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Behavioural Intervention

COACH for Childhood Obesity

N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child body mass index ≥95th percentile for age and sex on standardized CDC growth curves
Child with an age ≥ 6 years and < 12 years
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post randomization
Awards & highlights

Summary

"This trial aims to improve access to evidence-based obesity treatment for children in underserved communities. They will adapt a community-based intervention called COACH to include individual, family, and community factors. The goal

Who is the study for?
This trial is for children with obesity, particularly from low-income, minority, and rural communities who often lack access to evidence-based treatments. It aims to include families in the intervention process.
What is being tested?
The ADAPT Trial is testing COACH, a community health approach that supports obese children through health education, involves parents in weight loss and as change agents for their kids, and empowers local centers to offer programs.
What are the potential side effects?
Since COACH is a behavioral intervention focusing on lifestyle changes rather than medication or medical procedures, it may not have direct side effects. However, participants might experience stress or frustration related to new diet or exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child's BMI is in the top 5% for their age and sex.
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My child is between 6 and 11 years old.
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My parent or legal guardian is 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My child has a condition like Down Syndrome or Autism affecting their ability to join in group activities.
Select...
Either I or my child cannot do light to moderate exercise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Child Percent of the 95th Body Mass Index Percentile
Other study objectives
Child Diet
Child Media Use
Child Physical Activity
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: COACH InterventionExperimental Treatment1 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 II: Adaptation ArmActive Control1 Intervention
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.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,184 Total Patients Enrolled
~500 spots leftby Dec 2028
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