Strong Families Start at Home/Familias Fuertes Comienzan en Casa

Official title

Strong Families Start at Home/Familias Fuertes Comienzan en Casa: A Novel Video and Motivational Interviewing Intervention to Improve Diet Quality of Low-income, Ethnically Diverse Children

Overview

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.

Detailed 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

Interventions

• Behavioral Home-Based Video and Motivational Interviewing Intervention
  The intervention consists of three home-based visits, followed by phone calls during the last three months of the intervention. For each visit and phone call, participants will receive tailored print materials, and during the 6 months of the interventions, they will receive text messages 2x/week. The intervention will be delivered in English or Spanish by a bilingual Community Health Worker (CHW). The CHW will be hired to serve as MI counselors for the parents in the study, and will be in charge
• Behavioral Read Educate and Develop Youth (READY) Comparison
  The comparison group will receive an attention contact control intervention about school readiness promotion adapted from R.E.A.D.Y. (Read Educate and Develop Youth) designed by the Michigan Department of Education. The intervention consists of three home-based visits, followed by phone calls during the last three months of the intervention. For each visit and phone call, participants will receive tailored print materials, and during the 6 months of the interventions, they will receive text mess

Primary outcome measures

• Child Diet Quality [Time frame: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up]
• Child's Dermal Carotenoids [Time frame: Baseline, 6-Month Follow-up]

Secondary outcome measures (2)

• Food Parenting Practices [Time frame: Baseline, 6-Month Follow-up]
• Availability of Healthy Foods in the Home [Time frame: Baseline, 6-Month Follow-up]

Eligibility criteria

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 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 how they eat

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Brown University — Providence

Publications

• Tovar A, Bouchard KL, Moore AM, Perry M, Lurssen I, Arriola Carnicelli L, Sanchez Contreras A, Risica P, von Ash T, Savage JS, Dunsiger S, Gans K. Strong Families Start at Home/Familias Fuertes Comienzan en Casa-Improving Child Diet Quality and Parental Feeding Practices: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73923. doi: 10.2196/73923. PMID 40929716

Identifiers

NCT: NCT06099288 · 2022003389 · R01HD108832

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗