: Healthy Kids Checklist Data collector: parent/caregiver Validity of measures used: validated Outcomes relating to child physical measures: BMI percentile, healthy BMI percentile, unhealthy BMI percentile Number of participants analysed: Intervention baseline: 465 Intervention follow‐up: 465 Control baseline: 360 Control follow‐up: 360 Data collection measure: objectively measured (US Health and Human Services (HHS) guidelines) 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: The USDA NRI/AFRI (grant numbers #2009‐05065 and #2014‐08403) and National Institutes of Health (F31DK116533)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A total of 24 ECEC centres were randomly assigned (via a random number table) to 1 of 2 study arms.
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, child‐care 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 via questionnaire. Blinding of parents was not possible 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	Unclear risk	The number of children available at follow‐up is not reported. Risk of attrition bias is unclear.
Incomplete outcome data (attrition bias) Physical outcomes	Unclear risk	The number of children available at follow‐up is not reported. Risk of attrition bias is unclear.
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	High risk	There was a statistically significant difference between the intervention group and the control group for child race/ethnicity, child age, caregiver age, caregiver relationship to child, caregiver language spoken in home, caregiver level of education, and birthplace of caregiver.
Loss of clusters	Unclear risk	Not reported
Incorrect analysis	Low risk	Study authors stated that "All models also accounted for clustering of students within centers."
Contamination	Unclear risk	No evidence to make assessment
Other bias	Low risk	No clear other source of bias