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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02794727
Other study ID # 15-003049
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date April 2019

Study information

Verified date April 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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®.


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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date April 2019
Est. primary completion date November 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Blinded Fitbit
Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
Unblinded Fitbit
Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Fitbit Step Count Per Day change in number of daily steps as measured by the fitbit monitor Baseline through Week 16
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