NCT06532747 · Virginia Commonwealth University
Redefining BMI: The Body, Mind, and Inflammation Trial
What this study is about
Emerging adulthood (18-25 years of age) is a critical developmental window to promote weight management and cardiometabolic health, particularly for emerging adult women.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ages 18-25 years
- Body mass index (BMI) 25-50 kg/m\^2
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
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations