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Behavioral Intervention

Lifestyle Intervention for Obesity

N/A
Waitlist Available
Led By Jessica LaRose
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female gender
Ages 18-25
Must not have
Medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis
Hospitalization for depression or other psychiatric disorder within the past 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 8, and 12-months
Awards & highlights
No Placebo-Only Group

Summary

"This trial focuses on young adults aged 18-25 years and the impact of obesity, stress, and psychological symptoms on their heart and metabolic health. The study shows that obesity rates have increased significantly in

Who is the study for?
This trial is for young women aged 18-25 with a BMI of 25-50, not currently pregnant or breastfeeding, without severe medical conditions affecting weight or inflammation. Participants must not be on weight loss programs or medications that affect weight/metabolism and should wear an activity tracker for at least 8 hours a day.
What is being tested?
The study tests how monitoring health with digital tools and an Integrated Lifestyle Intervention (ILI) can impact obesity-related inflammation in young adult women. It aims to improve cardiometabolic health by reducing chronic low-level inflammation.
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue. Psychological stress from lifestyle changes could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am between 18 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition affecting my hormone regulation.
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I have not been hospitalized for depression or any psychiatric disorder in the last year.
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I am currently participating in a weight loss program.
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I am currently taking medication to lose weight.
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I have a heart condition or experience chest pain or fainting.
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I have lost more than 5% of my body weight in the last 3 months.
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I have type 1 or type 2 diabetes.
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I have severe inflammation due to rheumatologic or gastrointestinal conditions.
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I have been diagnosed with bipolar or psychotic disorder.
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I am not willing to be randomly assigned to a study group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 8, and 12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 8, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing % body fat over 12 months compared with BWL
To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity over 12 months compared with BWL
To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing waist circumference over 12 months compared with BWL
Secondary study objectives
Change in cholesterol level at 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 ALT/AST at 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.
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Integrated Lifestyle Intervention (ILI)Experimental Treatment1 Intervention
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.
Group II: Behavioral Weight Loss (BWL)Experimental Treatment2 Interventions
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.

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Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,432 Previous Clinical Trials
4,323,209 Total Patients Enrolled
467 Trials studying Obesity
589,451 Patients Enrolled for Obesity
Virginia Commonwealth UniversityLead Sponsor
714 Previous Clinical Trials
22,888,459 Total Patients Enrolled
30 Trials studying Obesity
5,724 Patients Enrolled for Obesity
Jessica LaRosePrincipal InvestigatorVirginia Commonwealth University
~21 spots leftby Apr 2026
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