Strong Families Start at Home/Familias Fuertes Comienzan en Casa

Brown University

Status: Enrolling

Conditions: Metabolic Syndrome, Protection Against; Diet, Healthy

Treatments: Behavioral: Read Educate and Develop Youth (READY) Comparison; Behavioral: Home-Based Video and Motivational Interviewing Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06099288

2022003389

R01HD108832 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 257 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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257 participants in 2 patient groups

Home-Based Video and Motivational Interviewing Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Home-Based Video and Motivational Interviewing Intervention

Read Educate and Develop Youth (READY) Comparison

Active Comparator group

Description:

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.

Treatment:

Behavioral: Read Educate and Develop Youth (READY) Comparison