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Weight Loss Maintenance for Obesity (POWERS Trial)
N/A
Recruiting
Led By Susan Roberts, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how weight loss affects obese adults, with the goal of understanding how to maintain weight loss long-term.
Who is the study for?
Adults aged 25-59 with obesity (BMI: 30-<40 kg/m2) who've been stable in weight for the past 6 months, not pregnant or planning pregnancy within two years, without severe heart conditions, thyroid disease requiring medication, renal disease needing dialysis, liver issues, substance abuse problems, extreme dietary restrictions like veganism or very low carb/fat diets. Participants must have internet access and be able to do ergometry testing.
What is being tested?
The study aims to understand why overweight individuals tend to regain weight after a behavioral weight loss program. It involves an initial evaluation followed by up to a 20-week program aiming for at least a 7% weight reduction from baseline within 37 weeks. Successful participants will then be monitored over one year with clinical exams at four and twelve months post-program.
What are the potential side effects?
This trial does not involve medications; hence there are no direct side effects from interventions like drugs. However, participants may experience general stress related to lifestyle changes required during the behavioral weight loss program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of weight stabilization following at least 7 percent weight loss vs. 52 weeks after weight stabilization following at least 7 percent weight loss
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Side effects data
From 2016 Phase 3 trial • 150 Patients • NCT0085660998%
hunger decrease
60%
Nausea
57%
Headache
40%
Diarrhea
35%
Constipation
33%
Injection site reaction
33%
Gastroesophageal reflux
30%
Itchiness
28%
Vomiting
25%
hypoglycemia
15%
Skin rash
10%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Exenatide
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Weight lossExperimental Treatment1 Intervention
A 37 week behavioral intervention aimed at decreasing energy intake and increasing physical activity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weight loss
2010
Completed Phase 4
~1790
Find a Location
Who is running the clinical trial?
Drexel UniversityOTHER
156 Previous Clinical Trials
48,067 Total Patients Enrolled
31 Trials studying Obesity
6,462 Patients Enrolled for Obesity
Dartmouth CollegeOTHER
86 Previous Clinical Trials
1,419,533 Total Patients Enrolled
1 Trials studying Obesity
55 Patients Enrolled for Obesity
New York State Psychiatric InstituteOTHER
479 Previous Clinical Trials
153,625 Total Patients Enrolled
4 Trials studying Obesity
201 Patients Enrolled for Obesity
University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,781 Total Patients Enrolled
60 Trials studying Obesity
14,114 Patients Enrolled for Obesity
Tufts UniversityOTHER
270 Previous Clinical Trials
594,686 Total Patients Enrolled
20 Trials studying Obesity
105,994 Patients Enrolled for Obesity
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,766,920 Total Patients Enrolled
43 Trials studying Obesity
5,880 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,248 Total Patients Enrolled
472 Trials studying Obesity
590,809 Patients Enrolled for Obesity
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,726,843 Total Patients Enrolled
89 Trials studying Obesity
166,915 Patients Enrolled for Obesity
Susan Roberts, PhDPrincipal InvestigatorDartmouth College
Steven Belle, PhDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
2,667 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis for kidney failure.I take medication for thyroid disease or my TSH levels are not normal.My liver enzymes are very high or I have active gallbladder disease.I have had a lung clot in the last 6 months.I have not had heart disease in the last 6 months.I have been diagnosed with major depression now or within the past 2 years.I am taking medication or supplements that affect my appetite, energy, or weight.My heart condition affects my daily activities.I am between 25 and 59 years old.I have active cancer or am currently on chemotherapy, or I had cancer treatment within the last 5 years, except for non-melanoma skin cancers or cured cancers.I am currently on blood thinner medication.I have diabetes with high blood sugar levels or I am on medication to lower my blood sugar.I have a blood clotting disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Weight loss