Physical Activity in the Medical Workplace- a Way to Improve Physical and Mental Well-being?
Phase: NA
Conditions: Physical Activity
Sponsor: Mayo Clinic

Mayo Clinic - NCT NCT02794727 
FitBit Study 
S. Nanda and S. Bonnes, MD 
Page 1 of 6 
 
 
Physical Activity in the Medical Workplace: 
A way to improve physical and mental well-
being? 
 
 
 
NCT02794727 
 
 
 
04 April 2019 
 
 

Mayo Clinic - NCT NCT02794727 
FitBit Study 
S. Nanda and S. Bonnes, MD 
Page 2 of 6 
 
 
Title: Physical Activity in the Medical Workplace: A way to improve physical and mental well-being? 
 
Abstract 
Many Americans do not meet the physical activity guidelines and the majority of Americans are overweight or 
obese.  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®. We hypothesize that providing awareness of occupational physical 
activity level as measured by an accelerometer (FitBit®) will increase occupational physical activity.  In addition, we 
hypothesize that as measured by the SF-36® and perceived stress scale questionnaire measures of emotional 
health will also improve.   
Specific Aims/Objectives 
 
1. We hypothesize that utilizing a FitBit® to monitor activity level (i.e. Step count); will lead to increased 
occupational physical activity (OPA).  
 
Background  
Less than a third of American adults reach the CDC physical activity guidelines [2].  Many of our occupations are 
sedentary and lead to decreased time in physical activity [3, 4].  Being sedentary is associated with multiple 
adverse health outcomes, including obesity [5, 6].   In an effort to improve health, many workplaces and schools 
are attempting interventions to help increase occupational physical activity (OPA) [7].   
In addition to general health benefits, participation in regular physical activity has been associated with decreased 
risk of depressive symptoms [8].  A review of school and workplace interventions to increase physical activity found 
that after the intervention there were improvements in self-esteem, self-efficacy, satisfaction and commitment 
while there were decreases in anger, difficulty concentrating, fatigue, stress and feelings of sadness and depression 
[7].  A variety of interventions have been tried in numerous settings, many using self-report or questionnaires of 
physical activity [7, 9].  Interventions utilizing pedometers and providing activity goals have been successful at 
increasing OPA at a multi country university study [9]. Correlations with the improvement in OPA with markers of 
physical and mental well-being were not performed [9].  
Our goal with this study is to further investigate the efficacy of workplace interventions to improve physical activity 
as measured by an accelerometer (FitBit®).  The FitBit® has been previously validated as a reliable step counter 
[10].  Our workplace includes many different occupations and we will investigate if participant knowledge of OPA 
level leads to improved OPA levels.  Further, if there is an increase in OPA, is this associated with weight loss and 
with decreased feelings of sadness and depressive symptoms.   
Project Design/Methods  
 
Study Subjects 

Mayo Clinic - NCT NCT02794727 
FitBit Study 
S. Nanda and S. Bonnes, MD 
Page 3 of 6 
 
All employees within divisions of DOM will be eligible to participate in the present study. This will be a 17 week 
randomized controlled trial with a 4-week run-in phase, a 12 week randomized intervention phase, and a 1 week 
post intervention phase.  
 
Inclusion criteria:  
1. Be between 18 – 65 years of age  
2. Be a Mayo Clinic employee at 0.75 FTE or more  
3. Have not used an activity monitor within 2 weeks of study entry 
4. Agrees not use any other activity monitor during study participation  
5. Not be pregnant by subject self-report  
6. Have a stable weight-defined as self-reported weight that has not changed more than 10% in the 
past 3 months  
7. Not have any previous history of joint problems that limit free movement, as determined by the PI  
8. Be able to participate fully in all aspects of the study  
9. Have understood and signed study informed consent 
 
Exclusion criteria:  
1. 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 Groups 
We propose to recruit, consent and screen 270 subjects through IRB approved contact materials such as e-mail, 
phone call, flyers, and classified advertisements in order to randomize 135 to study. All subjects who respond 
will be pre-screened for inclusion and exclusion criteria via a telephone pre-screen.  Those who meet criteria will 
be invited to a consent visit followed by a study screening visit.  After consent and screening has taken place, 
subjects who meet all study entry criteria will be invited to participate in the study.  
 
When a subject is found to be eligible for the study, they will be asked by the study staff to create a google email 
which will be used by the study to download their weekly fitbit data.  Subjects will not have access to this google 
email password since they need to remain blinded to the fitbit data during the trial, but the email and password 
will be returned to them at the end of the study and they will be shown how to change their password so that it 
can remain confidential.  They will also be informed that they will be able to keep the fitbit assigned to them 
once they complete all 17 weeks of the study.  The google email is used by the study staff to download their 
weekly data in an online account and this is the outcome data needed for the study.    
 
The first 20 subjects enrolled in the study will be asked to participate in an additional validation phase.  For this 
validation phase of the subject will be asked to wear a FitBit® on both wrists and walk on a treadmill, located in 
the DAHLC, while the study coordinator records their steps manually using a clicking device.  The subject will be 
asked to walk for 5 minutes at 0.9 MPH, followed by 5 minutes at 3.0 MPH and 5 minutes at 4.0 MPH.  They will 
then be asked to continue on with the blinded run-in phase. 
 
All eligible subjects will be invited to participate in 4-week run-in phase using the FitBit® while at work and be 
blinded to the FitBit® daily activity recording.  This run-in phase will be used to collect baseline OPA data for 
each subject. During the run-in phase subjects will be provided with a FitBit® but will not be made aware of their 
OPA level. FitBit® accounts will be created and maintained by the study team. The FitBit® itself will have the 
displays covered so that it will not be available for the subject to read during the blinded phase(s).   During this 
time subjects will be asked to wear their FitBit® while working and leave the FitBit® at their desk at the end of 

Mayo Clinic - NCT NCT02794727 
FitBit Study 
S. Nanda and S. Bonnes, MD 
Page 4 of 6 
 
each day.  The FitBit® will be collected by study staff at the end of the subjects’ workweek.  During which time 
the coordinating staff will download the weekly data and recharge the devices.  They will then return the 
devices to the subjects at the beginning of their work week. At the end of the 4-week run-in-phase (baseline) 
they will be randomized into one of the three 12 week intervention arms using a computer-driven random 
number generator created with the help of statistician.  The groups to which they will be randomized will be:  
1. Group 1 (control group)- participants will be blinded to their OPA during the entire study (run-in and 
randomized intervention phases).   
2. Group 2 (intervention group)- This group will be able to access their FitBit® activity data by viewing the 
display, therefore they will be unblinded during the randomized intervention phase (and blinded during the 
run-in phase). Participants will be given a specific OPA target based on the results from the run-in phase. The 
principal investigator or one of the co-investigators will meet with the participants randomized into this 
intervention group.  The investigator will meet with subjects within 1 week of the study visit (baseline and 
week 6). Based on the physical activity tracked during the baseline period, instructions will be provided to 
increase the OPA by 5 % a week as determined by their average OPA at their last study visit.  If at the post 6 
week study visit their OPA remains <5000 steps per day, we will encourage the same 5% per week increase 
in OPA.  Various methods such as taking steps as much possible prior to taking elevators, lunch time walks, 
walking breaks, and walking meeting of non-patient related topics will be suggested. The daily FitBit OPA 
activity will be downloaded weekly by the study staff and a print out of the weekly activity will be placed in 
the subjects study files for use by the investigators during these feedback sessions with the subject.  
3. Group 3 (no FitBit® Group) – No  FitBit® during the 12 week randomized intervention phase.  
 
As in the run-in phase, subjects will be asked to wear their FitBit® while working and leave the FitBit® at their 
desk at the end of each day.  The FitBit® will be collected by study staff at the end of the subjects workweek.  
During which time the coordinating staff will download the weekly data and recharge the devices.  They will 
then return the devices to the subjects at the beginning of their work week. 
 
All subjects will be contacted for a final study visit via the telephone at 1 week post the randomized 
intervention. 
 
At baseline, and 6 weeks after they start the randomization intervention and at the end of the randomization 
phase (12 weeks)  all study participants will be asked to complete the perceived stress scale, the SF 36 scale and 
be measured by the InBody 770®.  In addition, subjects in group 2 will meet with one of the study investigators. 
OPA during the first 6 weeks of intervention period would be reviewed. For participants who have met the goal 
OPA, only feedback to continue the OPA would be provided. For participants who have not met the goal OPA, 
further instructions will be provided to improve the OPA.  
 
  Sample Size  
A sample size of 42 in each group will have 80% power to detect a difference in the mean of 2.5% weight loss 
difference between a Group 1 and Group 2, or Group 1 and Group 3, or Group 2 and Group 3 assuming that the 
common standard deviation is 4.00 using a two group t-test with a 0.050 two sided significance level as shown 
below. Adding a control will not change the sample size required in each group since, there will only be a 
comparison between only two groups at a time.  

Mayo Clinic - NCT NCT02794727 
FitBit Study 
S. Nanda and S. Bonnes, MD 
Page 5 of 6 
 
 
 
From the research studies conducted at Mayo Clinic in the past, there is a 6 – 7% drop out rate in the 
recruitment. To account for this drop-out rate, we propose to include 45 subjects in each arm of the study. We 
acknowledge that achieving a 2.5 % change in body weight might not be clinically feasible.  
We propose to run this study as pilot study to estimate the amount of weight loss, change in body fat 
percentage and improvement in satisfaction level. We propose to run a larger randomized controlled study 
using this as preliminary data.      
 
Data Collection  
All data will be collected by the Study coordinator or by an online RedCap survey emailed to the subject. After 
consent and screening is completed, Perceived stress scale questionnaire and SF-36®, height, weight and InBody 
770® scan will be collected, followed by providing the participant with his/her FitBit® for the run-in-phase. After 
the 4-week run-in-phase is completed, subjects will come in for randomization to one of the groups described 
above.   
 
FitBit® devices will be collected on a weekly basis to download activity levels and charge the devices.  A FitBit® 
account will be created for each study participant by the research coordinator to allow us to track activity level 
while keeping all participants blinded during the run-in-phase and group 1 blinded during the randomized 
intervention phase . FitBit® display will be hidden from the wearer for Group 1.  For Group 2, The online 
program  will allow us to limit the information the FitBit® wearers see so that the FitBit® can be specific to the 
goals set by the investigators.  We will repeat the perceived stress scale questionnaire, SF-36® and InBody 770® 
after 6 weeks in the intervention phase and at week 12 which is the end of the randomized intervention phase.  
 
One week after the completion of the study, we will complete one phone visit with each of the subjects. 
 
Subjects must wear the FitBit® at work for a minimum of 48 days out of the possible 60 days during the  
randomization phase.   
 
Data Handling 
To ensure the confidentially of the subjects participating in the present study; no names, social security 
numbers, hospital or clinic numbers will be included in the biostatistics databases. Names, addresses, telephone 
numbers, and any other information needed for recruitment, study involvement, and tracking will be obtained 
and maintained by the project personnel in a secured server with limited access. In addition, all study data (i.e. 
data collection forms as well as regulatory paperwork) will be maintained on a secure file server or in locked 
research data storage rooms to which only designated project staff will have access. All computer files and 
systems will be password protected and accessible by authorized personnel only. Data entry and transfer will be 
performed by the study staff after IRB approval.  
 
Data Analysis  

Mayo Clinic - NCT NCT02794727 
FitBit Study 
S. Nanda and S. Bonnes, MD 
Page 6 of 6 
 
For our current study, participants need to complete the study with the requested data to be considered 
evaluable for the analysis. We will use a t-test to compare groups (from the eligible participants). A 2-sided p-
value < 0.05 would be considered as statistically significant. If the data are highly skewed or non-normal, we will 
use the Wilcoxon Rank-Sum test to compare groups (nonparametric method).  
 
References 
1. 
McHorney, C.A., J.E. Ware, Jr., and A.E. Raczek, The MOS 36-Item Short-Form Health Survey (SF-36): II. 
Psychometric and clinical tests of validity in measuring physical and mental health constructs. Medical 
care, 1993. 31(3): p. 247-63. 
2. 
CDC. One in five adults meet overall physical activity guidelines. 2013  [cited 2015; Available from: 
http://www.cdc.gov/media/releases/2013/p0502-physical-activity.html. 
3. 
McCrady, S.K. and J.A. Levine, Sedentariness at work: how much do we really sit? Obesity, 2009. 17(11): 
p. 2103-5. 
4. 
Miller, R. and W. Brown, Steps and sitting in a working population. International journal of behavioral 
medicine, 2004. 11(4): p. 219-24. 
5. 
Wilmot, E.G., et al., Sedentary time in adults and the association with diabetes, cardiovascular disease 
and death: systematic review and meta-analysis. Diabetologia, 2012. 55(11): p. 2895-905. 
6. 
Saidj, M., et al., Separate and joint associations of occupational and leisure-time sitting with cardio-
metabolic risk factors in working adults: a cross-sectional study. PloS one, 2013. 8(8): p. e70213. 
7. 
Barr-Anderson, D.J., et al., Integration of short bouts of physical activity into organizational routine a 
systematic review of the literature. American journal of preventive medicine, 2011. 40(1): p. 76-93. 
8. 
Dugan, S.A., et al., Association between Physical Activity and Depressive Symptoms: Midlife Women in 
SWAN. Medicine and science in sports and exercise, 2015. 47(2): p. 335-42. 
9. 
Gilson, N.D., et al., Walk@Work: An automated intervention to increase walking in university employees 
not achieving 10,000 daily steps. Preventive medicine, 2013. 56(5): p. 283-7. 
10. 
Takacs, J., et al., Validation of the Fitbit One activity monitor device during treadmill walking. Journal of 
science and medicine in sport / Sports Medicine Australia, 2014. 17(5): p. 496-500.