Activity Tracking Study in Healthy Volunteers (MK-0000-419)

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT06833879
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

In this study, researchers want to learn if a watch can be used to track physical activity in healthy people. The watch will collect the data and send it to a database using a data storage device.

The goal of this study is to measure:

* The number of people who wear the watch as instructed

* The number of working watches and data storage devices returned at the end of the study

* The number of watches that successfully sent data back to a database

* The overall daily activity for people including the number of daily steps taken and how much time is spent doing non-exercise activity and mild to intense exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-12
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

The key inclusion criteria include but are not limited to:

• Is in good health
• Is willing to comply with study restrictions

Exclusion Criteria

The key exclusion criteria include but are not limited to:

• History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• History of cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants that Wear Watch as Instructed	Up to approximately 2 weeks	The number of participants that wear the watch for at least 19.2 hours per day (80% of the time) will be reported.
Number of Provisioned Watches and Data Storage Devices That Were Returned	Up to approximately 2 weeks	The number of watches and data storage devices provisioned and returned free from malfunction will be reported.
Number of Watches and Data Storage Devices that Successfully Transmit Data	Up to approximately 2 weeks	The number of watches and data storage devices that successfully transmit data to central database will be reported.
Average Daily Overall Activity Count	Up to approximately 2 weeks	The average daily overall activity will be reported.
Average Daily Total Step Count	Up to approximately 2 weeks	The number of average daily total steps will be reported.
Average Daily Time (minutes) in Nonsedentary Activity	Up to approximately 2 weeks	The average daily time spent in nonsedentary activity will be reported.
Average Daily Time (minutes) in Moderate-to-Vigorous Physical Activity	Up to approximately 2 weeks	The average daily time spent in moderate-to-vigorous physical activity will be reported.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 2 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.; The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Intervention Due to an AE	Up to approximately 2 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.; The number of participants who discontinue study intervention due to an AE will be reported.

Trial Locations

Locations (2)

QPS-MRA, LLC (Site 0001); 🇺🇸 South Miami, Florida, United States

Altasciences Clinical Kansas, Inc. (Site 0002); 🇺🇸 Overland Park, Kansas, United States