Redefining BMI: The Body, Mind, and Inflammation Trial

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    32
  • sponsor
    Virginia Commonwealth University
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Updated on 2 March 2026
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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.

Description

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.

Details
Condition Obesity, Adiposity
Age 18years - 25years
Clinical Study IdentifierNCT06532747
SponsorVirginia Commonwealth University
Last Modified on2 March 2026

Eligibility

 Yes No Not Sure

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
Clear my responses
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