Physical Activity in the Medical Workplace

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Device: Blinded Fitbit; Device: Unblinded Fitbit

• Registration Number: NCT02794727
• Lead Sponsor: 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®.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-09
• Primary Completion: 2018-11
• Study Completion: 2019-04
• Results First Submitted: 2020-03-17
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Results First Posted: 2020-04-29
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blinded Fitbit	Blinded Fitbit	Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.
Unblinded Fitbit	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.

Primary Outcome Measures

Name	Time	Method
Change in Fitbit Step Count Per Day	Baseline through Week 16	change in number of daily steps as measured by the fitbit monitor

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States