Healthy Start: Family Childcare Providers and Parents

Brown University

Status: Not yet enrolling

Conditions: Nutrition, Healthy; Child Obesity

Treatments: Behavioral: Healthy Eating: Provider and Parent Components; Behavioral: Healthy Start: Reading Readiness Childcare Proiver and Parent Materials

Study type: Interventional

Funder types: Other

Identifiers

NCT06978270

DK131940-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Providers:

Inclusion Criteria:

• English and/or Spanish-speaking and reading
• State licensed family childcare providers (FCCP)
• FCCP that care for 18-54 month-old children,
• Plan for FCCH to be in operation for the next year
• Willing 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

Exclusion Criteria:

• Participation in the prior Healthy Start Project

Parents:

Inclusion Criteria:

• English and/or Spanish-speaking and reading
• Legal guardian of child(ren) who receive care in a participating FCCH
• Child(ren) must be 18-54 months-old
• Care must be for at least 15 hrs./wk
• Plan to continue childcare with their current FCCP for the next 9 months
• Be the caregiver mainly responsible for the child's eating at home
• Willing to be randomized (with the FCCP) 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
• Care must be for at least 15 hours per week
• Agree to be measured (All other evaluation is observation that does not require assent).

Exclusion Criteria:

• Not meeting above criteria.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Healthy Start: Healthy Eating in Childcare and Home Settings

Experimental group

Description:

1) Adapted version of Healthy Start nutrition intervention (peer coach using brief MI online, tailored materials, coach-led online support groups for FCCP and children's tableware and food toys for the FCCH); 2) Brief training from coach on using and scheduling healthy eating messages within the Classtag App; 3) Posters for the FCCH; 4) Tailored health eating packets (newsletters, videos and tableware/food toys) for parents.

Treatment:

Behavioral: Healthy Eating: Provider and Parent Components

Healthy Start: Reading Readiness in Childcare and at Home

Active Comparator group

Description:

An attention-matched intervention re. reading readiness and literacy promotion based on the dialogic reading technique to be delivered with a similar dose and intensity including reading readiness-focused Tailored feedback reports, monthly support coach calls, Classtag App, and tailored packets (with FCCP and parent materials) distributed monthly and online peer support groups. The FCCP will select which of the reading readiness-related and early literacy skills topics they want to work on monthly. FCCP and parents in this group will receive a set of books.

Treatment:

Behavioral: Healthy Start: Reading Readiness Childcare Proiver and Parent Materials