Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
Condition: Obesity
MeSH terms: Obesity
Intervention: Phentermine-Topiramate Extended Release; Placebo; Online support system
Intervention description: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily; Placebo looks exactly like the study drug, but it contains no active ingredient; 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.
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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