Body, Mind, and Inflammation program for 18–25-year-old women with higher BMI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.