Status:
RECRUITING
Redefining BMI: The Body, Mind, and Inflammation Trial
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Adiposity
Eligibility:
FEMALE
18-25 years
Phase:
NA
Brief 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 s...
Detailed Description
This is a 2-arm, parallel randomized controlled pilot trial designed to test the preliminary efficacy of a novel integrated lifestyle intervention for emerging adult (EA) women, compared to a developm...
Eligibility Criteria
Inclusion
- Ages 18-25 years
- Body mass index (BMI) 25-50 kg/m\^2
- Female
Exclusion
- Currently pregnant or lactating
- Current involvement in a weight loss program or current use of weight loss medication
- Lost \>5% of their body weight in the previous 3 months
- Uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity
- Diagnosis of type 2 diabetes and/or impaired fasting blood glucose
- Diagnosis of type 1 diabetes
- Rheumatologic and gastrointestinal conditions associated with severe systemic inflammation
- Medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis
- Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- Current or recent (during the past 3 months) use of medications that may impact weight or metabolic function
- Current or recent (during the past 3 months) use of anti-inflammatory medications
- Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- Uncontrolled bipolar disorder or psychotic disorder
- Current suicidal intent
- Planning to move from the area within the study period
- Unwilling to be randomized to either study condition
- Unable to read and speak English
Key Trial Info
Start Date :
September 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 3 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06532747
Start Date
September 26 2025
End Date
March 3 2027
Last Update
December 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth Universtity
Richmond, Virginia, United States, 23298