Strong Families Start at Home/Familias Fuertes Comienzan en Casa

Last updated: May 6, 2025
Sponsor: Brown University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Metabolic Syndrome

Metabolic Disorders

Treatment

Read Educate and Develop Youth (READY) Comparison

Home-Based Video and Motivational Interviewing Intervention

Clinical Study ID

NCT06099288
2022003389
R01HD108832
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to test the ability of a home-based parental nutrition intervention to improve diet quality in preschool aged children within low-income, Latinx/Hispanic families. The main questions it aims to answer are:

  • Does this enhanced intervention change children's diet quality?

  • Does this enhanced intervention change parental feeding practices?

  • Does this enhanced intervention change the availability of healthy foods in the home?

Participants will:

  • Work with a support coach

  • Have a home visit with a support coach once a month, for three months

  • Have a phone call with a support coach once a month, for three months

  • Receive written materials and text messages over the six months

Researchers will compare a control group receiving different written materials and messages to see if the enhanced intervention changes diet quality in children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old

  • Self-identity as Latinx/Hispanic

  • Speak English or Spanish

  • Be the primary caregiver of a child between 2- 5 years of age

  • Live with the child most of the time

  • Eat a minimum of three evening meals per week with the child

  • Not have participated in the R34 study

  • Have a smart phone

  • Be willing to have a meal video recorded in the home

Exclusion

Exclusion Criteria:

  • A doctor or WIC provider has told them that their child was underweight in the past 6 months

  • The child has a diagnosed feeding disorder or dietary restriction that impacts howthey eat

Study Design

Total Participants: 257
Treatment Group(s): 2
Primary Treatment: Read Educate and Develop Youth (READY) Comparison
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
November 01, 2027

Study Description

Investigators will build on the recently completed R34 (R34HL140229) that developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a novel home-based intervention to improve the diet quality and home food environment of low-income, ethnically diverse preschool children (87% Latinx). Despite the study occurring during COVID-19, the intervention delivery was feasible and acceptable to participants and achieved encouraging improvements in children's diet quality and positive food parenting practices. For the proposed research the investigators will build upon lessons learned in the pilot to evaluate the efficacy of the novel Strong Families intervention to improve food parenting practices, home food environment, parent, and children's diet quality in a fully powered randomized controlled trial (RCT) with 257 families of a 2-5-year-old child. The intervention will include:

  • Home visits by a community health worker (CHW) trained in brief motivational interviewing; screening for social-determinants of health and connecting families to federal/state/local resources; in-home cooking demonstrations to prepare a meal involving their child; feedback about a family meal-time video

  • Text-messages

  • Tailored materials/messages

  • CHW phone calls

These strategies are expected to connect families to community systems, increase parental knowledge, self-efficacy, and motivation for serving easy, inexpensive healthy foods leading to increased child exposure to more healthy and varied foods, improvements in parental feeding practices and ultimately, improvements in child diet quality. The RCT will include baseline, 6 & 12-month measurements to test the following aims:

  • Aim 1: Improve the dietary intakes of 2-5-year-old children

  • Aim 2: Improve food parenting practices

  • Aim 3. Improve the availability of healthy foods in the home

Connect with a study center

  • Brown University

    Providence, Rhode Island 02912
    United States

    Active - Recruiting

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