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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• BMI≥95th percentile for age and sex based on standardized CDC growth curves.

• parent/caregiver aged ≥ 18 years old

• are comfortable speaking and reading English or Spanish;

• are a patient of a participating clinical practice;

• are able to provide written or verbal consent/assent;

• are able to attend scheduled sessions in the 12-month study;

• are willing to make behavioral and lifestyle changes;

• are able to access the internet to participate in online intervention components;

• complete baseline data collection, including child height and weight; and

• complete at least 90% of baseline survey items no later than 14 days after the baseline visit.

Locations
United States
Louisiana
Pennington Biomedical Research Center
RECRUITING
Baton Rouge
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Filoteia Popescu
filoteia.popescu@vumc.org
615-322-7080
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 900
Treatments
Experimental: 26-hour intensive behavioral lifestyle intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session).
Active_comparator: 22-hour intensive behavioral lifestyle intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 12 sessions (60 minutes per session).
Active_comparator: 19-hour intensive behavioral lifestyle intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professiona for 9 sessions (60 minutes per session).
Active_comparator: 16-hour intensive behavioral lifestyle intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 8 sessions (45 minutes per session).
Active_comparator: 13-hour intensive behavioral lifestyle intervention
Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 6 sessions (30 minutes per session).
Related Therapeutic Areas
Sponsors
Collaborators: Pennington Biomedical Research Center
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov