Physical Activity in the Medical Workplace (OPA)

Physical Activity in the Medical Workplace- a Way to Improve Physical and Mental Well-being?

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®.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Device: Blinded Fitbit; Device: Unblinded Fitbit

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fitbit Step Count Per Day	change in number of daily steps as measured by the fitbit monitor	Baseline through Week 16

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: 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

Publications and helpful links

General Publications

• Nanda S, Hurt RT, Croghan IT, Mundi MS, Gifford SL, Schroeder DR, Fischer KM, Bonnes SL. Improving Physical Activity and Body Composition in a Medical Workplace Using Brief Goal Setting. Mayo Clin Proc Innov Qual Outcomes. 2019 Oct 16;3(4):495-505. doi: 10.1016/j.mayocpiqo.2019.07.002. eCollection 2019 Dec.

Helpful Links

• pub med link to published study data

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 15-003049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No