Healthy
Conditions
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.
Interventions
DEVICEActivity Tracking Watch
Device includes a wristwatch that tracks physical activity and a data storage unit that transmits data to a central database.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed