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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL093221 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The main objective of this study is to test an intervention to increase the physical activity of medical residents, an employee population with little time for exercise. Specifically, the aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unblinded activity monitor | Active Comparator | Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded. |
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| Blinded activity monitor | Placebo Comparator | Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity monitor | Device | The activity monitor is an accelerometer that records steps, distance, calories, and sleep |
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| Measure | Description | Time Frame |
|---|---|---|
| Steps Per Day | Steps will be recorded on the activity device | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Per Day | Distance in miles recorded on activity device. | 12 weeks |
| Calories Burned Per Day | Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne N Thorndike, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24950218 | Derived | Thorndike AN, Mills S, Sonnenberg L, Palakshappa D, Gao T, Pau CT, Regan S. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial. PLoS One. 2014 Jun 20;9(6):e100251. doi: 10.1371/journal.pone.0100251. eCollection 2014. |
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Subjects were randomized at the end of December 2010. Four residents withdrew prior to randomization (1 changed mind, 2 said they did not have time, 1 did not complete baseline assessment).
Medical residents were recruited during ambulatory care blocks from July 2010 through November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unblinded | Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded. |
| FG001 | Blinded | Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Randomized Phase |
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| Phase 2: Team Competition |
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| ID | Title | Description |
|---|---|---|
| BG000 | Unblinded | Activity monitor with visible and on-line feedback |
| BG001 | Blinded | Activity monitor with no feedback |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Steps Per Day | Steps will be recorded on the activity device | We excluded 4 participants who withdrew prior to randomization and 5 who withdrew after randomization. | Posted | Median | Inter-Quartile Range | steps per day | 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unblinded | Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded. |
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Wearing the device may have increased steps in both groups and decreased ability to see a difference.
Unable to collect some secondary outcomes due to logistical issues with obtaining this data without an applications program interface (API).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Thorndike, MD, MPH | Massachusetts General Hospital | 617-724-4608 | athorndike@partners.org |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| Activity device | Device | Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject |
|
|
| 12 weeks |
| Weight | 6 months |
| Hours of Sleep Per Night | Number of hours slept per night as recorded on activity device. This secondary outcome was not measured in the trial. | 12 weeks |
| NOT COMPLETED |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Distance Per Day | Distance in miles recorded on activity device. | This outcome was not collected because of logistical issues with obtaining this data without using an API. | Posted | 12 weeks |
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| Secondary | Calories Burned Per Day | Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial. | This outcome was not collected because of logistical issues with obtaining this data without using an API. | Posted | 12 weeks |
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| Secondary | Weight | Posted | Mean | Standard Deviation | Pounds | 6 months |
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| Secondary | Hours of Sleep Per Night | Number of hours slept per night as recorded on activity device. This secondary outcome was not measured in the trial. | This outcome was not collected because of logistical issues with obtaining this data without using an API. | Posted | 12 weeks |
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|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Blinded | Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded. | 0 | 52 | 0 | 52 |
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