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History of Changes for Study: NCT01287208
Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Latest version (submitted December 4, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 28, 2011 None (earliest Version on record)
2 April 30, 2012 Recruitment Status, Study Status and Sponsor/Collaborators
3 October 31, 2012 Study Status, Outcome Measures and Results
4 December 4, 2017 Outcome Measures, Study Status, Arms and Interventions, More Information and Baseline Characteristics
Comparison Format:

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Study NCT01287208
Submitted Date:  January 28, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2010-P-001271
Brief Title: Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Official Title: Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents
Secondary IDs: 1K23HL093221 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: January 2011
Overall Status: Active, not recruiting
Study Start: January 2011
Primary Completion: May 2011 [Anticipated]
Study Completion: May 2011 [Anticipated]
First Submitted: January 28, 2011
First Submitted that
Met QC Criteria:
January 28, 2011
First Posted: February 1, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 28, 2011
Last Update Posted: February 1, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Massachusetts General Hospital
Responsible Party:
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Physical Activity
Keywords: Physical activity
Accelerometer
Steps
Medical residents
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 104 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Unblinded
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 Names:
  • Fitbit
Placebo Comparator: 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.
Device: Activity device
Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject
Other Names:
  • Fitbit
Open or close this module Outcome Measures
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
3. Weight
[ Time Frame: 12 weeks ]

4. Hours of sleep per night
[ Time Frame: 12 weeks ]

Number of hours slept per night as recorded on activity device
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 45 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Massachusetts General Hospital medicine resident

Exclusion Criteria:

  • none
Open or close this module Contacts/Locations
Study Officials: Anne N Thorndike, MD, MPH
Principal Investigator
Massachusetts General Hospital
Locations: United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services