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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-2
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

576 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

BMI Z-score

BMI Z-score based on WHO growth curves

Time frame
24-months

Secondary outcomes

1

Breastfeeding

Duration of breastfeeding in first year of life

Time frame
First year of life
2

Screen time

Daily screen time

Time frame
24-months
3

Sleep duration

Daily sleep duration

Time frame
24-months
4

Fruit and vegetable intake

Daily fruit and vegetable intake

Time frame
24-months

Other outcomes

1

Screen time

Daily screen time

Time frame
6-months, 12-months and 18-months
2

Sleep duration

Daily sleep duration

Time frame
6-months, 12-months, 18-months
3

Sugar-sweetened beverages and 100% fruit juice

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

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

Collaborator