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

December 4, 2017 updated by: Anne N. Thorndike, MD, MPH, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Massachusetts General Hospital medicine resident

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Fitbit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steps Per Day
Time Frame: 12 weeks
Steps will be recorded on the activity device
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance Per Day
Time Frame: 12 weeks
Distance in miles recorded on activity device.
12 weeks
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.
12 weeks
Weight
Time Frame: 6 months
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-P-001271
  • 1K23HL093221 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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