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

NCT ID: NCT06546696

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-23
• Study Completion Date: 2028-12-01

Brief Summary

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.

Detailed Description

In Aim 1, the investigators will conduct a community readiness assessment for COACH in 50 community centers serving rural, minority, and low-income families in middle TN. In 25 randomly selected community centers, the investigators will use a systematic process to adapt the intervention protocol based on the assessment results, while maintaining fidelity to COACH's core components. In Aim 2, in a cluster-randomized trial, the investigators will test the comparative effectiveness of each implementation strategy (adaptation vs. original program) on the implementation outcomes of reach, adoption, implementation, and maintenance. In Aim 3, the investigators will test the comparative effectiveness of the adapted and original intervention.

This research is innovative because it uses adaptation science as a potential solution to reduce health disparities in childhood obesity. By testing this intervention in a community resource available to 230 million Americans (community centers), the investigators aim to create a scalable obesity intervention that could be implemented in traditionally underserved populations across the country. This study will also develop and test a theory-based process for adapting behavioral interventions for both obesity and other health outcomes among diverse rural and urban communities.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Competency Based Approaches to Community Health (COACH)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Competency Based Approaches to Community Health (COACH)

Intervention Type: 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.

Interventions

Competency Based Approaches to Community Health (COACH)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

COACH

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bill Heerman

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

William J Heerman, MD, MPH

Role: CONTACT

Bill.Heerman@vumc.org

615-322-7080

Laura Adams, RD, MBA

Role: CONTACT

Laura.E.Adams@vumc.org

615-875-7298

Facility Contacts

William J Heerman, MD, MPH

Role: primary

Bill.Heerman@vumc.org

615-322-7080

Other Identifiers

241092

Identifier Type: -

Identifier Source: org_study_id