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

NCT ID: NCT06398509

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-13

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Futuros Fuertes 2.0

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type 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.

Interventions

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Control

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.

Intervention Type BEHAVIORAL

Futuros 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Days

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Beck, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Children's Health Center San Francisco General Hospital

San Francisco, California, United States

Site Status RECRUITING

Valley Health Center Sunnyvale

Sunnyvale, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy Beck, MD, MPH

Role: CONTACT

415-476-3368

Facility Contacts

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Amy Beck, MD MPH

Role: primary

Amy Beck

Role: primary

415-476-3368

Other Identifiers

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1R01HD109158

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-38707

Identifier Type: -

Identifier Source: org_study_id

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