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RECRUITING
NCT06654323
NA

The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2025-02-20

Completion Date

2028-08-01

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Intensive Behavioral Lifestyle Modification

Participants in all arms will receive visits with their child's primary care provider (4 visits, 1 hour total), on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), and community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total). The difference between arms will be in the frequency and duration of personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session), 12 sessions (60 minutes per session), 9 sessions (60 minutes per session), 8 sessions (45 minutes per session), or 6 sessions (30 minutes per session).

Locations (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States