Actively Recruiting
The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity
Led by Vanderbilt University Medical Center · Updated on 2025-09-08
900
Participants Needed
2
Research Sites
179 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
P
Pennington Biomedical Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana. The team is assigning children and their caregivers by chance to one of five groups. In the first group, 300 children and their caregivers receive 26 hours of IBT. In the second group, 300 children and their caregivers receive 13 hours of IBT. The remaining three groups of 100 children and their caregivers receive 16, 19, or 22 hours of IBT. Children's healthcare providers, nutritionists, and social workers are providing IBT to each of the groups over six months. At the start of the study and again after one year, the research team is measuring the children's body mass index, or BMI. BMI is a measure of a person's body fat based on their height and weight. The team is also looking at the children's: * Diet * Exercise * Sleep * Media use * Quality of life
CONDITIONS
Official Title
The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child has a BMI at or above the 95th percentile for age and sex based on CDC growth curves
- Parent or caregiver is 18 years or older
- Comfortable speaking and reading English or Spanish
- Is a patient at a participating clinical practice
- Able to provide written or verbal consent/assent
- Able to attend scheduled sessions during the 12-month study
- Willing to make behavioral and lifestyle changes
- Has internet access to join online intervention components
- Completes baseline data collection including child height and weight
- Completes at least 90% of baseline survey items within 14 days after the baseline visit
You will not qualify if you...
- Primary care provider or site investigator considers the study or intervention clinically or medically inappropriate (e.g., developmental delay, disordered eating, mobility or cognitive impairments)
- Child is currently taking weight management medications
- Child plans to have bariatric surgery or other weight loss operation during the 12-month study
- Caregiver-child pair plans to move and will no longer be a patient at a participating clinic during the 12-month study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
F
Filoteia Popescu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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