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NCT Number: NCT06398509

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

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.

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Key information

Age range

7 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Health Center San Francisco General Hospital, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Behavioral

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.

Futuros Fuertes 2.0

Behavioral

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.

Primary outcomes

  1. BMI Z-score

    Time frame: 24-months

    BMI Z-score based on WHO growth curves

Secondary outcomes

  1. Breastfeeding

    Time frame: First year of life

    Duration of breastfeeding in first year of life

  2. Screen time

    Time frame: 24-months

    Daily screen time

  3. Sleep duration

    Time frame: 24-months

    Daily sleep duration

  4. Fruit and vegetable intake

    Time frame: 24-months

    Daily fruit and vegetable intake

  5. Sugar sweetened beverage and 100% fruit juice intake

    Time frame: 24-months

    Weekly ounces of sugar-sweetened beverages and 100% fruit juice

  6. Change in BMI Z-score

    Time frame: 6-months to 24-months

    Trajectory of BMI Z-score (WHO growth curve)

Other outcomes

  1. Screen time

    Time frame: 6-months, 12-months and 18-months

    Daily screen time

  2. Sleep duration

    Time frame: 6-months, 12-months, 18-months

    Daily sleep duration

  3. Sugar-sweetened beverages and 100% fruit juice

    Time frame: 6-months, 12-months, 18-months

    Weekly ounces of sugar-sweetened beverages and 100% fruit juice

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Beck, MD, MPH

CONTACT

[email protected]

415-476-3368

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 3, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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