Redefining BMI: The Body, Mind, and Inflammation Trial

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Adiposity; Obesity

Treatments: Behavioral: Monitoring with digital tools; Behavioral: Integrated Lifestyle Intervention (ILI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06532747

HM20028726

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Integrated Lifestyle Intervention (ILI)

Experimental group

Description:

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. 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.

Treatment:

Behavioral: Integrated Lifestyle Intervention (ILI)

Behavioral Weight Loss (BWL)

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated Lifestyle Intervention (ILI)

Behavioral: Monitoring with digital tools