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Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01287208
Recruitment Status : Completed
First Posted : February 1, 2011
Results First Posted : November 29, 2012
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Anne N. Thorndike, MD, MPH, Massachusetts General Hospital

Study Description
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Brief Summary:

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:

  1. To determine if providing medical residents with an activity device that measures steps, distance, and calories burned and tracks this information over time on a website increases residents' physical activity levels as measured by number of steps per day compared to a control group using a blinded activity device (no feedback).
  2. To determine if an unblinded team competition using the activity device directly following the randomized phase increases residents' activity level compared to baseline.
  3. To determine if activity level is associated with change in weight during the residency year.
  4. To determine if the average hours of sleep per week is associated with changes in weight and with activity level.

Condition or disease Intervention/treatment Phase
Physical Activity Device: Activity monitor Device: Activity device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Actual Study Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Unblinded activity monitor
Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
 Device: Activity monitor
The activity monitor is an accelerometer that records steps, distance, calories, and sleep
Other Name: Fitbit
Placebo Comparator: Blinded activity monitor
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.
 Device: Activity device
Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject
Other Name: Fitbit


Outcome Measures
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Primary Outcome Measures :
  1. Steps Per Day [ Time Frame: 12 weeks ]
    Steps will be recorded on the activity device


Secondary Outcome Measures :
  1. Distance Per Day [ Time Frame: 12 weeks ]
    Distance in miles recorded on activity device.

  2. Calories Burned Per Day [ Time Frame: 12 weeks ]
    Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial.

  3. Weight [ Time Frame: 6 months ]
  4. Hours of Sleep Per Night [ Time Frame: 12 weeks ]

    Number of hours slept per night as recorded on activity device.

    This secondary outcome was not measured in the trial.



Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Massachusetts General Hospital medicine resident

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287208


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Anne N Thorndike, MD, MPH Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anne N. Thorndike, MD, MPH, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01287208    
Other Study ID Numbers: 2010-P-001271
1K23HL093221 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2011    Key Record Dates
Results First Posted: November 29, 2012
Last Update Posted: December 7, 2017
Last Verified: December 2017
Keywords provided by Anne N. Thorndike, MD, MPH, Massachusetts General Hospital:
Physical activity
Accelerometer
Steps
Medical residents