The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity
Recruiting · NCT06654323 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanderbilt University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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
Who can take part
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 it is running
2 locations listed across 2 US states.
- Pennington Biomedical Research Center - Baton Rouge, Louisiana, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States