RECRUITING

Redefining BMI: The Body, Mind, and Inflammation Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Redefining BMI: The Body, Mind, and Inflammation Trial

Quick Facts

Study Start:2025-09
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06532747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 25 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18-25 years
  2. * Body mass index (BMI) 25-50 kg/m\^2
  3. * Female
  1. * Currently pregnant or lactating
  2. * Current involvement in a weight loss program or current use of weight loss medication
  3. * Lost \>5% of their body weight in the previous 3 months
  4. * Uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity
  5. * Diagnosis of type 2 diabetes and/or impaired fasting blood glucose
  6. * Diagnosis of type 1 diabetes
  7. * Rheumatologic and gastrointestinal conditions associated with severe systemic inflammation
  8. * Medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis
  9. * Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  10. * Current or recent (during the past 3 months) use of medications that may impact weight or metabolic function
  11. * Current or recent (during the past 3 months) use of anti-inflammatory medications
  12. * Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months
  13. * Hospitalization for depression or other psychiatric disorder within the past 12 months
  14. * Uncontrolled bipolar disorder or psychotic disorder
  15. * Current suicidal intent
  16. * Planning to move from the area within the study period
  17. * Unwilling to be randomized to either study condition
  18. * Unable to read and speak English

Contacts and Locations

Study Contact

Morgan Meyer
CONTACT
(804) 527-4759
morgan.meyer@vcuhealth.org
Jessica LaRose
CONTACT
(804) 628-7521
jlarose@vcu.edu

Principal Investigator

Jessica LaRose
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth Universtity
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Jessica LaRose, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2026-04

Study Record Updates

Study Start Date2025-09
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • BMI
  • Emerging Adult (EA) Women
  • Lifestyle Intervention
  • Biomarker Inflammation Improvement

Additional Relevant MeSH Terms

  • Obesity
  • Adiposity