A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program

Recruiting now · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT05748158

Run by

University of Pittsburgh

People needed

205

Starts

2023-09-29

Expected to finish

2027-03-01

Last updated by the study team

2026-06-12

Who can join

Age: 25 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 25 - <60 years
• BMI: 30 - <40 kg/m2 at the first screening visit
• Within 5% of current weight, for the past 6 months at the first screening visit
• Able to participate in ergometry testing
• Has a smart phone, tablet or computer with access to the internet

You may not qualify if…

• If 25-29 years old, > 5% deviation from maximum weight (excluding weights while pregnant) since age 25 years
• If at least 30 years old, > 5% deviation from maximum weight (excluding weights while pregnant) in last 5 years or ≥ 10% deviation from maximum weight (excluding weights while pregnant) since age 30 years
• History of pulmonary embolus in the past 6 months
• Cardiovascular disease (e.g. myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack) within the past 6 months
• Current major depressive disorder or history of major depressive disorder within 2 years
• Any regular tobacco or nicotine use in the past year
• Currently engaging in intense physical training or training for a sports event including, but not limited to, a marathon or body building
• Currently pregnant, or less than one-year post-partum or actively planning to become pregnant within the next two years
• Presently classified as being in New York Heart Association Class II or greater or dysrhythmia
• Diabetes (type 1 or 2 - HbA1c ≥ 6.5%, fasting glucose ≥ 126 mg/dL) or currently taking a glucose lowering medication
• Thyroid disease requiring hormones or medication or TSH < 0.5 or > 5 mIU/L
• Renal disease requiring dialysis
• Known HIV infection
• ALT or AST greater than 5 times the upper limit of normal or active gall bladder disease
• Significant anemia (Hgb < 10 g/dL) or thrombocytopenia (platelet count < 60,000 /mm3)
• Leukopenia defined as:
• Males: WBC < 3,100 /mm3 or (WBC 3,100 - < 4,000 /mm3 and at least 1 Duffy antigen (A, B) positive or no result) Females: WBC < 3,400 /mm3 or (WBC 3,400 - < 4,000 /mm3 and at least 1 Duffy antigen (A, B) positive or no result)
• Active cancer or current chemotherapy treatment, or history of cancer requiring treatment in the past 5 years except for non-melanoma skin cancers or cancers that have clearly been cured
• Current or past history of anorexia nervosa or bulimia nervosa
• Current or past diagnosis of binge eating disorder
• Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
• Unwillingness to abstain from marijuana/cannabis use for 3 weeks at each of the four assessment time points
• Known or suspected abuse or misuse of alcohol, prescription drugs, or recreational drugs
• Antiretroviral therapy (ART), including treatment for HIV, pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) within the past 3 months
• Regularly taking medication or supplement known to affect appetite, energy expenditure, or weight (e.g. appetite suppressants, steroids-including inhaled steroids but not topical, alpha-blockers, beta-blockers, certain psychotropic medications)

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Drexel University — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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