Recruiting

Family Intervention

Sponsor:

UCLA

Code:

NCT05606731

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Family-Based Childhood Obesity Intervention

Study Details

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

Study ID

NCT05606731

Start date

Nov 6, 2023

Status verified date

Mar, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Design

Enrollment

182 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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.

no intervention: Usual Care

"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

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.

Primary outcome measure

  • Child BMI [ Time Frame: baseline ]
  • Child BMI [ Time Frame: change in baseline and 1-month post baseline. A lower BMI from baseline is a better outcome. ]
  • Child BMI [ Time Frame: change in baseline and 6-month post baseline. A lower BMI from baseline is a better outcome. ]
  • Child BMI [ Time Frame: change in baseline and 12-month post baseline ]

Central Contacts and Locations

Central contacts

Alma D Guerrero, MD, MPH

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

Locations

Head Start

Recruiting

Los Angeles, California, United States, 90670

Contacts

Debra Hall

562-940-1657Hall_Debra@lacoe.edu

Cecilia Maldonado

Maldonado_Cecilia@lacoe.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 10, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-03-10.