Redefining BMI: The Body, Mind, and Inflammation Trial

NCT06532747 | Recruiting

• 2 other identifiers: HM200287265R01DK137998
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Adiposity

Keywords

BMI; Emerging Adult (EA) Women; Lifestyle Intervention; Biomarker Inflammation Improvement

Outcome Measures

Primary Outcomes (3)

• To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity over 12 months compared with BWL

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

  Change in weight at 4, 8, and 12-months

• To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing waist circumference over 12 months compared with BWL

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

  Change in waist circumference at 4, 8, and 12-months.

• To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing % body fat over 12 months compared with BWL

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

  Change in % body fat at 4, 8, and 12-months.

Secondary Outcomes (8)

• To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in serum IL-1β and IL-6 at 4, 8, and 12-months.

  4, 8, and 12-months

• To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in serum TNF-α at 4, 8, and 12-months.

  4, 8, and 12-months

• To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in CRP at 4, 8, and 12-months.

  4, 8, and 12-months

• To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in free cortisol at 4, 8, and 12-months.

  4, 8, and 12-months

• To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in HOMA-IR at 4, 8, and 12-months

  4, 8, and 12-months

Study Arms (2)

Integrated Lifestyle Intervention (ILI)

EXPERIMENTAL

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.

Behavioral: Integrated Lifestyle Intervention (ILI)

Behavioral Weight Loss (BWL)

EXPERIMENTAL

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.

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

Interventions

Integrated Lifestyle Intervention (ILI) BEHAVIORAL

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.

Behavioral Weight Loss (BWL); Integrated Lifestyle Intervention (ILI)

Monitoring with digital tools BEHAVIORAL

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.

Behavioral Weight Loss (BWL)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Virginia Commonwealth Universtity

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica LaRose

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian Hunter

CONTACT

(804) 628-3972; huntervr@vcu.edu

Jessica LaRose

CONTACT

(804) 628-7521; jlarose@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: September 26, 2025
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)