About this trial
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
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intensive Behavioral Lifestyle Modification
Treatment groups
Sponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
Pennington Biomedical Research Center
Collaborator