Healthy Start: Family Childcare Providers and Parents

Not Applicable

Not yet recruiting

• Conditions: Child Obesity; Nutrition, Healthy

• Registration Number: NCT06978270
• Lead Sponsor: Brown University

Brief Summary

The preschool years are a critical time for shaping food preferences and eating behaviors, which affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease, and other chronic conditions. Unfortunately, many US children, especially low-income and ethnic minorities, have dietary patterns associated with obesity and increased morbidity. Thus, to improve child diet quality, it is essential to develop effective targeted interventions in settings where children (especially higher-risk children) spend time. The investigators build upon our efficacious Healthy Start intervention with family childcare home (FCCH) providers (FCCP) to pilot a novel, 8-month multilevel tailored intervention to reach families through FCCH. This would be the first study to incorporate family-based intervention components into FCCH. The 8-month intervention will include an adapted version of the Healthy Start intervention as well as FCCP training to deliver nutrition messages to parents using an existing childcare App, complemented with FCCH environmental cues and tailored print and videos for parents. In sum, feasible and effective interventions to improve young children's diets are urgently needed. The FCCH is a novel and untapped setting to intervene with both FCCP and parents simultaneously to affect children's diets in both childcare and home settings, which has the potential to more fully impact the child's overall diet and weight status.

Detailed Description

The preschool years are a critical time for shaping food preferences and eating behaviors which, in turn, affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease and other chronic conditions. Unfortunately, many US children, especially low-income and ethnic minorities, have dietary patterns associated with obesity and increased morbidity. Thus, to improve child diet quality, it is essential to develop effective targeted interventions in settings where children (especially higher risk children) spend time. There is a national call for dietary interventions that span multiple settings including the childcare and home environments. In response to PAS-20-160, the investigators build upon our efficacious Healthy Start intervention with family childcare home (FCCH) providers (FCCP) to pilot a novel, 8-month multilevel tailored intervention to reach families through FCCH. This would be the first study to incorporate family-based intervention components into FCCH. FCCH are a promising intervention setting as parents trust FCCPs as extended family members and FCCP feel comfortable talking to parents about children's diet, but want more training to do so effectively. The 8-month intervention will include an adapted version of the Healthy Start intervention for English and Spanish-speaking FCCP as well as FCCP training to deliver nutrition messages to parents using an existing childcare App, complemented with FCCH environmental cues and tailored print and videos for parents. Specific Aims are to: SA.1. Conduct formative research with FCCP and parents to inform refinement of the multi-level intervention. SA.2. Conduct a pilot trial with 40 FCCP and 80 parents with 18-54-month-old children to evaluate feasibility and acceptability of intervention and study protocols, and preliminary efficacy of the nutrition intervention compared to an attention-matched control on: a). children's dietary quality at FCCH and home, b). social/physical FCCH and home food environments, c). children's dermal carotenoid levels and z-BMI scores. SA3. Conduct post qualitative interviews with parents, FCCP, coaches, staff \& partners to assess the intervention's acceptability and suggestions for improvement. In sum, feasible and effective interventions to improve young children's diets are urgently needed. The FCCH is a novel and untapped setting to intervene with both FCCP and parents simultaneously to affect children's diets in both the childcare and home settings, which has the potential to more fully impact the child's overall diet and weight status. This pilot feasibility research of a novel, multi-level intervention will inform a future full-scale cluster RCT, which will fill important research gaps and move the frontier of nutrition research forward.

Study Timeline

• Study First Submitted: 2025-03-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-06-15
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• English and Spanish-speaking family childcare providers who care for 18-54 month-old children, Must be state-licensed FCCP, read and speak English/Spanish, plan for FCCH to be in operation for the next year, willingness to be randomized to either study arm, have at least 2 eligible children in their care with at least 1 parent-child dyad consenting to participate, and not have participated in Healthy Start.

Exclusion Criteria

• Not meeting above criteria.

Parents

Inclusion Criteria:

• English and Spanish-speaking legal guardian of children 18-54 months-old who receive care in a participating FCCH for at least 15 hrs./wk., plan to continue childcare with their current FCCP for the next 9 months, are the caregiver mainly responsible for the child's eating at home, and are willing to be randomized to either study arm.

Exclusion Criteria:

• Not meeting above criteria.

Children

Inclusion Criteria:

• Children 18-54 months-old who receive care in a participating FCCH for at least 15 hours per week and who agree to be measured. (All other evaluation is observation that does not require assent).

Exclusion Criteria:

• Not meeting above criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility Score	9 Months	Feasibility Score Recruitment and retention success will be measured and scored. Higher scores will indicate higher recruitment and retention.
Acceptability Score	9 months	Acceptability Score Participant providers and parents rate the intervention as acceptable, which will be coded as a score. Higher score will indicate higher acceptability of the intervention.
Child diet at home	Baseline and 9 months	HEI Score - Diet Quality at Home Parents will be called on two randomly selected days (at least one weekend day) and asked to recall child's food intake in previous 24-hours using gold standard multiple-pass method. Parents will report child's foods and beverage intake on the previous day (excluding child intake while outside their care) using established methods as in our Healthy Start diversity supplement. Data will be entered into the NDSR program, which will be used to average data across both days and then calculate HEI-2015 score using same methods as for childcare.
Dietary Observation in Child Care	Baseline and 9 months	HEI Score - Diet Quality in Childcare Dietary Observation for Childcare (DOCC) is a validated visual observation technique that minimizes observer intrusion, so children don't know intake is being observed. Observers visually estimate and record amount /type of foods/beverages served to children in meals/snacks. Foods not easily discerned will be clarified with FCCP (e.g. food prep, brand names). Amount of food wasted (e.g. dropped, spilled, traded) and remaining will be recorded and amount of food consumed will be estimated as amount served - amount remaining. -Both days of observation data will be entered into NDSR, and averaged to estimate daily nutrient and food data. -Nutrient content, HEI-2015 total and component scores will be derived

Secondary Outcome Measures

Name	Time	Method
Veggie Meter	Baseline and 9 months	Carotenoid Score Provides an objective measure of F\&V intake using reflection spectroscopy to detect non-invasively, the level of carotenoids in the child's skin.
Environment and Policy Assessment and Observation Tool	Baseline and 9 months	EPAO Score Measures childcare nutrition environments and practices over a full-day.
Child Weight	Baseline and 9 months	Weight (kg) Investigators will use standard techniques for measuring child weight in kilograms
Child Height	Baseline and 9 months	Height (cm) Investigators will use standard techniques for measuring child height in cm.
Feeding Practices	Baseline and 9 months	CFPQ Score Parents will be surveyed about their feeding practices of their own children at home. 32 questions from the Comprehensive Feeding Practices Questionnaire (CFPQ) will be used.
Beverage Intake Questionnaire (BEVQ-PS)	Baseline and 9 months	BEVQ-PS is a valid instrument used to assess SSB, water, and whole-milk intake.
Rapid Prime Diet Quality Score (rPDQS)	Baseline and 9 months	rPDQS Score The rPDQS is a valid, brief diet quality screener that identifies clinically relevant patterns of food intake.