The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06546696
Status
Recruiting
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Conditions

  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Competency Based Approaches to Community Health (COACH) — BEHAVIORAL
    COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 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.

Study Details

Evidence-based obesity treatment is inaccessible to most children in the United States. This lack of access is a source of health inequity, whereby children from rural and minority communities, who have the highest rates of childhood obesity, are also the least likely to receive an evidence-based intervention. Developing strategies to improve access to evidence-based obesity interventions could reduce health disparities by improving reach to these underserved communities. The premise of this study is that using a systematic framework to adapt a community-based behavioral intervention for childhood obesity that accounts for individual, family, and community factors will increase reach and effectiveness among low-income, minority, and rural populations. COACH is a multi-level obesity intervention that supports 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by directly addressing parent weight loss and engaging parents as agents of change for their children, and 3) the community by building the capacity of local community centers to offer parent-child programming. The investigators propose testing the process of adapting COACH in a cluster-randomized trial.

Key Dates

Start date
Oct 23, 2024
Status verified
Dec 2025
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: COACH Intervention
    COACH intervenes at 3 levels: the individual child, the family, and the community. Child-Level Intervention Content: We will direct skill-building lessons toward the child at developmentally appropriate levels. Family-Level Intervention Content: Curricular components for parents are designed to leverage parents as agents of change for their children. As such, the group-based sessions includes realistic goal setting (SMART goals), strategies to navigate barriers, training in physical activity, and group-based accountability. During the session, parents and children will participate in a low to moderate physical activity. Community-Level Content: The intervention is delivered in the context of a widely available community resource, local community centers across Middle Tennessee. Online Platform: All participants will have access to an online on-demand health behavior change curriculum. Modules are self-paced and will take approximately 7 hours.
  • Active Comparator: Adaptation Arm
    The core components of the adaptation arm will mirror the COACH intervention arm. Each community center will be guided through a process of adapting the specific intervention content, and as such, will be unique to each of the 25 community centers randomized to this arm. In this way, the study tests the process of adapting the intervention, instead of a specific portfolio of adaptations.

Primary Outcome Measure

Child Percent of the 95th Body Mass Index Percentile [ Time Frame: 6 months post randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212
William J Heerman, MD, MPH
[email protected]
615-322-7080

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