A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program
NCT ID: NCT05748158
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
205 participants
INTERVENTIONAL
2023-09-29
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Physical Activity Choices Everyday
NCT03824769
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
NCT00533052
Psychological Intervention to Reduce Weight Bias Internalization
NCT03572218
Behavioral Strategies for Weight Management
NCT00575731
Adaptive Responses to Overfeeding and Weight
NCT03857048
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Changes, integrated values and patterns in energy intake (EI), energy expenditure (EE), resting energy expenditure (REE) and non-resting energy expenditure (NREE), contribute to the variability in weight change during the 12 months following weight loss.
Assessment time points:
* Baseline (BL): prior to starting the weight loss intervention
* T0: at the end of a period of weight stabilization following at least 7 percent weight loss
* T4: four months (17 weeks) following T0
* T12: twelve months (52 weeks) following T0
Secondary Hypotheses:
Changes, integrated values and patterns in components of EI and EE (listed below) contribute to variability in weight change during the 12 months following weight loss.
EI:
* Psychosocial, food attitude, and food environment assessments
* Diet composition
* Neural activation in food choice/decision-making and cue/taste/reward (functional magnetic resonance imaging \[fMRI\])
* Measures of food choice, delay discounting, and eating in the absence of hunger
* Gastric emptying, appetite-related peptides, and glucose and lipid excursions in response to a meal
EE:
* Physical activity
* 24-hour urine catecholamine
* Muscle contractile efficiency
* Mitochondrial function in biopsied skeletal muscle
* Sleep quality and patterns
* Muscle and adipose tissue gene expression
* Plasma metabolome, proteome, exosomes and exposome
* Stool microbiome
Specific Aims:
Specific Aim 1: Examine total energy expenditure (TEE) and energy intake (EI) at, and between, baseline, the end of the weight stabilization period following at least 7 percent weight loss, 17 weeks and 52 weeks after the end of the weight stabilization period following at least 7 percent weight loss with respect to variability in weight change between the end of the weight stabilization period following at least 7 percent weight loss and 52 weeks after the end of the weight stabilization period following at least 7 percent weight loss.
Specific Aim 2: Examine resting energy expenditure (REE) and non-resting energy expenditure (NREE) at, and between, baseline, the end of the weight stabilization period following at least 7 percent weight loss, 17 weeks and 52 weeks after the end of the weight stabilization period following at least 7 percent weight loss with respect to variability in weight change between the end of the weight stabilization period following at least 7 percent weight loss and 52 weeks after the end of the weight stabilization period following at least 7 percent weight loss.
Specific Aim 3: Assess endophenotypes of EI (e.g. diet composition, food-choice, decision-making, delay discounting, cue/taste reward, gastric emptying, appetite-related peptides, glucose and lipid excursions in response to a meal, sleep patterns, food and social environments) at and between time points at which they are measured (e.g., baseline, the end of the weight stabilization period following at least 7 percent weight loss, 17 weeks and 52 weeks after the end of the weight stabilization period following at least 7 percent weight loss) and examine their contributions to the variability in weight change between the end of the weight stabilization period following at least 7 percent weight loss and 52 weeks later.
Specific Aim 4: Assess endophenotypes of EE (e.g., actigraphy measures, sleep patterns, muscle contractile efficiency, mitochondrial function, muscle and adipose tissue gene expression, plasma metabolome, microbiome, exposome, and environment) at, and between, time points at which they are measured (e.g., baseline, the end of the weight stabilization period following at least 7 percent weight loss, 17 weeks and 52 weeks after the end of the weight stabilization period following at least 7 percent weight loss) and examine their contributions to the variability in weight change between the end of the weight stabilization period following at least 7 percent weight loss and 52 weeks later.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Weight loss
A 37 week behavioral intervention aimed at decreasing energy intake and increasing physical activity.
Weight loss
A behavioral lifestyle program, up to 20 weeks in duration, based on interventions shown to be successful for weight loss such as the Diabetes Prevention Program (DPP), Action for Health in Diabetes (Look AHEAD), and Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Study (CALERIE). Weekly sessions, led by experienced interventionists, will provide education and behavioral strategies for weight loss focused an energy-reduced diet and physical activity.
Participants must meet the following milestones to continue in the study:
* ≥ 2% weight loss anytime between 28 and 34 days after the start of the intervention
* ≥ 5% weight loss anytime between 140 and 146 days after the start of the intervention
* ≥ 7% weight loss by the end of 35 weeks
After achieving ≥7% weight loss followed by weight stability, participants are observed, without further intervention, for 52 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Weight loss
A behavioral lifestyle program, up to 20 weeks in duration, based on interventions shown to be successful for weight loss such as the Diabetes Prevention Program (DPP), Action for Health in Diabetes (Look AHEAD), and Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Study (CALERIE). Weekly sessions, led by experienced interventionists, will provide education and behavioral strategies for weight loss focused an energy-reduced diet and physical activity.
Participants must meet the following milestones to continue in the study:
* ≥ 2% weight loss anytime between 28 and 34 days after the start of the intervention
* ≥ 5% weight loss anytime between 140 and 146 days after the start of the intervention
* ≥ 7% weight loss by the end of 35 weeks
After achieving ≥7% weight loss followed by weight stability, participants are observed, without further intervention, for 52 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
25 Years
59 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Tufts University
OTHER
Columbia University
OTHER
New York State Psychiatric Institute
OTHER
Drexel University
OTHER
University of Pennsylvania
OTHER
Dartmouth College
OTHER
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steven Belle
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Belle, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Dympna Gallagher, EdD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Susan Roberts, PhD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Columbia University Irving Medical Center
New York, New York, United States
Drexel University
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
The Physiology of the Weight Reduced State (POWERS) study website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.