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Clinical Trials/NCT06099288
NCT06099288
Recruiting
N/A

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

Brown University1 site in 1 country257 target enrollmentJanuary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Metabolic Syndrome, Protection Against
Sponsor
Brown University
Enrollment
257
Locations
1
Primary Endpoint
Child Diet Quality
Status
Recruiting
Last Updated
11 months ago

Overview

Brief 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.

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

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
November 1, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Child Diet Quality

Time Frame: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up

Caloric and macronutrient intake will be averaged over two dietary recalls. Caloric and macronutrient intake will be averaged over the two recalls. Healthy Eating Index (HEI)-2015 components (total fruit, whole fruit, total vegetable, dark green and orange vegetables and legumes, total grain, whole grain, milk, meat and beans, saturated fat, sodium, added sugars, and solid fats) are assessed per 1000 kcal to provide a density-based score except for saturated fats and added sugars with are % of energy. Component scores are then summed to provide a total HEI score.

Child's Dermal Carotenoids

Time Frame: Baseline, 6-Month Follow-up

The Veggie Meter device will provide an objective, non-invasive and quick measure reflecting fruit and vegetable intake. This device uses reflection spectroscopy to detect the level of carotenoids in human skin. Three measures (10 seconds each spaced by 30-seconds) will be taken and averaged. Scores range from 0 to 800 with higher scores indicating greater fruit and vegetable intake.

Secondary Outcomes

  • Food Parenting Practices(Baseline, 6-Month Follow-up)
  • Availability of Healthy Foods in the Home(Baseline, 6-Month Follow-up)

Study Sites (1)

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