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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Obesity, Childhood

Treatments: Behavioral: Control; Behavioral: Futuros Fuertes 2.0

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06398509

23-38707

1R01HD109158 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 576 estimated patients

Sex: All

Ages: 7 days to 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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576 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Futuros Fuertes 2.0

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control