Redefining BMI: The Body, Mind, and Inflammation Trial

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06532747
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 25 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 26, 2025
Status verified
May 2026
Primary completion
Mar 3, 2027
Completion
Mar 3, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Integrated 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. 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.
  • Experimental: Behavioral Weight Loss (BWL)
    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.

Primary Outcome Measure

To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity over 12 months compared with BWL [ Time Frame: Change in weight at 4, 8, and 12-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniverstityRichmondVirginia23298
Vivian Hunter, MS
[email protected]
804-628-3972
Jessica LaRose
[email protected]
(804) 628-7521

Find similar trials in Richmond, VA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Virginia Commonwealth Universtity· Richmond, VA

Related Studies