Redefining BMI: The Body, Mind, and Inflammation Trial

Recruiting now · Not applicable

Conditions studied: Obesity, Adiposity

In brief

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 facts

Study ID

NCT06532747

Run by

Virginia Commonwealth University

People needed

32

Starts

2025-09-26

Expected to finish

2027-03-03

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 25. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-25 years
• Body mass index (BMI) 25-50 kg/m\^2
• Female

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth Universtity — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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