A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control, Futuros Fuertes 2.0.
- Who it may be relevant to
- Registry conditions: Obesity, Childhood. Basic parameters: 7 Days — 2 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children
Overview
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
- Behavioral 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. - 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.
Primary outcome measures
- BMI Z-score [Time frame: 24-months]
Secondary outcome measures (6)
- Breastfeeding [Time frame: First year of life]
- Screen time [Time frame: 24-months]
- Sleep duration [Time frame: 24-months]
- Fruit and vegetable intake [Time frame: 24-months]
- Sugar sweetened beverage and 100% fruit juice intake [Time frame: 24-months]
- Change in BMI Z-score [Time frame: 6-months to 24-months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Children's Health Center San Francisco General Hospital — San Francisco
- Valley Health Center Sunnyvale — Sunnyvale
Identifiers
NCT: NCT06398509 · 23-38707 · 1R01HD109158