Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
Study Details
Study Description
Brief Summary
Researchers are assessing the effects of weight loss medication vs a placebo among participants provided with a wearable activity tracker, digital wellness devices and lifestyle recommendations.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Phentermine - Topiramate Extended Release group
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Drug: Phentermine-Topiramate Extended Release
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
Other Names:
Other: Online support system
VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
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Placebo Comparator: Placebo Group
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Drug: Placebo
Placebo looks exactly like the study drug, but it contains no active ingredient
Other: Online support system
VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
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Outcome Measures
Primary Outcome Measures
- Primary Endpoint [3 months]
Total body weight loss (%) at 3 months
Secondary Outcome Measures
- Secondary Endpoints [12 months]
Total body weight loss at 12 months (%).
- Secondary Endpoints [12 months]
Number of steps (average per week) at 12 months, steps
- Secondary Endpoints [12 months]
Calories tracked: calories per day (average per week) at 12 months, kcal.
- Secondary Endpoints [12 months]
Number of exercise sessions (average per week) at 12 months.
- Secondary Endpoints [12 months]
Hours/week using app/tracker (average per week) at 12 months, hours
- Secondary Endpoints [12 months]
Quality of life SF36 (at 12 months), 0-36 scale
- Secondary Endpoints [12 months]
Improvement in obesity-related comorbidities (yes/no)
Eligibility Criteria
Criteria
Inclusion Criteria
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Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
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Age: 18-75 years.
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Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
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Women of childbearing potential must agree to use a method of effective contraception during study participation.
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Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
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Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
Exclusion Criteria
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History of Abdominal bariatric surgery
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Weight is greater than 450 lbs (204 kg)
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Recent use (within the last three months) of any antiobesity medication
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Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months)
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Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months.
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Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
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Hypersensitivity or contraindication to the study medication.
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Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
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Principal Investigator discretion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Andres Acosta, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-011697