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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01287208
First received: January 28, 2011
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Physical Activity
 Device: Activity monitor
Device: Activity device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Be Fit in Residency: a Randomized Controlled Trial of an Activity Device Among Medicine Residents

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Steps Per Day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Steps will be recorded on the activity device


Secondary Outcome Measures:
  • Distance Per Day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Distance in miles recorded on activity device

  • Calories Burned Per Day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Total calories burned per day recorded on activity device

  • Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Hours of Sleep Per Night [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of hours slept per night as recorded on activity device


Enrollment: 104
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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 Name: 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 Name: Fitbit

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Massachusetts General Hospital medicine resident

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287208

Locations
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
Principal Investigator: Anne N Thorndike, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Anne N. Thorndike, MD, MPH, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01287208     History of Changes
Other Study ID Numbers: 2010-P-001271, 1K23HL093221
Study First Received: January 28, 2011
Results First Received: October 31, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Physical activity
Accelerometer
Steps
Medical residents

ClinicalTrials.gov processed this record on June 18, 2013