Strong Families Start at Home/Familias Fuertes Comienzan en Casa

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT06099288
Status
Recruiting
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Conditions

  • Diet, Healthy
  • Metabolic Syndrome, Protection Against

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Home-Based Video and Motivational Interviewing Intervention — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
May 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
257 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Child Diet Quality [ Time Frame: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02912
Alison Tovar
[email protected]
617-599-0751
[email protected]
Alison Tovar (PRINCIPAL_INVESTIGATOR)

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Brown University· Providence, RI

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