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Clinical Trials/NCT06398509
NCT06398509
Recruiting
Not Applicable

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

University of California, San Francisco4 sites in 1 country576 target enrollmentMay 13, 2024

Overview

Phase
Not Applicable
Intervention
Futuros Fuertes 2.0
Conditions
Obesity, Childhood
Sponsor
University of California, San Francisco
Enrollment
576
Locations
4
Primary Endpoint
BMI Z-score
Status
Recruiting
Last Updated
16 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 13, 2024
End Date
June 1, 2029
Last Updated
16 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Futuros Fuertes 2.0

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.

Intervention: Control

Outcomes

Primary Outcomes

BMI Z-score

Time Frame: 24-months

BMI Z-score based on WHO growth curves

Secondary Outcomes

  • Breastfeeding(First year of life)
  • Screen time(24-months)
  • Sleep duration(24-months)
  • Fruit and vegetable intake(24-months)
  • Sugar sweetened beverage and 100% fruit juice intake(24-months)
  • Change in BMI Z-score(6-months to 24-months)

Study Sites (4)

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