NCT06532747 Redefining BMI: The Body, Mind, and Inflammation Trial
| NCT ID | NCT06532747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2027-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-09-26 with a primary completion date of 2027-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Jessica LaRose
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT06532747 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 25 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06532747 currently recruiting?
Yes, NCT06532747 is actively recruiting participants. Contact the research team at huntervr@vcu.edu for enrollment information.
Where is the NCT06532747 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT06532747 clinical trial?
NCT06532747 is sponsored by Virginia Commonwealth University. The principal investigator is Jessica LaRose at Virginia Commonwealth University. The trial plans to enroll 32 participants.
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