RECRUITING

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

Conditions

Obesity Weight loss Weight change trajectory Lifestyle intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Physiology of the Weight Reduced State

Quick Facts

Study Start:2023-09-29

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05748158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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: 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)

Inclusion Criteria

Exclusion 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

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:
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)

Contacts and Locations

Study Contact

Andrew Pelesko, BS

CONTACT

412-383-9584

ajp67@pitt.edu

Principal Investigator

Steven Belle, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Dympna Gallagher, EdD

PRINCIPAL_INVESTIGATOR

Columbia University

Susan Roberts, PhD

PRINCIPAL_INVESTIGATOR

Dartmouth College

Study Locations (Sites)

Columbia University Irving Medical Center

New York, New York, 10032

United States

Drexel University

Philadelphia, Pennsylvania, 19104

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Steven Belle, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
Dympna Gallagher, EdD, PRINCIPAL_INVESTIGATOR, Columbia University
Susan Roberts, PhD, PRINCIPAL_INVESTIGATOR, Dartmouth College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-09-29

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Obesity
Weight loss
Weight change trajectory
Lifestyle intervention

Additional Relevant MeSH Terms

Obesity