A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program
Physiology of the Weight Reduced State
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 25 Years to 59 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 20 weeks, 2 weeks, 1 year
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at why some adults with obesity regain more weight than others after a weight loss program. It is for adults ages 25–59 who aim to lose at least 7% of their starting weight. Those who reach this goal and keep their weight steady for 2 weeks will have checkups over the next year.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 25–59 years old.
- Have a BMI of 30 to less than 40. BMI is a measure of weight compared with height.
- Have stayed within 5% of your current weight for the past 6 months.
- Be able to do an exercise test.
- Have a smartphone, tablet, or computer with internet access.
Who can't join
- Weight history outside the study's limits: more than 5% below your highest weight since age 25 if you are 25–29; if you are 30 or older, more than 5% below your highest weight in the past 5 years or at least 10% below your highest weight since age 30. Pregnancy weights do not count.
- Pregnant, gave birth less than a year ago, or planning pregnancy within 2 years.
- Regular tobacco or nicotine use in the past year; suspected alcohol or drug misuse; or unwilling to stop cannabis for 3 weeks at each of 4 study visits.
- Major depression now or within the past 2 years, a history of an eating disorder, another severe mental illness, or high risk of suicide.
- Certain health problems, including diabetes, thyroid disease needing medicine, kidney disease needing dialysis, HIV, or a recent blood clot in the lungs, heart attack, or stroke.
- Taking medicines that affect appetite, energy use, or weight; taking blood thinners; or using HIV treatment or prevention medicines within the past 3 months.
- Already in a supervised weight loss program, doing intense sports training, or having past or planned weight loss procedures or certain body-shaping procedures.
- Other exclusions include strict diets, certain food or medicine allergies, night or rotating shifts, certain metal in the body, abnormal screening tests, or trouble completing study tasks or keeping weight steady.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age: 25 - \<60 years 2. BMI: 30 - \<40 kg/m2 at the first screening visit 3. Within 5% of current weight, for the past 6 months at the first screening visit 4. Able to participate in ergometry testing 5. Has a smart phone, tablet or computer with access to the internet Exclusion Criteria: 1. If 25-29 years old, \> 5% deviation from maximum weight (excluding weights while pregnant) since age 25 years 2. 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 3. History of pulmonary embolus in the past 6 months 4. Cardiovascular disease (e.g. myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack) within the past 6 months 5. Current major depressive disorder or history of major depressive disorder within 2 years 6. Any regular tobacco or nicotine use in the past year 7. Currently engaging in intense physical training or training for a sports event including, but not limited to, a marathon or body building 8. Currently pregnant, or less than one-year post-partum or actively planning to become pregnant within the next two years 9. Presently classified as being in New York Heart Association Class II or greater or dysrhythmia 10. Diabetes (type 1 or 2 - HbA1c ≥ 6.5%, fasting glucose ≥ 126 mg/dL) or currently taking a glucose lowering medication 11. Thyroid disease requiring hormones or medication or TSH \< 0.5 or \> 5 mIU/L 12. Renal disease requiring dialysis 13. Known HIV infection 14. ALT or AST greater than 5 times the upper limit of normal or active gall bladder disease 15. Significant anemia (Hgb \< 10 g/dL) or thrombocytopenia (platelet count \< 60,000 /mm3) 16. 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) 17. 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 18. Current or past history of anorexia nervosa or bulimia nervosa 19. Current or past diagnosis of binge eating disorder 20. Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder) 21. Unwillingness to abstain from marijuana/cannabis use for 3 weeks at each of the four assessment time points 22. Known or suspected abuse or misuse of alcohol, prescription drugs, or recreational drugs 23. Antiretroviral therapy (ART), including treatment for HIV, pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) within the past 3 months 24. 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) 25. Currently taking anticoagulant medication 26. Currently enrolled in a supervised weight reduction program 27. Prior or planned bariatric surgery, endoscopic therapy, device-based therapy for obesity, liposuction, cryolipolysis, or abdominoplasty 28. Severely restricted diets: Vegan (no meat, fish, dairy, eggs, or honey), very low carbohydrate (\<15% calorie as carbohydrate), very low fat (\<15% calories as fat), or strictly gluten free 29. Current celiac or diagnosed gluten intolerance or inflammatory bowel disease requiring specialized diet 30. Night or rotating shift worker 31. Known severe allergy (e.g. anaphylaxis) to nuts or other foods 32. Systolic blood pressure (BP) \<90 mmHg and/or diastolic BP \<60 mmHg on 2 measurements during the clinical screening visit. 33. Systolic blood pressure (BP) \>160 mmHg and/or diastolic BP \>100 mmHg on at least 2 measurements during the clinical screening visit or resting heart rate \< 45 beats per minute or \>100 on 2 measurements during the clinical screening visit. 34. Metal implants, piercings that cannot be removed, or metal-based tattoos or hair treatments 35. Exceeds limitations to fit dual-energy X-ray absorptiometry (DXA) field of view 36. Known allergy to lidocaine or acetaminophen 37. Non-compliance with appointments or tasks (food diaries, etc.) during the screening phase 38. Blood clotting disorder or INR \> ULN or PT \> ULN or (a)PTT \> ULN 39. Tendency to form thick or raised scars 40. Inability to achieve weight stability (defined in section 4.2.1) during the 2 weeks prior to initiation of the baseline Doubly Labeled Water (DLW) assessment 41. At high risk for suicide, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Study sites (3)
NY
- Columbia University Irving Medical Center · New York, NY 10032Dympna Gallagher, EdD · Study contact · dg108@cumc.columbia.eduRudolph Leibel, MD · Study contact · RL232@cumc.columbia.eduRudolph Leibel, MD · Principal investigatorDympna Gallagher, EdD · Principal investigatorMore trials in New York
PA
- Drexel University · Philadelphia, PA 19104Michael R Lowe, PhD · Study contact · ml42@drexel.eduMichael R Lowe, PhD · Principal investigatorMore trials in Philadelphia
- University of Pennsylvania · Philadelphia, PA 19104Matthew Hayes, PhD · Study contact · hayesmr@pennmedicine.upenn.eduKelly Allison, PhD · Study contact · kca@pennmedicine.upenn.eduMatthew Hayes, PhD · Principal investigatorKelly Allison, PhD · Principal investigatorMore trials in Philadelphia