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Behavioral Intervention

Bright Bodies Program for Childhood Obesity

N/A
Recruiting
Led By Mahnoosh (Mona) Sharifi, MD, MPH
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months before and up to 15 months after enrollment
Awards & highlights

Study Summary

This trial will study how an intervention program can improve child obesity and how it impacts adoption, reach, fidelity, cost, & maintenance in 3 settings.

Who is the study for?
This trial is for children aged 8-12 with severe obesity (BMI ≥95th percentile) and their parents. It's not for kids who've had eating disorders, dramatic weight loss, are in another similar study or program, planning bariatric surgery soon, have conditions affecting eating or exercise abilities, cognitive impairments, or language barriers.Check my eligibility
What is being tested?
The Bright Bodies intervention is being tested to see if it helps reduce BMI in obese children while also checking how well the program works across different settings that serve patients affected by obesity.See study design
What are the potential side effects?
Since this trial involves a lifestyle intervention rather than medication, typical medical side effects aren't expected. However, participants may experience changes in mood or behavior due to diet and activity adjustments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months before and up to 15 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months before and up to 15 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in %BMIp95
Secondary outcome measures
Change in binge eating behaviors.
Change in parent BMI
Change in parent conversations about weight.
+3 more
Other outcome measures
Alanine Transaminase
Diastolic blood pressure
Change in hemoglobin A1c
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Bright Bodies

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,201 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,414 Total Patients Enrolled
Mahnoosh (Mona) Sharifi, MD, MPHPrincipal InvestigatorYale University
1 Previous Clinical Trials
240,772 Total Patients Enrolled

Media Library

Bright Bodies (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05595161 — N/A
Childhood Obesity Clinical Trial 2023: Bright Bodies Highlights & Side Effects. Trial Name: NCT05595161 — N/A
Bright Bodies (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05595161 — N/A
Childhood Obesity Research Study Groups: Intervention

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still underway for this clinical research?

"Affirmative. Details hosted on clinicaltrials.gov reveal that this trial, which was initially listed on October 11th 2022 is presently looking for participants. 360 individuals are needed for the three sites involved in the study."

Answered by AI

What is the scope of enrollees in this research project?

"This clinical trial necessitates the enrollment of 360 qualified patients, who have fulfilled all specified inclusion criteria. Participating in this medical research can be done at various locations, such as University of Alabama at Birmingham and University of California San Francisco."

Answered by AI

Is enrollment for this investigation currently open?

"This medical trial is recruiting 360 minors aged 8 to 12 who have been identified with obesity. To qualify, they must satisfy the criteria of having a BMI equal or greater than 95th percentile and be enrolled in an intervention programme alongside their parent/guardian."

Answered by AI

Does the enrollment criterion of this clinical trial extend to individuals aged 25 and above?

"This study has a specified age range of 8 to 12 years, as detailed in the enrollment conditions."

Answered by AI

Who else is applying?

What state do they live in?
Maine
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
Maine Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity
2022. "Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05595161.
~120 spots leftby Nov 2025
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