Futuros Fuertes 2.0

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398509
• Other study ID #: 23-38707
• Secondary ID: 1R01HD109158
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: September 1, 2029

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Amy Beck, MD, MPH
• Phone: 415-476-3368
• Email: amy.beck[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 576
• Est. completion date: September 1, 2029
• Est. primary completion date: September 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Days to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Health Center San Francisco General Hospital	San Francisco	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Screen time	Daily screen time	6-months, 12-months and 18-months
Other	Sleep duration	Daily sleep duration	6-months, 12-months, 18-months
Other	Sugar-sweetened beverages and 100% fruit juice	Daily ounces of sugar-sweetened beverages and 100% fruit juice	6-months, 12-months, 18-months
Primary	BMI Z-score	BMI Z-score based on WHO growth curves	24-months
Secondary	Breastfeeding	Duration of breastfeeding in first year of life	First year of life
Secondary	Screen time	Daily screen time	24-months
Secondary	Sleep duration	Daily sleep duration	24-months
Secondary	Fruit and vegetable intake	Daily fruit and vegetable intake	24-months
Secondary	Sugar sweetened beverage and 100% fruit juice intake	Daily ounces of sugar-sweetened beverages and 100% fruit juice	24-months
Secondary	Change in BMI Z-score	Trajectory of BMI Z-score (WHO growth curve)	6-months to 24-months