Evaluating the effectiveness of different intensities of behavioral interventions for childhood obesity

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

This study is testing how different amounts of support for healthy habits can help children aged 5-17 with obesity feel better and improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 2 sites (Baton Rouge, Louisiana and 1 other locations)
• Trial ID: NCT06654323 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the optimal number of hours for intensive behavioral lifestyle interventions in treating childhood obesity among children aged 5-17. A total of 900 children will be randomly assigned to receive varying doses of intervention, ranging from 13 to 26 hours, over a six-month period. The study will assess changes in body mass index (BMI), diet, exercise, sleep, media use, and quality of life before and after the intervention. The research focuses on rural and minority populations in Tennessee and Louisiana, integrating the intervention into local pediatric primary care practices.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 5-17 with obesity, defined as having a BMI at or above the 95th percentile for their age and sex.

Not a fit: Patients with developmental delays, disordered eating, mobility impairments, or other medical conditions deemed inappropriate for the intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective, resource-efficient interventions for childhood obesity, potentially improving health outcomes for children.

How similar studies have performed: Previous studies have shown varying success with behavioral interventions for childhood obesity, but this specific approach of testing different intervention intensities is relatively novel.

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.

Where this trial is running

Baton Rouge, Louisiana and 1 other locations

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: William Heerman, MD MPH — Vanderbilt University Medical Center
• Study coordinator: Filoteia Popescu

Conditions Childhood Obesity; Behavioral Intervention; Rural and Urban Populations; Racial and Ethnic Minority Populations; Nutrition Counseling; Community Resource Counseling