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

Launched by UNIVERSITY OF PITTSBURGH · Feb 17, 2023

Keywords

ClinConnect Summary

This clinical trial is researching why some people who are overweight regain weight after successfully losing it through a behavior-focused weight loss program. The study aims to understand the physical and biological reasons behind these differences in weight regain among adults aged 25 to 59 who have obesity. Participants will first be evaluated for their eligibility and then take part in a program lasting up to 20 weeks, with the goal of losing at least 7% of their starting weight within 37 weeks. Those who meet this goal will be monitored for one year, with additional check-ups to track their weight and health.

To be eligible for the study, participants must be between 25 and 59 years old, have a body mass index (BMI) between 30 and 40, and have maintained a stable weight for the past six months. They should also be able to take part in certain tests and have access to a smartphone or computer with internet. Throughout the study, participants will receive support and guidance, and will help researchers learn more about weight loss and management, which could benefit many others in the future.

Gender

ALL

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)