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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06398509
Status
Recruiting
Apply to this trial

Conditions

  • Obesity, Childhood

Eligibility Criteria

Sex
ALL
Age
7 Days - 2 Months
Healthy Volunteers
Not accepted

Interventions

  • Control — BEHAVIORAL
    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.
  • Futuros Fuertes 2.0 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 13, 2024
Status verified
Apr 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
576 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

BMI Z-score [ Time Frame: 24-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Health Center San Francisco General HospitalSan FranciscoCalifornia94110
Amy Beck, MD MPH
Valley Health Center SunnyvaleSunnyvaleCalifornia94086
Amy Beck
[email protected]
415-476-3368

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By research site
Children's Health Center San Francisco General Hospital· San Francisco, CAValley Health Center Sunnyvale· Sunnyvale, CA

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