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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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Physical Activity
Interventions Device: Activity monitor
Device: Activity device
Enrollment 104
Recruitment Details Medical residents were recruited during ambulatory care blocks from July 2010 through November 2010.
Pre-assignment Details Subjects were randomized at the end of December 2010. Four residents withdrew prior to randomization (1 changed mind, 2 said they did not have time, 1 did not complete baseline assessment).
Arm/Group Title Unblinded Blinded
Hide Arm/Group Description Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded. 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.
Period Title: Phase 1: Randomized Phase
Started 52 52
Completed 50 49
Not Completed 2 3
Period Title: Phase 2: Team Competition
Started 50 49
Completed 50 49
Not Completed 0 0
Arm/Group Title Unblinded Blinded Total
Hide Arm/Group Description Activity monitor with visible and on-line feedback Activity monitor with no feedback Total of all reporting groups
Overall Number of Baseline Participants 52 52 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
52
 100.0%
104
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 104 participants
29  (0.3) 29  (0.4) 29  (0.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Female
27
  51.9%
29
  55.8%
56
  53.8%
Male
25
  48.1%
23
  44.2%
48
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 52 participants 104 participants
52 52 104
1.Primary Outcome
Title Steps Per Day
Hide Description Steps will be recorded on the activity device
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
We excluded 4 participants who withdrew prior to randomization and 5 who withdrew after randomization.
Arm/Group Title Unblinded Blinded
Hide Arm/Group Description:
Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
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.
Overall Number of Participants Analyzed 50 49
Median (Inter-Quartile Range)
Unit of Measure: steps per day
6369
(1999 to 8796)
6063
(1299 to 8723)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Blinded
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Distance Per Day
Hide Description Distance in miles recorded on activity device.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not collected because of logistical issues with obtaining this data without using an API.
Arm/Group Title Unblinded Blinded
Hide Arm/Group Description:
Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Calories Burned Per Day
Hide Description Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not collected because of logistical issues with obtaining this data without using an API.
Arm/Group Title Unblinded Blinded
Hide Arm/Group Description:

Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.

Activity monitor: The activity monitor is an accelerometer that records steps, distance, calories, and sleep

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.

Activity device: Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Weight
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Unblinded Blinded
Hide Arm/Group Description:

Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.

Activity monitor: The activity monitor is an accelerometer that records steps, distance, calories, and sleep

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.

Activity device: Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject

Overall Number of Participants Analyzed 50 49
Mean (Standard Deviation)
Unit of Measure: Pounds
155  (28.5) 155  (26.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unblinded, Blinded
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Hours of Sleep Per Night
Hide Description

Number of hours slept per night as recorded on activity device.

This secondary outcome was not measured in the trial.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not collected because of logistical issues with obtaining this data without using an API.
Arm/Group Title Unblinded Blinded
Hide Arm/Group Description:

Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.

Activity monitor: The activity monitor is an accelerometer that records steps, distance, calories, and sleep

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.

Activity device: Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Unblinded Blinded
Hide Arm/Group Description Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded. 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.
All-Cause Mortality
Unblinded Blinded
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Unblinded Blinded
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/52 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Unblinded Blinded
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/52 (0.00%) 

Wearing the device may have increased steps in both groups and decreased ability to see a difference.

Unable to collect some secondary outcomes due to logistical issues with obtaining this data without an applications program interface (API).

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne Thorndike, MD, MPH
Organization: Massachusetts General Hospital
Phone: 617-724-4608
EMail: athorndike@partners.org
Layout table for additonal information
Responsible Party: Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01287208    
Other Study ID Numbers: 2010-P-001271
1K23HL093221 ( U.S. NIH Grant/Contract )
First Submitted: January 28, 2011
First Posted: February 1, 2011
Results First Submitted: October 31, 2012
Results First Posted: November 29, 2012
Last Update Posted: December 7, 2017