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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Oct 22, 2024

Keywords

ClinConnect Summary

The Dose Trial is a research study aimed at helping children aged 5 to 17 who are dealing with obesity. The study will involve 900 children from Tennessee and Louisiana, who will be randomly assigned to one of five groups. Each group will participate in a program called Intensive Behavioral Therapy (IBT) for different amounts of time: 26 hours, 13 hours, or between 16 to 22 hours over six months. The goal is to see how different levels of support can help improve children's weight and overall health. The researchers will measure the children's body mass index (BMI), which helps indicate body fat based on height and weight, along with other important factors like their diet, exercise, sleep, and quality of life both at the start of the study and one year later.

To be part of this study, children must have a BMI that is higher than 95% of their peers for their age and sex, and their parents or caregivers need to be at least 18 years old and comfortable speaking and reading in English or Spanish. Participants should also be willing to attend sessions for the full year and make some lifestyle changes. However, children with certain health issues or those taking weight management medications cannot participate. If you’re interested in helping your child with obesity and meeting these requirements, this study could be a great opportunity for support and learning.

Gender

ALL

Eligibility criteria

• 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.