NCT06654323 · Vanderbilt University Medical Center
The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Baton Rouge, Louisiana
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2025 · Source of record for eligibility and locations