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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Body Weight Change
Change in weight calculated in kilograms.
Time frame: baseline, 3 months
Body Weight Change
Change in weight calculated in kilograms.
Time frame: baseline, 12 months
Change in Step Count
The change in the number of steps per day
Time frame: baseline,12 months
Change in Calories
The change in calories burned per day
Time frame: baseline, 12 months
Exercise Sessions
The number of exercise sessions per week
Time frame: 12 months
Tracker Usage
The amount of time in minutes the tracker was used per week
Time frame: 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
Time frame: 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.
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Time frame: baseline, 12 months