HealthyPhase 1NCT06833879
Activity Tracking Study in Healthy Volunteers (MK-0000-419)
A Phase 1 study testing Activity Tracking Watch in people with Healthy, run by Merck Sharp & Dohme LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Activity Tracking Watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2022to 16 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The key inclusion criteria include but are not limited to:
- Is in good health
- Is willing to comply with study restrictions
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altasciences Clinical Kansas, Inc. (Site 0002)
Overland Park, Kansas, 66212
QPS-MRA, LLC (Site 0001)
South Miami, Florida, 33143
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Activity Tracking Watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Tracking WatchDevice
Also called CentrePoint Insight Watch (ActiGraph) and Data Hub
Device includes a wristwatch that tracks physical activity and a data storage unit that transmits data to a central database.
| Study group | Role | What they receive |
|---|---|---|
| Watch Wearing to Track Activity | Experimental | Participants wear a watch that tracks physical activity throughout study. Receives: Device: Activity Tracking Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 2 weeks
Average Daily Overall Activity Count
The average daily overall activity will be reported.
Measured: Up to approximately 2 weeks
Average Daily Total Step Count
The number of average daily total steps will be reported.
Measured: Up to approximately 2 weeks
Average Daily Time (minutes) in Nonsedentary Activity
The average daily time spent in nonsedentary activity will be reported.
Measured: 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.
Measured: Up to approximately 2 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start12 May 2022
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833879
- Sponsor's protocol ID
- 0000-419
- Other IDs
- MK-0000-419
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Use of a Wrist-worn Accelerometer Device for Physical Activity Monitoring in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06833879
- Acronym / sponsor ID
- 0000-419
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Watch Wearing to Track Activity | Experimental | Device: Activity Tracking WatchParticipants wear a watch that tracks physical activity throughout study. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is in good health
- Is willing to comply with study restrictions
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity Tracking WatchAlso: CentrePoint Insight Watch (ActiGraph) and Data HubDevice includes a wristwatch that tracks physical activity and a data storage unit that transmits data to a central database. | Device | Watch Wearing to Track Activity |
Primary outcome
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.
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.
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.
Average Daily Overall Activity Count
Time frame: Up to approximately 2 weeks
The average daily overall activity will be reported.
Average Daily Total Step Count
Time frame: Up to approximately 2 weeks
The number of average daily total steps will be reported.
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.
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.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Activity Tracking Watch in people with Healthy, run by Merck Sharp & Dohme LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants that Wear Watch as Instructed (time frame: Up to approximately 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.