RecruitingNot ApplicableNCT06532747

Redefining BMI: The Body, Mind, and Inflammation Trial

Sponsor

Virginia Commonwealth University

Enrollment

32 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Adiposity

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 25 Years

Inclusion Criteria3

Ages 18-25 years
Body mass index (BMI) 25-50 kg/m\^2
Female

Exclusion Criteria18

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

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Interventions

BEHAVIORALIntegrated Lifestyle Intervention (ILI)

ILI participants will receive training in empirically supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with BWL content adapted to meet the needs of EAs.

BEHAVIORALMonitoring with digital tools

All participants will receive digital tools to facilitate self-monitoring-the initial 4-month program will consist of group sessions via Zoom (8 weekly, 4 bi-weekly) with weekly tailored e-coaching, followed by monthly boosters through 12 months.