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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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
• Email: filoteia.popescu@vumc.org
• Phone: 615-322-7080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.