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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06398509
Enrollment
576
Registered
2024-05-03
Start date
2024-05-13
Completion date
2029-06-01
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

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.

Interventions

BEHAVIORALControl

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.

BEHAVIORALFuturos 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Days to 2 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BMI Z-score24-monthsBMI Z-score based on WHO growth curves

Secondary

MeasureTime frameDescription
BreastfeedingFirst year of lifeDuration of breastfeeding in first year of life
Screen time24-monthsDaily screen time
Sleep duration24-monthsDaily sleep duration
Fruit and vegetable intake24-monthsDaily fruit and vegetable intake
Sugar sweetened beverage and 100% fruit juice intake24-monthsWeekly ounces of sugar-sweetened beverages and 100% fruit juice
Change in BMI Z-score6-months to 24-monthsTrajectory of BMI Z-score (WHO growth curve)

Countries

United States

Contacts

CONTACTAmy Beck, MD, MPH
amy.beck@ucsf.edu415-476-3368
PRINCIPAL_INVESTIGATORAmy Beck, MD, MPH

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026