Obesity
Conditions
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.
Interventions
DRUGPhentermine-Topiramate Extended Release
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
DRUGPlacebo
Placebo looks exactly like the study drug, but it contains no active ingredient
OTHEROnline 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Change | baseline, 3 months | Change in weight calculated in kilograms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Step Count | baseline,12 months | The change in the number of steps per day |
| Change in Calories | baseline, 12 months | The change in calories burned per day |
| Exercise Sessions | 12 months | The number of exercise sessions per week |
| Body Weight Change | baseline, 12 months | Change in weight calculated in kilograms. |
| Change in SF-12 Physical Score (Health-related Quality Quality of Life) | baseline, 12 months | 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 |
| Change in SF-12 Mental Score (Health-related Quality Quality of Life) | baseline, 12 months | 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. |
| Tracker Usage | 12 months | The amount of time in minutes the tracker was used per week |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phentermine - Topiramate Extended Release Group Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. | 42 |
| Placebo Group Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient
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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. | 38 |
| Total | 80 |
Baseline characteristics
| Characteristic | Phentermine - Topiramate Extended Release Group | Total | Placebo Group |
|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 10.9 | 42 years STANDARD_DEVIATION 10.4 | 40.8 years STANDARD_DEVIATION 10.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 79 Participants | 37 Participants |
| Region of Enrollment United States | 42 participants | 80 participants | 38 participants |
| Sex: Female, Male Female | 36 Participants | 68 Participants | 32 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 38 |
| other Total, other adverse events | 11 / 42 | 3 / 38 |
| serious Total, serious adverse events | 0 / 42 | 0 / 38 |
Outcome results
Primary
Body Weight Change
Change in weight calculated in kilograms.
Time frame: baseline, 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine - Topiramate Extended Release Group | Body Weight Change | -10.80 kilograms |
| Placebo Group | Body Weight Change | -4.04 kilograms |
Secondary
Body Weight Change
Change in weight calculated in kilograms.
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine - Topiramate Extended Release Group | Body Weight Change | -15.32 kilograms |
| Placebo Group | Body Weight Change | -5.85 kilograms |
Secondary
Change in Calories
The change in calories burned per day
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine - Topiramate Extended Release Group | Change in Calories | -193 kcal per day |
| Placebo Group | Change in Calories | 60 kcal per day |
Secondary
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.
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine - Topiramate Extended Release Group | Change in SF-12 Mental Score (Health-related Quality Quality of Life) | 0.42 score on a scale |
| Placebo Group | Change in SF-12 Mental Score (Health-related Quality Quality of Life) | -1.48 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine - Topiramate Extended Release Group | Change in SF-12 Physical Score (Health-related Quality Quality of Life) | 1.99 score on a scale |
| Placebo Group | Change in SF-12 Physical Score (Health-related Quality Quality of Life) | 0.57 score on a scale |
Secondary
Change in Step Count
The change in the number of steps per day
Time frame: baseline,12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phentermine - Topiramate Extended Release Group | Change in Step Count | 1214 steps per day |
| Placebo Group | Change in Step Count | 2316 steps per day |
Secondary
Exercise Sessions
The number of exercise sessions per week
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phentermine - Topiramate Extended Release Group | Exercise Sessions | 2.3 sessions per week | Standard Deviation 1 |
| Placebo Group | Exercise Sessions | 2.1 sessions per week | Standard Deviation 1 |
Secondary
Tracker Usage
The amount of time in minutes the tracker was used per week
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phentermine - Topiramate Extended Release Group | Tracker Usage | 90 minutes/week | Standard Deviation 15 |
| Placebo Group | Tracker Usage | 94 minutes/week | Standard Deviation 12 |