Strong Families Start at Home/Familias Fuertes Comienzan en Casa

NCT06099288 | Recruiting

• 2 other identifiers: 2022003389R01HD108832
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Food Parenting Practices

  Baseline, 6-Month Follow-up

• Availability of Healthy Foods in the Home

  Baseline, 6-Month Follow-up

Study Arms (2)

Home-Based Video and Motivational Interviewing Intervention

EXPERIMENTAL

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.

Behavioral: Home-Based Video and Motivational Interviewing Intervention

Read Educate and Develop Youth (READY) Comparison

ACTIVE COMPARATOR

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.

Behavioral: Read Educate and Develop Youth (READY) Comparison

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.

Home-Based Video and Motivational Interviewing Intervention

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.

Read Educate and Develop Youth (READY) Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

Related Publications (1)

• Tovar A, Bouchard KL, Moore AM, Perry M, Lurssen I, Arriola Carnicelli L, Sanchez Contreras A, Risica P, von Ash T, Savage JS, Dunsiger S, Gans K. Strong Families Start at Home/Familias Fuertes Comienzan en Casa-Improving Child Diet Quality and Parental Feeding Practices: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73923. doi: 10.2196/73923.

  PMID: 40929716 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alison Tovar, PhD MPH

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Tovar, PhD MPH

CONTACT

401-863-7327; alison_tovar@brown.edu

Kelly Bouchard, MPH

CONTACT

kelly_bouchard@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Intervention staff (Project coordinator \& Community Health Workers) will know what group each participant has been allocated to. Evaluation teams will be masked. Additionally, participants will know if they have been assigned to the group focused on "child feeding" or the group focused on "child reading readiness", but will not be told that one is the intervention group and one is the comparison group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 25, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)