NCT06532747Recruiting
Redefining BMI: The Body, Mind, and Inflammation Trial
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 26 Sept 2025
- Primary completion date
- 3 Mar 2027
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Obesity
- NCT number
- NCT06532747
What you commit to
- Study type: Interventional
- Planned participants: 32
- From 26 Sept 2025 to the primary completion date, 3 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity
- 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
- Hospitalization for depression or other psychiatric disorder within the past 12 months
- Uncontrolled bipolar disorder or psychotic disorder
- Unwilling to be randomized to either study condition
Lab values
- Diagnosis of type 2 diabetes and/or impaired fasting blood glucose
Other
- Currently pregnant or lactating
- Current suicidal intent
- Planning to move from the area within the study period
- Unable to read and speak English
Who the study is looking for
- Ages 18-25 years
- Body mass index (BMI) 25-50 kg/m\^2
- Female
Age in the registry: 18 years to 25 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth Universtity Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.