Actively Recruiting

Phase Not Applicable
Age: 18Years - 25Years
FEMALE
NCT06532747

Redefining BMI: The Body, Mind, and Inflammation Trial

Led by Virginia Commonwealth University · Updated on 2026-05-06

32

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

V

Virginia Commonwealth University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Redefining BMI: The Body, Mind, and Inflammation Trial

Who Can Participate

Age: 18Years - 25Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18-25 years
  • Body mass index (BMI) 25-50 kg/m²
  • Female
Not Eligible

You will not qualify if you...

  • Currently pregnant or lactating
  • Currently involved in a weight loss program or using weight loss medication
  • Lost more than 5% of body weight in the past 3 months
  • Uncontrolled medical conditions posing safety risks with diet or physical activity
  • Diagnosis of type 1 or type 2 diabetes or impaired fasting blood glucose
  • Rheumatologic or gastrointestinal conditions causing severe systemic inflammation
  • Medical conditions affecting the hypothalamic-pituitary-adrenal axis
  • History of heart conditions, chest pain, or loss of consciousness
  • Use of medications impacting weight or metabolism within past 3 months
  • Use of anti-inflammatory medications within past 3 months
  • Diagnosis or history of Anorexia Nervosa or Bulimia Nervosa or compensatory behaviors in past 3 months
  • Hospitalization for depression or psychiatric disorder within past 12 months
  • Uncontrolled bipolar or psychotic disorder
  • Current suicidal intent
  • Planning to move away during the study period
  • Unwillingness to be randomized to either study group
  • Unable to read and speak English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth Universtity

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

V

Vivian Hunter

CONTACT

J

Jessica LaRose

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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