Redefining BMI: The Body, Mind, and Inflammation Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorVirginia Commonwealth University

About this trial

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

Qualifiers

Ages 18-25 years

Body mass index (BMI) 25-50 kg/m²

Female

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Integrated Lifestyle Intervention (ILI)
  • Monitoring with digital tools

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

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

Collaborator