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

NCT06833879 | Completed Phase 1

• 2 other identifiers: 0000-419MK-0000-419
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 2 weeks

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to approximately 2 weeks

Study Arms (1)

Watch Wearing to Track Activity

EXPERIMENTAL

Participants wear a watch that tracks physical activity throughout study.

Device: Activity Tracking Watch

Interventions

Activity Tracking Watch DEVICE

Device includes a wristwatch that tracks physical activity and a data storage unit that transmits data to a central database.

Also known as: CentrePoint Insight Watch (ActiGraph) and Data Hub

Watch Wearing to Track Activity

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

QPS-MRA, LLC (Site 0001)

South Miami, Florida, 33143, United States

Location

Altasciences Clinical Kansas, Inc. (Site 0002)

Overland Park, Kansas, 66212, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: May 12, 2022
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)