Strong Families Start at Home/Familias Fuertes Comienzan en Casa

Diet, Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099288
• Other study ID #: 2022003389
• Secondary ID: R01HD108832
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: November 1, 2027

Study information

• Verified date: February 2024
• Source: Brown University
• Contact: Alison Tovar, PhD MPH
• Phone: 401-863-7327
• Email: alison_tovar[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 257
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Metabolic Syndrome
• Metabolic Syndrome, Protection Against

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Diet Quality	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.	2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up
Primary	Child's Dermal Carotenoids	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.	Baseline, 6-Month Follow-up
Secondary	Food Parenting Practices	Food parenting practices will be measured by the Food Parenting Inventory. Investigators will measure pre-post changes to 8 subscales: 1) child involvement in food preparation; 2) responsiveness to child's fullness cues; 3) encourage exploration of new foods; 4) repeated presentation of new foods; 5) regular timing of meals and snacks; 6) encourage try new foods; 7) inconsistent mealtimes; 8) food as a reward; and the Healthy Eating Guidance subscale of the Comprehensive Feeding Practices Questionnaire. All of the items are rated on a 5-point Likert scale ranging from never-always and disagree-agree. Higher subscale scores indicate greater use of that practice.	Baseline, 6-Month Follow-up
Secondary	Availability of Healthy Foods in the Home	The Home Food Inventory (HFI) will be used to assess a range of available foods in the home environment. Research staff will inventory the foods in the kitchen. The HFI includes 13 food categories (e.g., cheese, milk/dairy, F&V), whether F&V were fresh, canned/jarred, frozen, or dried, and two categories on food accessibility. HFI items are listed in a checklist format with yes/no options.	Baseline, 6-Month Follow-up