Recruiting

Parental Nutrition

Sponsor:

Brown University

Code:

NCT06099288

Conditions

Metabolic Syndrome, Protection Against

Diet, Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Home-Based Video and Motivational Interviewing Intervention

Read Educate and Develop Youth (READY) Comparison

Study Details

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.

Conditions

Metabolic Syndrome, Protection Against

Diet, Healthy

Study ID

NCT06099288

Start date

Jan 1, 2024

Status verified date

Aug, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

257 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Home-Based Video and Motivational Interviewing Intervention

The intervention will be delivered in English or Spanish by a trained CHW and consists of three home-based visits with tailored print materials, text-messages delivered 2x/week, followed by monthly tailored print materials and phone calls during the last three months of the intervention. For in-home visits, the CHW will deliver a Motivational Interviewing session based on scripts developed in the R34. For phone calls, parents will receive a 30-minute Motivational Interviewing phone call to check in on goals and barriers and reinforce earlier concepts. For text messages, parents will be sent two times/week messages related to objectives targeted during that month's visit, such as parents setting good examples and giving children autonomy in eating. For print materials, parents will receive printed materials, highlighting nutrition and parental feeding guidance.

active comparator: Read Educate and Develop Youth (READY) Comparison

As done in the R34, 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 (Refs). Families in the comparison arm will receive the same intervention components as the intervention arm, but these will be focused on child reading rather than nutrition. Parents will send a video of themselves reading with a child, receive 3 home visits and 48 text-messages as well as newsletters for each visit. Instead of receiving cooking materials during the second home visit, they will receive books to read with their children.

Interventions

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 of delivering the MI in-home or telephone sessions. CHWs will be trained for 3 months, in Motivational Interviewing, study protocols, the use of video recordings, meal preparation, and cooking, and will undergo a MI certification process. During the sessions with the participants, the CHW will deliver semi-scripted MI sessions based on the scripts developed in the pilot study.

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 messages 2x/week. The intervention will be delivered in English or Spanish by a bilingual Community Health Worker (CHW). Families will receive the same intervention components as the intervention, but about reading instead of nutrition.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kelly Bouchard, MPH

kelly_bouchard@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Principal Investigator:

Alison Tovar

More Information

Sponsor

Brown University

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Motivational Interview
  • Home-Based
  • Intervention
  • Latinx
  • Families
  • Nutrition
  • Cultural Tailoring
  • Social Cognitive Theory
  • Self-Determination Theory
  • Self-Perception Theory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2026-08-06.