TrialX
Redefining BMI: The Body, Mind, and Inflammation Trial

Redefining BMI: The Body, Mind, and Inflammation Trial

Redefining BMI: The Body, Mind, and Inflammation Trial

Recruiting
18-25 years
Female
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This is a 2-arm, parallel randomized controlled pilot trial designed to test the preliminary efficacy of a novel integrated lifestyle intervention for emerging adult (EA) women, compared to a developmentally adapted behavioral weight loss arm. Thirty-two participants (female, 18-25 years, BMI 25-50 kg/m^2) will be randomized to 1 of 2 arms: 1) Integrated Lifestyle Intervention (ILI); or 2) Behavioral Weight Loss (BWL). The primary goals are to test the preliminary efficacy of ILI to reduce adiposity over 12 months compared to BWL, and to test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL. Assessments of adiposity, inflammatory cytokines, cardiovascular disease (CVD) risk factors, and behavioral and psychological treatment targets will occur at 0, 4, 8 and 12 months. In addition, putative psychological mechanisms of action will be explored to inform a future trial.

Study details
    Obesity
    Adiposity

NCT06532747

Virginia Commonwealth University

2 March 2026

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