Clinical trial NCT06099288: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome, Protection Against
Diet, Healthy
Keywords: Motivational Interview
Home-Based
Intervention
Latinx
Families
Nutrition
Cultural Tailoring
Social Cognitive Theory
Self-Determination Theory
Self-Perception Theory
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-25
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After baseline measures are complete, parent-child dyads will be randomly assigned to either the Intervention (I) or Comparison group (C) using random generator software. Because parents will need to complete a second recall over the phone after completing in-person measurements, randomization will happen over the phone. The project manager will let parents know by phone what group they are in and conduct an orientation about upcoming activities for each group.
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Child Diet Quality
timeFrame: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up
measure: Child's Dermal Carotenoids
timeFrame: Baseline, 6-Month Follow-up
Secondary outcomes:
measure: Food Parenting Practices
timeFrame: Baseline, 6-Month Follow-up
measure: Availability of Healthy Foods in the Home
timeFrame: Baseline, 6-Month Follow-up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Alison Tovar, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: