Recruiting

Intensive Lifestyle Intervention

Sponsor:

Virginia Commonwealth University

Code:

NCT06532747

Conditions

Obesity

Adiposity

Eligibility Criteria

Sex: Female

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Integrated Lifestyle Intervention (ILI)

Monitoring with digital tools

Study Details

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

Study ID

NCT06532747

Start date

Sep 26, 2025

Status verified date

May, 2026

Completion date

Mar 3, 2027

Anticipated

Primary completion date

Mar 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

Monitoring with digital tools

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 ]
  • To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing waist circumference over 12 months compared with BWL [ Time Frame: 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 [ Time Frame: Change in % body fat at 4, 8, and 12-months. ]

Central Contacts and Locations

Central contacts

Vivian Hunter

(804) 628-3972huntervr@vcu.edu

Jessica LaRose

(804) 628-7521jlarose@vcu.edu

Locations

Virginia Commonwealth Universtity

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Vivian Hunter, MS

804-628-3972huntervr@vcu.edu

Jessica LaRose

(804) 628-7521jlarose@vcu.edu

More Information

Sponsor

Virginia Commonwealth University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-05-06.