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Trial record 1 of 1 for:    Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
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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

Tracking Information
First Submitted Date  ICMJE January 28, 2011
First Posted Date  ICMJE February 1, 2011
Results First Submitted Date  ICMJE October 31, 2012
Results First Posted Date  ICMJE November 29, 2012
Last Update Posted Date December 7, 2017
Actual Study Start Date  ICMJE October 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
Steps Per Day [ Time Frame: 12 weeks ]
Steps will be recorded on the activity device
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
steps per day [ Time Frame: 12 weeks ]
Steps will be recorded on the activity device
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Distance Per Day [ Time Frame: 12 weeks ]
    Distance in miles recorded on activity device.
  • 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.
  • Weight [ Time Frame: 6 months ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
  • Distance per day [ Time Frame: 12 weeks ]
    Distance in miles recorded on activity device
  • Calories burned per day [ Time Frame: 12 weeks ]
    Total calories burned per day recorded on activity device
  • Weight [ Time Frame: 12 weeks ]
  • Hours of sleep per night [ Time Frame: 12 weeks ]
    Number of hours slept per night as recorded on activity device
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Official Title  ICMJE Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Physical Activity
Intervention  ICMJE
  • Device: Activity monitor
    The activity monitor is an accelerometer that records steps, distance, calories, and sleep
    Other Name: Fitbit
  • Device: Activity device
    Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject
    Other Name: Fitbit
Study Arms  ICMJE
  • 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.
    Intervention: Device: Activity monitor
  • 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.
    Intervention: Device: Activity device
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2011)
104
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Massachusetts General Hospital medicine resident

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01287208
Other Study ID Numbers  ICMJE 2010-P-001271
1K23HL093221 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
Original Responsible Party Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Anne N Thorndike, MD, MPH Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP