What this study is
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.
What's being tested
- Integrated Lifestyle Intervention (ILI)
Intervention · 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
Intervention · 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
- Sponsor
- Virginia Commonwealth University
- Conditions
- Obesity · Adiposity
- Enrolling
- 32 people
- Starts
- 2025-09-26
- Est. completion
- 2027-03-03
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 25 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Ages 18-25 years
- Body mass index (BMI) 25-50 kg/m^2
- Female
You can't join 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
- Planning to move from the area within the study period
- Unwilling to be randomized to either study condition
- Unable to read and speak English
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVirginia Commonwealth Universtity
Richmond, Virginia, United States
- Vivian Hunter, MS · Contact804-628-3972huntervr@vcu.edu
- Jessica LaRose · Contact(804) 628-7521jlarose@vcu.edu
Recruiting
Study team
Sponsor
Virginia Commonwealth University
Study ID HM20028726
Principal investigator
Jessica LaRose
Virginia Commonwealth University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.