Physical Activity in the Medical Workplace

NCT ID: NCT02794727

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-04-30

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Blinded Fitbit

Subjects will wear the physical activity monitor (fitbit) for 12 weeks but will be blinded to the monitor display.

Group Type: SHAM_COMPARATOR

Blinded Fitbit

Intervention Type: DEVICE

Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.

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.

Group Type: ACTIVE_COMPARATOR

Unblinded Fitbit

Intervention Type: DEVICE

Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.

No Fitbit

Subjects will not wear any activity monitor for 12 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Blinded Fitbit

Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.

Intervention Type: DEVICE

Unblinded Fitbit

Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ivana Croghan

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana T Croghan, PhD

Role: STUDY_CHAIR

Mayo Cinic

Ryan T Hurt, MD, PhD

Role: STUDY_DIRECTOR

Mayo Clinic

Sanjeev Nanda, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Sara Bonnes, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31993569 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978599/

pub med link to published study data

Other Identifiers

15-003049

Identifier Type: -

Identifier Source: org_study_id