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

University of California San Francisco (UCSF) logo

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

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

Trial contacts and locations

2

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Central trial contact

Amy Beck, MD, MPH

Data sourced from clinicaltrials.gov

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