ObesityPOWERSNCT05748158
A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program
A study testing Weight loss in people with Obesity, run by University of Pittsburgh at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 59 years
- Conditions the study is for
- Obesity
- What is being tested?
- Weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Sep 2023to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
- Currently taking anticoagulant medication
- Currently enrolled in a supervised weight reduction program
- Prior or planned bariatric surgery, endoscopic therapy, device-based therapy for obesity, liposuction, cryolipolysis, or abdominoplasty
- 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
- Current celiac or diagnosed gluten intolerance or inflammatory bowel disease requiring specialized diet
- Night or rotating shift worker
- Known severe allergy (e.g. anaphylaxis) to nuts or other foods
- Systolic blood pressure (BP) <90 mmHg and/or diastolic BP <60 mmHg on 2 measurements during the clinical screening visit.
- 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.
- Metal implants, piercings that cannot be removed, or metal-based tattoos or hair treatments
- Exceeds limitations to fit dual-energy X-ray absorptiometry (DXA) field of view
- Known allergy to lidocaine or acetaminophen
- Non-compliance with appointments or tasks (food diaries, etc.) during the screening phase
- Blood clotting disorder or INR > ULN or PT > ULN or (a)PTT > ULN
- Tendency to form thick or raised scars
- 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
- At high risk for suicide, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Dympna Gallagher, EdD, dg108@cumc.columbia.edu
Rudolph Leibel, MD, RL232@cumc.columbia.edu
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Michael R Lowe, PhD, ml42@drexel.edu
Michael R Lowe, PhD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Matthew Hayes, PhD, hayesmr@pennmedicine.upenn.edu
Kelly Allison, PhD, kca@pennmedicine.upenn.edu
About this study
Official title: Physiology of the Weight Reduced State
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.
Read the detailed description
Primary Hypothesis:
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
- Obesity
- Being tested
- Weight loss
- Keywords
- Obesity, Weight loss, Weight change trajectory, Lifestyle intervention
- Medical subject headings
- Obesity, Weight Loss, Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss | Other | A 37 week behavioral intervention aimed at decreasing energy intake and increasing physical activity. Receives: Behavioral: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change from end of weight stabilization following at least 7 percent weight loss to 52 weeks after weight stabilization following at least 7 percent weight loss
Percentage of lost weight that is regained
Measured: End of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss
Weight change from end of weight stabilization following at least 7 percent weight loss to 52 weeks after weight stabilization following at least 7 percent weight loss
Weight regained
Measured: End of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start29 Sep 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tufts University, Columbia University, New York State Psychiatric Institute, Drexel University, University of Pennsylvania, Dartmouth College
- Responsible party
- Principal investigator, Steven Belle, University of Pittsburgh
- Investigators
- Steven Belle, PhD, Principal investigator, University of PittsburghDympna Gallagher, EdD, Principal investigator, Columbia UniversitySusan Roberts, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748158
- Sponsor's protocol ID
- STUDY21120046
- Other IDs
- U24DK128125, UH3DK128302, UH3DK128298
- Acronym
- POWERS
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant individual participant data (IPD) will be provided to approved ancillary study investigators. All data will be archived, following the end of the study, at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-supported data repository.