Clinical trial NCT04408586: Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
Official title: Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body Weight Change
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Body Weight Change
timeFrame: baseline, 12 months
measure: Change in Step Count
timeFrame: baseline,12 months
measure: Change in Calories
timeFrame: baseline, 12 months
measure: Exercise Sessions
timeFrame: 12 months
measure: Tracker Usage
timeFrame: 12 months
measure: Change in SF-12 Physical Score (Health-related Quality Quality of Life)
timeFrame: baseline, 12 months
measure: Change in SF-12 Mental Score (Health-related Quality Quality of Life)
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andres Acosta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: