Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker

Study Overview
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Brief Summary
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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.

Official Title
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Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.

Conditions
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Obesity

Intervention / Treatment
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* Drug: Phentermine-Topiramate Extended Release
* Drug: Placebo
* Other: Online support system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases. Age: 18-75 years. Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment. Women of childbearing potential must agree to use a method of effective contraception during study participation. 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. Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures Exclusion Criteria History of Abdominal bariatric surgery Weight is greater than 450 lbs (204 kg) Recent use (within the last three months) of any antiobesity medication Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months) 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. 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. Hypersensitivity or contraindication to the study medication. Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent. Principal Investigator discretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phentermine - Topiramate Extended Release group<br> | Drug: Phentermine-Topiramate Extended Release<br>* Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily<br>* Other names: Qsymia;Other: Online support system<br>* 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.<br>|
| Placebo Comparator: Placebo Group<br> | Drug: Placebo<br>* Placebo looks exactly like the study drug, but it contains no active ingredient<br>Other: Online support system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight Change | Change in weight calculated in kilograms. | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight Change | Change in weight calculated in kilograms. | baseline, 12 months | 
| Change in Step Count | The change in the number of steps per day | baseline,12 months | 
| Change in Calories | The change in calories burned per day | baseline, 12 months | 
| Exercise Sessions | The number of exercise sessions per week | 12 months | 
| Tracker Usage | The amount of time in minutes the tracker was used per week | 12 months | 
| Change in SF-12 Physical Score (Health-related Quality Quality of Life) | Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome | baseline, 12 months | 
| Change in SF-12 Mental Score (Health-related Quality Quality of Life) | Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome. | baseline, 12 months |