Recruiting

Childhood Obesity

Sponsor:

UCLA

Code:

NCT06398509

Conditions

Obesity, Childhood

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Control

Futuros Fuertes 2.0

Study Details

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.

Conditions

Obesity, Childhood

Study ID

NCT06398509

Start date

May 13, 2024

Status verified date

Apr, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

576 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amy Beck, MD, MPH

415-476-3368amy.beck@ucsf.edu

Locations

Children's Health Center San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Valley Health Center Sunnyvale

Recruiting

Sunnyvale, California, United States, 94086

Contacts

Amy Beck

415-476-3368amy.beck@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-16.