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Physical Activity in the Medical Workplace (OPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794727
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Ivana Croghan, Mayo Clinic

Brief Summary:
Decreased physical activity is not only associated with multiple chronic medical conditions, including obesity, but also with depressed mood, and other negative emotions. As many employed adults spend a great deal of time at work where we are predominantly sedentary, strategies to increase physical activity at work are being pursued to help improve the physical and mental health of Americans. This 17 week randomized controlled trial will investigate changes of occupational physical activity in three groups: those provided with a FitBit® but not able to monitor their activity level, and those provided with activity goals and individual physical activity challenges, and those who do not use a FitBit®.

Condition or disease Intervention/treatment Phase
Physical Activity Device: Blinded Fitbit Device: Unblinded Fitbit Not Applicable

Detailed Description:
All subjects will be entered into a 4 week run-in phase where subjects will wear a blinded Fitbit during work hours. The baseline work activity is collected at this time. This phase is followed by a randomization to one of 3 groups: the blinded Fitbit group, the unblinded Fitbit group, and the group which will not wear any activity monitors. During these 12 weeks we will collect data on activity levels during work hours. Everyone will have a final contact at week 17 to close out the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Activity in the Medical Workplace- a Way to Improve Physical and Mental Well-being?
Study Start Date : June 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Blinded Fitbit
Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.
Device: Blinded Fitbit
Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.

Active Comparator: Unblinded Fitbit
Subjects will wear the physical activity monitor (fitbit) for 12 weeks. They will have access to the monitor display and will have consults with study physician to set goals for the duration of the study.
Device: Unblinded Fitbit
Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.

No Intervention: No Fitbit
Subjects will not wear any activity monitor for 12 weeks.



Primary Outcome Measures :
  1. Change in Fitbit Step Count Per Day [ Time Frame: Baseline through Week 16 ]
    change in number of daily steps as measured by the fitbit monitor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between 18 - 65 years of age
  • Be a Mayo Clinic employee at 0.75 FTE or more
  • Have no previous use of any activity monitor for 14 consecutive days or more
  • Not be pregnant by subject self report
  • Have a stable weight - defined as self-reported weight that has not changed more than 10% in the past 3 months
  • Not have any previous history of joint problems that limit free movement, as determined by the PI
  • Be able to participate fully in all aspects of the study
  • Have understood and signed study informed consent.

Exclusion Criteria:

  • Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence or skew data collection - such as a position where they predominantly provide transport as part of their job.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794727


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Study Chair: Ivana T Croghan, PhD Mayo Cinic
Study Director: Ryan T Hurt, MD, PhD Mayo Clinic
Principal Investigator: Sanjeev Nanda, MD Mayo Clinic
Principal Investigator: Sara Bonnes, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Ivana Croghan, Mayo Clinic:
Additional Information:
Publications of Results:
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Responsible Party: Ivana Croghan, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02794727    
Other Study ID Numbers: 15-003049
First Posted: June 9, 2016    Key Record Dates
Results First Posted: April 29, 2020
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No