NCT06654323 The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity
| NCT ID | NCT06654323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Childhood Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2025-02-20 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * families for whom the primary care provider (PCP) or site principal investigator (PI) thinks the study and/or intervention is clinically/medically inappropriate (e.g. developmental delay, disordered eating, mobility impairments, cognitive or mental difficulties); * participant child is taking weight management medications at the time of enrollment; * participant child plans to undergo bariatric surgery or another weight loss operation during the 12-month study; or * participant caregiver-child dyad has plans to move during the 12-month study and will no longer be a patient of a participating clinic.
Contact & Investigator
William Heerman, MD MPH
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06654323 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06654323 currently recruiting?
Yes, NCT06654323 is actively recruiting participants. Contact the research team at filoteia.popescu@vumc.org for enrollment information.
Where is the NCT06654323 trial being conducted?
This trial is being conducted at Baton Rouge, United States, Nashville, United States.
Who is sponsoring the NCT06654323 clinical trial?
NCT06654323 is sponsored by Vanderbilt University Medical Center. The principal investigator is William Heerman, MD MPH at Vanderbilt University Medical Center. The trial plans to enroll 900 participants.
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