Redefining BMI: The Body, Mind, and Inflammation Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 25
Healthy Volunteers: f
View:

• Ages 18-25 years

• Body mass index (BMI) 25-50 kg/m\^2

• Female

Locations
United States
Virginia
Virginia Commonwealth Universtity
RECRUITING
Richmond
Contact Information
Primary
Morgan Meyer
morgan.meyer@vcuhealth.org
(804) 527-4759
Backup
Jessica LaRose
jlarose@vcu.edu
(804) 628-7521
Time Frame
Start Date: 2025-09-26
Estimated Completion Date: 2026-04
Participants
Target number of participants: 32
Treatments
Experimental: 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.~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.
Experimental: Behavioral Weight Loss (BWL)
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov