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

A Pilot Study to Evaluate the Use of a Wrist-worn Accelerometer Device for Physical Activity Monitoring in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Activity Tracking Watch

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • South Miami, Florida, United States, 33143
      • QPS-MRA, LLC (Site 0001)
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences Clinical Kansas, Inc. (Site 0002)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Watch Wearing to Track Activity; Participants wear a watch that tracks physical activity throughout study.	Device: Activity Tracking Watch; Device includes a wristwatch that tracks physical activity and a data storage unit that transmits data to a central database.; Other Names: CentrePoint Insight Watch (ActiGraph) and Data Hub

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event (AE)	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.	Up to approximately 2 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE	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.	Up to approximately 2 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0000-419; MK-0000-419 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No