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

Phase 4

Completed

• Conditions: Obesity
• Interventions: Drug: Phentermine-Topiramate Extended Release; Drug: Placebo; Other: Online support system

• Registration Number: NCT04408586
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-29
• Study Start: 2020-06-03
• Primary Completion: 2022-06-13
• Study Completion: 2022-10-11
• Results First Submitted: 2023-05-23
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Results First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phentermine - Topiramate Extended Release group	Phentermine-Topiramate Extended Release	-
Phentermine - Topiramate Extended Release group	Online support system	-
Placebo Group	Placebo	-
Placebo Group	Online support system	-

Primary Outcome Measures

Name	Time	Method
Body Weight Change	baseline, 3 months	Change in weight calculated in kilograms.

Secondary Outcome Measures

Name	Time	Method
Change in Calories	baseline, 12 months	The change in calories burned per day
Exercise Sessions	12 months	The number of exercise sessions per week
Tracker Usage	12 months	The amount of time in minutes the tracker was used per week
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 Step Count	baseline,12 months	The change in the number of steps per day
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.
Body Weight Change	baseline, 12 months	Change in weight calculated in kilograms.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States