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Redefining BMI: The Body, Mind, and Inflammation 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.

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Detailed Description

This is a 2-arm, parallel randomized controlled pilot trial designed to test the preliminary efficacy of a novel integrated lifestyle intervention for emerging adult (EA) women, compared to a developmentally adapted behavioral weight loss arm. Thirty-two participants (female, 18-25 years, BMI 25-50 kg/m^2) will be randomized to 1 of 2 arms: 1) Integrated Lifestyle Intervention (ILI); or 2) Behavioral Weight Loss (BWL). The primary goals are to test the preliminary efficacy of ILI to reduce adiposity over 12 months compared to BWL, and to test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL. Assessments of adiposity, inflammatory cytokines, cardiovascular disease (CVD) risk factors, and behavioral and psychological treatment targets will occur at 0, 4, 8 and 12 months. In addition, putative psychological mechanisms of action will be explored to inform a future trial.

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What sex were you assigned at birth, on your original birth certificate?

Why do we ask this? We ask for your assigned sex at birth because we are supporting clinical trials that require this information. For example, scientists may need to understand how a study drug works differently in those who were assigned female or male at birth. We do understand that "male" and "female" don't reflect the full range of possible genders. We will continue to monitor and update our screening questions as new research is conducted and needs change.

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Age

18 - 25

Gender

Female

NCT ID

NCT06532747

Phase

-1

Status

Recruiting Now

Medical Condition

adiposity

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Medical Condition

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The Study

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About Clinical Trials

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Your Journey

Receiving the medication

You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.

Visiting the study site

Study participation involves approximately 8 visits to your local study center over 6 to 7 months.

Follow-up

There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.