A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children
Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children
2 other identifiers
interventional
576
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedStudy Start
First participant enrolled
May 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
April 16, 2026
April 1, 2026
5.1 years
May 1, 2024
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
BMI Z-score
BMI Z-score based on WHO growth curves
24-months
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Other Outcomes (3)
Screen time
6-months, 12-months and 18-months
Sleep duration
6-months, 12-months, 18-months
Sugar-sweetened beverages and 100% fruit juice
6-months, 12-months, 18-months
Study Arms (2)
Intervention
EXPERIMENTALThe 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.
Control
ACTIVE COMPARATORThe 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Infant has a serious medical condition that affects feeding or growth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Health Center San Francisco General Hospital
San Francisco, California, 94110, United States
Valley Health Center Sunnyvale
Sunnyvale, California, 94086, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Beck, MD, MPH
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2024
First Posted
May 3, 2024
Study Start
May 13, 2024
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
After completion of the study, final research data will be available for use by other investigators, federal agencies, or other appropriate organizations or personnel upon request. Research data will be shared in a de-identified data set to protect subject privacy.