Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity

Completed · Not applicable

Conditions studied: Obesity, Childhood

In brief

This study will evaluate the effectiveness of the Bright Bodies intervention in improving body mass index (BMI) among 7-13 year-old children with obesity simultaneously with the impact of the implementation strategy on adoption, reach, fidelity, cost, and maintenance of the intervention in three heterogenous settings serving patients disproportionately affected by obesity.

Key facts

Study ID

NCT05595161

Run by

Yale University

People needed

184

Starts

2022-10-11

Expected to finish

2026-01-08

Last updated by the study team

2026-05-15

Who can join

Age: 7 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children ages 7-13 years with BMI ≥85th percentile and their parents;
• Child-parent dyads enrolled in the Bright Bodies intervention at each site will be eligible for inclusion in the evaluation study.

You may not qualify if…

• Children and/or parents who do not speak the language in which the program will be delivered at each site;
• Children and/or parents who plan to move away from the area within the next 15 months;
• Children with a history of purging and/or dramatic weight loss prior to the trial;
• Children who are currently participating in another high-intensity lifestyle intervention or other similar research study, or are planning to have bariatric surgery within the next six months
• Children whose EHR data cannot be accessed by the study teams;
• Children with chronic medical conditions limiting their ability to take food by mouth (e.g., g-tube fed, total parenteral nutrition), participate in physical activity (e.g., wheelchair bound), or meaningfully participate in group sessions (e.g., cognitive impairment);
• Children with a sibling enrolled in the trial
• Children who join the Bright Bodies program after the 4th week of a session (not including orientation)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Francisco — San Francisco, California, United States
• Maine Medical Center — Portland, Maine, United States

Full record on ClinicalTrials.gov

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