Recruiting

Obesity Interventions

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06546696

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

Interventions

Competency Based Approaches to Community Health (COACH)

Study Details

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.

Conditions

Childhood Obesity

Study ID

NCT06546696

Start date

Oct 23, 2024

Status verified date

Dec, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

William J Heerman, MD, MPH

615-322-7080Bill.Heerman@vumc.org

Laura Adams, RD, MBA

615-875-7298Laura.E.Adams@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

William J Heerman, MD, MPH

615-322-7080Bill.Heerman@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-12-11.