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Redefining BMI: The Body, Mind, and Inflammation Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 25 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

VA