Gans 2022.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 8 months Unit of allocation: family child‐care homes (i.e. family day care) Unit of analysis: child
Participants	Service type: family child‐care homes Operation: not reported Country (region): USA (Rhode Island and Massachusetts) Country income classification: high Low‐SES sample: yes Population description: Rhode Island (RI) is a state where approximately 16% of the population identifies as Hispanic or Latinx, at least 40% of family child‐care providers are Spanish speaking. Inclusion criteria: family child‐care providers had to meet the following criteria: have a family day care within 60 miles of Providence, Rhode Island in operation for at least 6 months; be able to read and speak Spanish or English; have a working phone; care for at least 1 unrelated 2–5 year‐old child for 10 h or more/week who ate at least 1 meal and snack/d at the family child‐care home and, family child‐care providers could not plan to close their service for > 3 consecutive weeks during the year following their enrolment in the study. Exclusion criteria: not reported Number of services randomised: unclear Number of children randomised: 119 (60 intervention, 59 control) Characteristics Children Age: 41.7 months (SD 12.0) Gender (% female): 50% Ethnicity: Ethnicity: Latinx: 55%, non‐Latinx: 43, missing: 2% Race: white: 46%, black: 10%, Asian: 1%, American Indian: 1%, Native Hawaiian: 1%, other/> 1 race: 39%, missing: 3% Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported ECEC staff Age (years): 48.86 (SD 8.96) Gender (% female): 100% Ethnicity: Ethnicity: Hispanic: 67.2%; non‐Hispanic: 32.8% Race: white: 2.6%; NA/NA/NP/PI (not defined): 19%; mixed race: 24.1%; declined or missing: 54.3% Service/ECEC staff SES: household income < USD 25,000: 12.6%; USD 25,001‐USD 50,000: 47.9%, USD 50,001‐USD 75,000: 20.2%; USD 75,001‐USD 100,000: 10.1%; ≥ USD 100,001: 5.9%; missing: 3.4% Method of recruitment: recruitment, enrolment and baseline assessment was conducted on a rolling basis from 2015‐2018. A variety of recruitment strategies were used including: (1) information sessions at community organisations that provide training and support for family child‐care providers. These organisations also offered recruitment flyers and brochures to family child‐care providers; (2) meetings with the co‐ordinators of family child‐care provider systems who then emailed study information to family child‐care providers in their systems; (3) presentations at local family child‐care providers' conferences; (4) direct mailings followed by staff phone calls to licensed family child‐care providers whose contact information was publicly available through state databases in Rhode Island, and Massachusetts; and (5) word of mouth referrals from family child‐care providers already participating in the study. Missing data/dropout: 168 family child‐care providers completed the baseline survey, 126 completed the in‐person survey/baseline visit and consented to enrol, and 120 completed the 2‐d baseline observations. Of those, 1 family child‐care provider withdrew after baseline measurement but before randomisation. A total of 423 parents of eligible children consented for their children to be observed and/or measured; 377 of those children had at least 1 measurement; 370 children had their meals observed; 349 had accelerometer measurement, and 327 had anthropometric measurements. Reasons for dropout: reasons for dropout included: did not have kids 2‐5 in home to observe at follow‐up, did not want home observation, withdrew from study and loss of contact. Characteristics of dropouts: not reported
Interventions	Programme name: Healthy Start‑Comienzos Sanos Number of conditions: 1 intervention, 1 control Intervention duration: 8 months Intervention setting: family child‐care home Intervention strategies: Ethos and environment ECEC staff Resources: monthly materials (a report, newsletters and videos (via DVD or emailed video link) in English or Spanish) tailored to the topic chosen by the family child‐care provider Feedback and support: monthly support from a support coach trained in brief motivational interviewing. First, the coach reviewed with the family child‐care provider in person, an individually tailored written feedback report that indicated whether the provider met or did not meet best practices for nutrition, physical activity and screen‐time topics (based on baseline data). Motivational interviewing: the coach then conducted brief motivational interview with the family child‐care provider. At the end of the session, the family child‐care provider selected 1 topic to work on. Monthly calls using motivational interviewing were completed following this. Meetings: in‐person group meetings led by the support coach were also held every 6 weeks in a central public location (e.g. library or church). All participating family child‐care providers were invited to attend these meetings to support one another, discuss challenges and successes, learn a new activity, and share a meal. Service Resources: a set of active toys (e.g. hula hoops, tunnel, bean bags, soft balls) with accompanying activity cards and video clips with ideas for using the toys. Partnerships External provider Delivery: a support coach delivered the intervention. Intensity of intervention: 8 x monthly staff meetings; 8 x monthly staff resources; staff group meetings every 6 weeks Intervention delivered by: healthcare staff Modality: face‐to‐face, telephone, online, written Theoretical basis: Social ecological framework, Social Cognitive Theory, Self Determination Theory Description of control: alternative intervention (covered reading readiness and early literacy skills)
Outcomes	Outcomes relating to child dietary intake: Diet quality (total fruit, whole fruit, total vegetable, greens and beans, whole grains, total dairy, total protein, seafood and plant protein, fatty acids, refined grains, sodium, added sugar, saturated fats) Number of participants analysed: Intervention baseline: 187 Intervention follow‐up: 187 Control baseline: 190 Control follow‐up: 190 Data collection measure: Dietary Observation in Child Care Data collector: researchers Validity of measures used: validated Outcomes relating to child physical measures: 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: this project was funded by the National Heart Lung and Blood Institute, Grant # NIH ‐ R01HL123016. The funding body had no role in the design of the study and collection, analysis, and interpretation of data nor in writing the manuscript.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Study authors state that services were "randomized into either the intervention or comparison group in matched pairs based on primary language spoken and number of age eligible children in their family childcare homes using a Microsoft Excel randomization function."
Allocation concealment (selection bias)	Low risk	Study authors state "Once family childcare home providers completed all baseline measures, they were randomized into either the intervention or comparison group in matched pairs".
Blinding of participants and personnel (performance bias) Diet outcomes	High risk	Study authors state that "Because the days of observation were announced, it is possible that family child care providers changed their behavior on the occasions of having observers in their home, although this would likely have affected both experimental groups." However, providers were informed of their study allocation by the project co‐ordinator. The outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Diet outcomes	Low risk	Evaluation staff were not informed of the intervention group assignment. Study authors state that "we did not measure whether blinding of observers was successfully achieved. However, the field staff were not told the experimental group of family child care provider they observed. Toys that were provided did not have any project identifying information on them, so should not have unblinded experimental group status. In addition, the observers were trained not to have conversations with providers except to clarify information about recipes or ingredients."
Incomplete outcome data (attrition bias) Diet outcomes	Unclear risk	Data were available for 370/423 (87%) of children overall, 42/60 (70%) services in the intervention group, and 47/59 (80%) services in the control group. Study authors state that "Family child care providers and children who completed follow‐up were similar to those who were lost to follow‐up, suggesting that attrition did not overly bias the sample." Reasons for service dropout were provided, however it is unclear whether missing outcome data were related to the true outcome.
Selective reporting (reporting bias)	Low risk	The outcomes reported in the paper were prespecified in the protocol paper.
Recruitment bias	Low risk	Individual recruitment occurred prior to service randomisation
Baseline imbalance	Low risk	Baseline analysis was conducted and there were no significant differences between groups for age, sex, race, ethnicity, or other demographic variables for children or family child‐care provider.
Loss of clusters	Unclear risk	30% of clusters were lost in the intervention group and 20% of clusters lost in the control group. Study authors state that "there was no differential dropout between experimental groups, therefore we did not include imputation of missing values in the analyses." It is unclear whether this loss of clusters introduced bias.
Incorrect analysis	Low risk	Study authors state that "Generalized Estimating Equations (GEE) with robust standard errors were used to model HEI [Healthy Eating Index] scores and physical activity over time. A working independence correlation structure was used to correct for dependency of observations within family child care providers."
Contamination	Unclear risk	No evidence to make assessment
Other bias	Low risk	No clear other source of bias