The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorVanderbilt University Medical Center

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

900 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

Pennington Biomedical Research Center

Collaborator