Body, Mind, and Inflammation program for 18–25-year-old women with higher BMI
Redefining BMI: The Body, Mind, and Inflammation Trial
This trial will test whether an integrated lifestyle program combining diet, activity, and mental-health strategies helps women aged 18–25 with BMI 25–50 kg/m^2 lose body fat and reduce inflammation more than a standard weight-loss approach over 12 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | Female |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06532747 on ClinicalTrials.gov |
What this trial studies
This is a randomized, two-arm pilot enrolling 32 women aged 18–25 with BMI 25–50 kg/m^2 to compare an Integrated Lifestyle Intervention (ILI) with a developmentally adapted Behavioral Weight Loss (BWL) program. Participants will be randomized to ILI or BWL and followed for 12 months with assessments at baseline, 4, 8, and 12 months. Primary outcomes are changes in adiposity and inflammatory and cardiometabolic biomarkers, with behavioral and psychological targets measured as secondary outcomes. The trial will also explore psychological mechanisms of action to inform a future larger trial.
Who should consider this trial
Good fit: Women aged 18–25 with BMI 25–50 kg/m^2 who are not pregnant or lactating, not currently in another weight-loss program, and without uncontrolled medical conditions or diabetes are the ideal candidates.
Not a fit: People with type 1 or type 2 diabetes, recent >5% weight loss, major inflammatory or HPA-axis–altering medical conditions, current use of weight- or inflammation-affecting medications, or who are pregnant or lactating are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could produce greater fat loss and lower inflammatory and cardiometabolic risk in emerging adult women than standard behavioral weight-loss methods.
How similar studies have performed: Behavioral weight-loss programs have demonstrated benefits in adults, but an integrated body–mind–inflammation approach specifically for emerging adult women is relatively novel and has not been tested in large-scale trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 18-25 years * Body mass index (BMI) 25-50 kg/m\^2 * Female Exclusion Criteria: * 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 this trial is running
Richmond, Virginia
- Virginia Commonwealth Universtity — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jessica LaRose — Virginia Commonwealth University
- Study coordinator: Vivian Hunter
- Email: huntervr@vcu.edu
- Phone: (804) 628-3972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.