NCT06654323Recruiting
The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 2 Oct 2024
- Start date
- 20 Feb 2025
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Obesity
- NCT number
- NCT06654323
What you commit to
- Study type: Interventional
- Planned participants: 900
- From 20 Feb 2025 to the primary completion date, 1 Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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 caregiver-child dyad has plans to move during the 12-month study and will no longer be a patient of a participating clinic.
Who the study is looking for
- 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.
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.