Childhood ObesityNCT06546696
The ADAPT Trial: Adapting Evidence-Based Obesity Interventions in Community Settings
A study testing Competency Based Approaches to Community Health (COACH) in people with Childhood Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Competency Based Approaches to Community Health (COACH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to 1 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
William J Heerman, MD, MPH, 615-322-7080, Bill.Heerman@vumc.org
About this study
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.
Read the 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
- Being tested
- Competency Based Approaches to Community Health (COACH)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Competency Based Approaches to Community Health (COACH)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| COACH Intervention | Experimental | 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. Receives: Behavioral: Competency Based Approaches to Community Health (COACH) |
| Adaptation Arm | Active comparator | 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. Receives: Behavioral: Competency Based Approaches to Community Health (COACH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Percent of the 95th Body Mass Index Percentile
Calculated from CDC growth curves
Measured: 6 months post randomization
Secondary outcomes (1)
Child Percent of the 95th Body Mass Index Percentile
Calculated from CDC growth curves
Measured: 6 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start23 Oct 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is cluster-randomized trial, where we anticipate randomizing 50 community centers and enrolling 750 children (15/center).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bill Heerman, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546696
- Sponsor's protocol ID
- 241092
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Following the study's conclusion, aggregate data may be made available based on reasonable request. We will plan to upload a de-identified dataset to the NHLBI BioLINCC database (this upload also includes study protocols).