Redefining BMI: The Body, Mind, and Inflammation Trial

This study, called "Redefining BMI: The Body, Mind, and Inflammation Trial," is looking at new ways to help young women manage their weight and improve their health. It's testing two different approaches: an Integrated Lifestyle Intervention (ILI) and a traditional Behavioral Weight Loss (BWL) program. The ILI program teaches strategies to improve psychological function and change behaviors linked to inflammation. Both programs use digital tools for self-monitoring and involve group sessions and e-coaching. The study aims to see if the ILI is better at reducing body fat, weight, and waist size over 12 months. You might be able to join if you are a woman between 18 and 25 years old with a Body Mass Index (BMI) between 25 and 50 kg/m^2. The current status of the study is unclear.

Study design
This is a pilot study with 32 participants, divided into two groups by chance (randomized). It compares two different lifestyle interventions.
What's involved
You would participate in an initial 4-month program with weekly group sessions and e-coaching, followed by monthly booster sessions through 12 months. Assessments will occur at 0, 4, 8, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06532747

Redefining BMI: The Body, Mind, and Inflammation Trial

Recruiting
NAAges 18–25InterventionalPrevention
Virginia Commonwealth University
~32 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Integrated Lifestyle Intervention (ILI)Monitoring with digital tools

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity over 12 months compared with BWL
Measured over Change in weight at 4, 8, and 12-months
+2 more outcomes measured
Obesity
Adiposity
1 sites across 1 states
Virginia1
  • Jessica LaRose · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

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Eligibility criteria

Inclusion

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

Exclusion

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
  • To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity over 12 months compared with BWLChange in weight at 4, 8, and 12-months

    Change in adiposity (weight) between the two treatment arms across 12-months

  • To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing waist circumference over 12 months compared with BWLChange in waist circumference at 4, 8, and 12-months.

    Change in adiposity (waist circumference) between the two treatment arms across 12-months

  • To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing % body fat over 12 months compared with BWLChange in % body fat at 4, 8, and 12-months.

    Change in adiposity (% body fat) between the two treatment arms across 12-months