Adapting obesity interventions for children in community settings
The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings
This study is testing a new version of a family-focused program to help children in underserved communities manage their weight better and see if it works better than the original program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06546696 on ClinicalTrials.gov |
What this trial studies
This trial aims to improve access to evidence-based obesity interventions for children from underserved communities, particularly in rural and minority populations. The study will adapt a community-based behavioral intervention called COACH, which focuses on both the child and their family, to better fit the needs of these communities. It involves a community readiness assessment followed by a cluster-randomized trial to compare the effectiveness of the adapted intervention against the original program. The goal is to create a scalable solution that can be implemented across various community centers in the U.S.
Who should consider this trial
Good fit: Ideal candidates include children aged 6 to 12 years with a body mass index at or above the 95th percentile, along with their parents or guardians who are committed to participating.
Not a fit: Children with developmental disorders affecting metabolism or behaviors that limit participation in physical activities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce childhood obesity rates in underserved populations, leading to improved health outcomes.
How similar studies have performed: Other studies have shown promise in adapting interventions for health disparities, making this approach both innovative and grounded in prior success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Child with an age ≥ 6 years and \< 12 years * Child body mass index ≥95th percentile for age and sex on standardized CDC growth curves * Index parent/legal guardian with an age ≥18 years * Parent and child speak English or Spanish * Family resides within or frequently visit selected zip codes within Middle TN surrounding the partnering community centers; * Have parental commitment to participate in a 6-month study; * Have the ability to view online trainings * Complete baseline data collection, including parent and child height and weight and at least 90% of baseline survey items. Exclusion Criteria: * Participant child has been diagnosed with Down Syndrome, Autism, or any other developmental disorders that impact metabolism or behaviors that would preclude participation in group physical activity settings; * Either the participant caregiver or child is unable to participate in light to moderate physical activity; * Participant caregiver has a serious mental or neurologic illness that impairs ability to consent/participate.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: William J Heerman, MD, MPH
- Email: Bill.Heerman@vumc.org
- Phone: 615-322-7080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.