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

• 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: Massachusetts General Hospital
• 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: January 28, 2011
• First Posted Date: February 1, 2011
• Results First Submitted Date: October 31, 2012
• Results First Posted Date: November 29, 2012
• Last Update Posted Date: December 7, 2017
• Actual Study Start Date: October 2010
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 31, 2012)

Steps Per Day [ Time Frame: 12 weeks ]

Steps will be recorded on the activity device

Original Primary Outcome Measures (submitted: January 28, 2011)

steps per day [ Time Frame: 12 weeks ]

Steps will be recorded on the activity device

Current Secondary Outcome Measures (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 (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: 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Physical Activity

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2011): 104
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Massachusetts General Hospital medicine resident

Exclusion Criteria:

• none

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01287208
• Other Study ID Numbers: 2010-P-001271; 1K23HL093221 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Anne N Thorndike, MD, MPH; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: December 2017