Actively Recruiting
A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program
Led by University of Pittsburgh · Updated on 2025-06-18
205
Participants Needed
3
Research Sites
165 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine the physiological basis for the differences in weight regain among adults (25-59 years old) with obesity following participation in a behavioral weight loss program. Eligible participants will undergo a baseline evaluation after which they will enter an up to 20 week behavioral weight loss program with the goal of losing at least 7 percent of their baseline weight within 35 weeks. Participants who meet the weight loss goal will be asked to remain weight stable for 2 weeks after which they will undergo a clinical examination. They will then be observed for 1 year during which they will undergo 2 additional clinical examinations, one 4 months after completing the weight loss program, and the other 12 months after completing the weight loss program.
CONDITIONS
Official Title
A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 25 and less than 60 years
- Body mass index (BMI) between 30 and less than 40 kg/m2 at the first screening visit
- Weight stable within 5% of current weight for the past 6 months at the first screening visit
- Ability to participate in ergometry (exercise) testing
- Access to a smartphone, tablet, or computer with internet
You will not qualify if you...
- For ages 25-29, more than 5% deviation from maximum weight since age 25 (excluding pregnancy weights)
- For ages 30 and above, more than 5% deviation from maximum weight in the last 5 years or 10% deviation since age 30 (excluding pregnancy weights)
- History of pulmonary embolus in the past 6 months
- Cardiovascular disease in the past 6 months (e.g., heart attack, stroke, unstable angina, or transient ischemic attack)
- Current or recent major depressive disorder within 2 years
- Regular tobacco or nicotine use in the past year
- Currently engaged in intense physical training or training for sports events
- Currently pregnant, less than one year postpartum, or planning pregnancy within 2 years
- New York Heart Association Class II or greater heart condition or dysrhythmia
- Diabetes or use of glucose-lowering medication
- Thyroid disease requiring medication or abnormal thyroid hormone levels
- Renal disease requiring dialysis
- Known HIV infection
- Elevated liver enzymes or active gall bladder disease
- Significant anemia or low platelet count
- Low white blood cell counts as defined by specific criteria
- Active cancer or cancer treatment in past 5 years except non-melanoma skin cancers
- Eating disorders including anorexia nervosa, bulimia nervosa, or binge eating disorder
- Severe psychiatric disorders such as schizophrenia or bipolar disorder
- Unwillingness to abstain from marijuana/cannabis use for 3 weeks at assessment times
- Known or suspected substance abuse
- Recent antiretroviral therapy including HIV treatment or prophylaxis
- Use of medications affecting appetite, energy expenditure, or weight
- Use of anticoagulant medication
- Enrollment in another supervised weight loss program
- Prior or planned bariatric or obesity device surgery or procedures
- Severely restricted diets such as vegan, very low carbohydrate or fat, or strict gluten-free
- Diagnosed gluten intolerance or inflammatory bowel disease requiring special diet
- Night or rotating shift work
- Known severe food allergies
- Blood pressure outside specified ranges or abnormal heart rate
- Metal implants or tattoos that interfere with assessments
- Inability to fit in DXA scanning field of view
- Allergies to lidocaine or acetaminophen
- Non-compliance with study tasks during screening
- Blood clotting disorders
- Tendency to form thick or raised scars
- Inability to maintain weight stability prior to baseline assessment
- High risk for suicide based on assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
2
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Andrew Pelesko, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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