Personalized Interventions for Childhood Obesity (COACH Trial)

Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority communities.

Eligibility Criteria

This trial is for families with a parent/guardian at risk for obesity but not severely obese, and a child aged 4-7 years. They must be Hispanic/Latino, speak English or Spanish, have mobile phone access, and commit to a two-year study. Participants should live in specified Nashville zip codes if attending in person or any location for videoconferencing. Families must qualify as underserved by participating in certain assistance programs.

Inclusion Criteria

My child's BMI is in the 5th percentile or higher for their age and gender.

I have regular access to a mobile phone.

My child is between 4 and 6 years old.

My guardian's BMI indicates a risk for obesity but not severe obesity.

Exclusion Criteria

My child is below the 5th percentile in growth according to CDC charts.

My BMI is either below 25 or above 40.

I am not within the specified age range for children.

My parent or guardian has poor eyesight.

My parent or legal guardian is under 18 years old.

I do not have a working phone.

My child does not speak English or Spanish.

Treatment Details

The COACH program and School Readiness Intervention are being tested to prevent childhood obesity among low-income minority families. The interventions are personalized to help these families maintain healthy behaviors despite changing barriers.

2Treatment groups

Experimental Treatment

Active Control

Group I: COACH InterventionExperimental Treatment1 Intervention

COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 4-6 year old children; 2) family-based content that both targets parent weight loss and leverages a shared parent-child experience to improve family health behaviors; 3) community-level intervention to improve access and quality of family-based programming at local Parks and Rec centers.

Group II: Educational ControlActive Control1 Intervention

The control arm will consist of a school readiness intervention developed by education and literacy experts on our team and implemented at local libraries. It will include 1) child lessons from Puente de Cuentos, a systematic, language-based curriculum focused on dual language storytelling (narrative language), and 2) parent sessions designed to improve parents' knowledge and skills related to improving children's language production and storytelling skills, to ultimately support school readiness.

COACH is already approved in United States for the following indications:

🇺🇸 Approved in United States as COACH for: