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

Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Futuros Fuertes 2.0; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 576
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Beck, MD, MPH; Phone Number: 415-476-3368; Email: amy.beck@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Children's Health Center San Francisco General Hospital
      • Contact: Amy Beck, MD MPH
    • Sunnyvale, California, United States, 94086
      • Recruiting
      • Valley Health Center Sunnyvale
      • Contact: Amy Beck; Phone Number: 415-476-3368; Email: amy.beck@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Futuros Fuertes 2.0; The Futuros Fuertes 2.0 intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The Futuros Fuertes 2.0 intervention focuses on optimal infant feeding, screen time, and sleep practices.
Active Comparator: 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.	Behavioral: Control; The control intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The control intervention focuses on home safety, home management of common childhood illnesses, and promotion of language development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI Z-score	BMI Z-score based on WHO growth curves	24-months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen time	Daily screen time	6-months, 12-months and 18-months
Sleep duration	Daily sleep duration	6-months, 12-months, 18-months
Sugar-sweetened beverages and 100% fruit juice	Weekly ounces of sugar-sweetened beverages and 100% fruit juice	6-months, 12-months, 18-months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Amy Beck, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: 23-38707; 1R01HD109158 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion of the study, final research data will be available for use by other investigators, federal agencies, or other appropriate organizations or personnel upon request. Research data will be shared in a de-identified data set to protect subject privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No