A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children

Not Applicable

Recruiting

• Conditions: Obesity, Childhood
• Interventions: Behavioral: Futuros Fuertes 2.0; Behavioral: Control

• Registration Number: NCT06398509
• Lead Sponsor: University of California, San Francisco

Brief Summary

The goal of this study is to evaluate the impact of a primary care based intervention to promote optimal feeding, screen time and sleep practices among low-income Latino infants and toddlers. Infants and caregivers will receive brief health education and coaching sessions from health educators at primary care visits in the first two years of life as well as two text messages per week with health information and tips. Half of the participants will receive the Futuros Fuertes 2.0 intervention that includes health coaching and education on infant feeding, screen time and sleep (intervention group). The other half will receive health coaching and education on safety, home management of childhood illnesses, and promotion of language development (control group). We will look at the impact of the Futuros Fuertes 2.0 intervention on child BMI and various health behaviors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-03
• Study Start: 2024-05-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

• Parent/caregiver self identifies as Latino
• Parent/caregiver speaks Spanish or English
• Parent/caregiver intends to receive primary care for infant at participating clinic
• Infant gestational age of 37 weeks or greater
• Infant birthweight of 2600 grams or greater
• For multiples (twins, triplets), one sibling will be chosen at random to participate

Exclusion Criteria

-Infant has a serious medical condition that affects feeding or growth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Futuros Fuertes 2.0	The Futuros Fuertes 2.0 intervention includes brief health education and coaching at well child visits in the first two years of life that addresses optimal feeding, screen time and sleep practices. In addition, caregivers receive 2 text messages per week. Caregivers also receive environmental prompts to help support healthy behaviors at home.
Control	Control	The control intervention includes brief health education and coaching at well child visits in the first two years of life that addresses home safety, management of common childhood illnesses, and promotion of language development. In addition, caregivers receive 2 text messages per week. Caregivers also receive environmental prompts to help support healthy behaviors at home.

Primary Outcome Measures

Name	Time	Method
BMI Z-score	24-months	BMI Z-score based on WHO growth curves

Secondary Outcome Measures

Name	Time	Method
Breastfeeding	First year of life	Duration of breastfeeding in first year of life
Screen time	24-months	Daily screen time
Sleep duration	24-months	Daily sleep duration
Fruit and vegetable intake	24-months	Daily fruit and vegetable intake
Sugar sweetened beverage and 100% fruit juice intake	24-months	Weekly ounces of sugar-sweetened beverages and 100% fruit juice
Change in BMI Z-score	6-months to 24-months	Trajectory of BMI Z-score (WHO growth curve)

Trial Locations

Locations (2)

Valley Health Center Sunnyvale; 🇺🇸 Sunnyvale, California, United States

Children's Health Center San Francisco General Hospital; 🇺🇸 San Francisco, California, United States