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Completed

NCT Number: NCT06833879

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

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.

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Key information

Conditions

Healthy

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity Tracking Watch

Device

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

Primary outcomes

  1. Number of Participants that Wear Watch as Instructed

    Time frame: 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.

  2. Number of Provisioned Watches and Data Storage Devices That Were Returned

    Time frame: Up to approximately 2 weeks

    The number of watches and data storage devices provisioned and returned free from malfunction will be reported.

  3. Number of Watches and Data Storage Devices that Successfully Transmit Data

    Time frame: Up to approximately 2 weeks

    The number of watches and data storage devices that successfully transmit data to central database will be reported.

  4. Average Daily Overall Activity Count

    Time frame: Up to approximately 2 weeks

    The average daily overall activity will be reported.

  5. Average Daily Total Step Count

    Time frame: Up to approximately 2 weeks

    The number of average daily total steps will be reported.

  6. Average Daily Time (minutes) in Nonsedentary Activity

    Time frame: Up to approximately 2 weeks

    The average daily time spent in nonsedentary activity will be reported.

  7. Average Daily Time (minutes) in Moderate-to-Vigorous Physical Activity

    Time frame: Up to approximately 2 weeks

    The average daily time spent in moderate-to-vigorous physical activity will be reported.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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