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RECRUITING
NCT06532747
NA

Redefining BMI: The Body, Mind, and Inflammation Trial

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

Summary

Emerging adulthood (18-25 years of age) is a critical developmental window to promote weight management and cardiometabolic health, particularly for emerging adult women. The primary purpose of this study is to test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity, as well as improving biomarkers of inflammation and metabolic risk over 12 months compared with a traditional behavioral weight loss intervention. This treatment program will be tested in emerging adult (EA) women ages 18-25 years old with a BMI of 25-50 kg/m\^2.

Key Details

Gender

FEMALE

Age Range

18 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-09-26

Completion Date

2027-03-03

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

BEHAVIORAL

Integrated Lifestyle Intervention (ILI)

ILI participants will receive training in empirically supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with BWL content adapted to meet the needs of EAs.

BEHAVIORAL

Monitoring with digital tools

All participants will receive digital tools to facilitate self-monitoring-the initial 4-month program will consist of group sessions via Zoom (8 weekly, 4 bi-weekly) with weekly tailored e-coaching, followed by monthly boosters through 12 months.

Locations (1)

Virginia Commonwealth Universtity

Richmond, Virginia, United States