Family Intervention to Prevent Childhood Obesity

NCT05606731 | Recruiting DMC

• 1 other identifier: 1R01AMD016135-01A1
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

Consumption of sweetened beverages, media-viewing, and physical activity patterns are often established during early childhood, and family-based obesity interventions show effectiveness in shaping healthy behaviors and weight outcomes for young children, including Latino children. Missing from these interventions, however, are methods to increase accessibility and dissemination to multiple family caregivers. The proposed work will use a randomized study design to evaluate the impact a family-based early childhood obesity intervention for Latino families that incorporates evidence-based strategies of in-person childhood obesity interventions, mobile phones, and leverages important determinants of Latino health (e.g. familism, language) in order to decrease ethnic disparities in childhood obesity and cardiovascular risk.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (4)

• Child BMI

  BMI in kg/m\^2 based on measured weight in kg and height in meters.

  baseline

• Child BMI

  BMI in kg/m\^2 based on measured weight in kg and height in meters

  change in baseline and 1-month post baseline. A lower BMI from baseline is a better outcome.

• Child BMI

  BMI in kg/m\^2 based on measured weight in kg and height in meters

  change in baseline and 6-month post baseline. A lower BMI from baseline is a better outcome.

• Child BMI

  BMI in kg/m\^2 based on measured weight in kg and height in meters. A lower BMI from baseline is a better outcome.

  change in baseline and 12-month post baseline

Secondary Outcomes (9)

• Dietary Intake

  baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline

• Media Viewing Practices

  baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline

• Child Physical Activity Patterns

  baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline

• Latino toddler eating and dietary practices

  baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline

• Family Cohesion

  baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

The study's intervention is a parenting/caregiver training program that includes 1-month of weekly in-person sessions plus multi-media interactive text messaging. The weekly 1-hour-in-person sessions will be coupled with four interactive messages per week for a period of 4 weeks total, followed by "booster" text messages after completing the 4-week program.

Behavioral: Family-Based Childhood Obesity Intervention

Usual Care

NO INTERVENTION

"Usual care" for caregivers of 2- to-5-year-olds will include the Women Infant and Children services : (1) monthly vouchers for nutritious food; (2) individual nutrition counseling at least twice per year; (3) nutrition education two times per year (1:1 counseling or online health education modules); and (4) referrals to family services.

Interventions

Family-Based Childhood Obesity Intervention BEHAVIORAL

The study will focus on the effectiveness of a community- and family-based intervention that will involve multiple family caregivers. The intervention will include in-person and mobile phone components focusing on Latino caregivers of young children, to support evidence-based and age appropriate dietary, media-viewing, and physical activity practices among 2- to 5-year old children.

Intervention Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult caregivers of a young child who:
• self-identify as an individual of Latino descent
• have a 2- to 5-year-old child/grandchild who is overweight or obese, defined as having a BMI\>85% for age and sex
• lives with or cares for the child at least 20 hours per week (the relationship does not have to be biological
• speaks Spanish or English
• ability and willingness to participate in the intervention (determined with a Subject Comprehension and Participation Assessment Tool)
• agrees to complete baseline, 1-, 6-, 12-month post-intervention data collection protocols

You may not qualify if:

• Caregivers of a child with:
• medical conditions related to overweight status such as Prader-Willi Syndrome
• taking weight loss medication
• participating in a weight loss program.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, Merced: collaborator

Study Sites (1)

Head Start

Los Angeles, California, 90670, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alma D Guerrero, MD, MPH

CONTACT

(310) 267-2789; aguerrero@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants who will collect surveys and measurement data will be blinded to participation condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: A prospective randomized 2-arm clinical trial

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 7, 2022
• Study Start: November 6, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Baseline data within two years after study recruitment is complete or within six months of the publication date of the baseline data, whichever comes first. All study data analyzed for publication of the primary study outcome(s) will be provided to the NIH Repository so that it can be shared within six months of the publication date for the primary outcome publication or within two years of the date that the database is locked for analysis, whichever occurs first.

Locations

US (1)