Strong Families Start at Home/Familias Fuertes Comienzan en Casa

Diet, Healthy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Diet, Healthy
• Metabolic Syndrome
• Metabolic Syndrome, Protection Against

• NCT number: NCT06099288
• Study type: Interventional
• Source: Brown University
• Contact: Alison Tovar, PhD MPH
• Phone: 401-863-7327
• Email: alison_tovar@brown.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: November 1, 2027