Occupational Therapy's Role in Promoting Community Wellness: A Multi-modal Approach to Combat Sedentary Behavior in the Workplace Utilizing Sit-Stand Workstations
Phase: NA
Conditions: Musculoskeletal Pain, Musculoskeletal Strain, Sedentary Lifestyle
Sponsor: West Virginia University

 
 
 
 
 
 
 
 
 
 
 
 
Occupational Therapy’s Role in Promoting Community Wellness Utilizing 
Sit-Stand Workstations 
 
NCT03052426 
 
 
IRB Approval Date: 2/2/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

West Virginia University - Office of Research Integrity and Compliance Protocol Number: 1612397536 
Principal Investigator: Brandy Lynn Brown  
Protocol Questionnaire  
Human Subject Research  
Does the protocol meet the federal definition of research? For help determining the type 
of research you are conducting, see the DHHR Human Subject Regulations Decision 
Charts at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html. 
Yes  
Does the research involve living person(s)?  
Yes  
Will information from individual person(s) be collected as part of this research?  
Yes  
Funding Source  
Is there a secured funding source?  
No  
Locations of Research  
Will the research take place at an off campus location?  
No  
Select the location(s) where the research will be conducted. At least one location must 
be selected.  
WVU Campus  
Will this study require an Inter-Institutional Authorization Agreement (IAA)?  
No  
 
 

Design  
Does the research involve surveys/interviews/questionnaires? If so, attach a copy of the 
interview/survey questions on the Notes & Attachments page. 
Yes  
Will you be asking any questions that are likely to distress your subjects (e.g., questions 
about abuse, trauma, or suicide ideation)? If so, attach counseling services referral list 
on the Notes & Attachments page. 
No  
Please provide a lay summary (written at 6th grade level) that includes a statement 
about the purpose and the general aims of the research. 
The aim of this study is to combat the growing global health issue of sedentary behavior 
and the associated health consequences of prolonged sitting in the workplace. The 
population of desk-based workers makes up a relatively large population and are an 
important target for this health promoting initiative with a focus on improving posture, 
encouraging movement, and fostering a more active and healthy business community. 
It's important to recognize that occupational therapy practitioners can contribute to 
community health promotion/disease prevention programs by the skill-set of 
practitioners to understand habits and routines that influence the adoption and 
maintenance of healthy behaviors.  
Fully describe all procedures to be performed, from start to finish, numbering your 
procedures 1,2,3 or A, B, C (e.g., 1. Recruiting, 2. Consent, 3. Collecting data, 4. How 
findings will be shared, etc.). 
1. Obtain IRB approval 2. Distribute fliers around the HSC building and send an email 
through the wellness office to all faculty and staff in the HSC building. 3. Make an Excel 
file of all interested participants. 4. Contact participants to ensure eligibility. 5. Randomly 
assign participants to one 
of three groups: (1) Sit-Stand station with 4-6 educational sessions and instructions to 
alternate standing and sitting every 90 minutes, (2) Sit-stand station with 4-6 
educational sessions and instructions to stand for 20-30 minutes every hour, (3) Sit-
stand station with 4-6 educational sessions with instructions to alternate sitting and 
standing every hour. *all groups will attend same educational sessions. 5. Schedule 
meeting to review and collect informed consent documents and distribute and collect 
the Stages of Change Questionnaire, the Cornell Musculoskeletal Discomfort 
Questionnaire, and the Movement at Work Questionnaire. 6.Install sit-stand work 
stations in each participants office space. 7. Provide educational sessions on use of sit-
stand workstations and the behavioral monitoring self-report form. 8. Within 2 weeks of 
installation of sit-stand workstation complete observation with each participant to ensure 
safe and efficient use. 9. Collect behavioral  
 

monitoring self-report forms weekly from all participants. 10. Send reminder email or 
text prompts to participants for designated time intervals for the group which they are 
enrolled. 11. After 3 months re-distribute the Stages of Change Questionnaire, Cornell, 
and Movement at Work Questionnaires. 12. After 6 months re-distribute the Stages of 
Change Questionnaire, Cornell, and Movement at Work Questionnaires and collect all 
sit-stand workstations. 13. Clean and analyze data. 14. Write up report and prepare for 
presentation or publication.  
Please describe the investigational procedures that will be performed throughout the 
duration of the study. 
Observation of participants in natural working environment, questionnaires/surveys.  
Please describe the standard of care procedures that will be performed throughout the 
duration of the study. 
All participants will be given the same questionnaires/surveys and behavioral tracking 
forms. All participants will also receive the same education on the use of the sit-stand 
workstation and other helpful office ergonomic tips.  
Will you be assigning or randomizing participants to groups or conditions (e.g., control, 
placebo)?  
Yes  
Describe the group assignment.  
All the groups will receive the same educational sessions and complete the same 
questionnaires. The only difference in groups is in the instructions for alternating sit-
stand time. One group will alternate every 20-30minutes, one every 60 minutes, and 
one every 90 minutes.  
Describe what is known about this topic and why this study is needed. Please include at 
least two reference citations to support your rationale. 
Prolonged sedentary activity and a reduction in human energy expenditure are 
detrimental to many domains of health. In recent years, "populations have become 
increasingly sedentary, with many adults spending a minimum of 70% of their waking 
hours sitting" with little neuromuscular stimulation (Owen, Sparling, Healy, Dunstan and 
Matthews, 2010). Desk-based workers make up a relatively large proportion of this 
population making them an important target for health promotion initiatives focusing on 
solutions to implement healthy workspaces and foster a more active business 
community. Although there is rich literature on the many benefits of reducing sedentary 
behavior, there is a call for further research on the feasibility and long-term effects of sit-
stand desks on achieving this reduction in office settings (Grunseit, et al., 2012). 
Occupational therapy practitioners have the capacity to address this health issue with 
their background in community disease prevention and health promotion to improve an 
individual's wellness and quality of life. More research is also needed to establish the 
specific role of occupational therapy in workplace wellness interventions and apply 

occupation in its natural settings such as the workplace by maximizing performance, 
function, and wellness. By implementing sit-stand work stations with educational 
sessions into offices of desk-based employees long-term, we will better be able to 
analyze how effective this strategy is at decreasing sitting time and measure health and 
behavioral outcomes associated with using this intervention. Grunseit, A. C., Chau, J. 
Y.-Y., van der Ploeg,  
H. P., & Bauman, A. (2013). "Thinking on your feet": A qualitative evaluation of sit-stand 
desks in an Australian workplace. BMC Public Health, 13, 365. Owen, N., Sparling, P. 
B., Healy, G. N.,  
Dunstan, D. W., & Matthews, C. E. (2010). Sedentary Behavior: Emerging Evidence for 
a New Health Risk. Mayo Clinic Proceedings, 85(12), 1138-1141. 
doi:10.4065/mcp.2010.0444  
What method are you going to use to analyze the data?  
Data will be coded and analyzed using a statistical software program. Any qualitative 
data that is collected will be member checked.  
Expedited Review  
Is this study only minimal risk?  
Yes  
Does the research qualify for Expedited Review Category 1 - use of FDA-approved 
medical device? 
No  
Does the research qualify for Expedited Review Category 2 - blood sample collection?  
No  
Does the research qualify for Expedited Review Category 3 - noninvasive collection of 
biological specimens? 
No  
Does the research qualify for Expedited Review Category 4 - noninvasive standard care 
procedures? 
No  
Does the research qualify for Expedited Review Category 5 - evaluation of data (e.g., 
medical records review)?" 
No  

Does the research qualify for Expedited Review Category 6 - voice, video, digital, or 
image recordings? 
No  
Does the research qualify for Expedited Review Category 7 - behavior, surveys, 
interviews, etc.?  
Yes  
Briefly describe how the research meets the requirements of the expedited 
category(ies) selected.  
Participants will be required to complete multiple questionnaires as they participate in 
the intervention. The questionnaires will be assessing changes in behavior, movement 
at work, and discomfort at work.  
Will subjects intentionally be deceived as to the purpose of the study?  
No  
Does the study involve intervention and/or manipulation of the subjects or the subjects' 
environment (e.g., educational intervention or training, experimental or quasi-
experimental design)? 
Yes  
Describe how and where researchers will interact with participants, explaining how 
these interactions will be kept private. 
Researchers will interact with participants on an individual basis in the participants 
private office space. In the event that the participant does not have a private office a 
private space will be reserved at the participants request.  
Describe and assess any potential possibilities for risk or harm to the subjects as a 
result of their participation in the research, including discomforts, hazards, or 
inconveniences to the subjects. The primary inconvenience for the participants will be 
the need for them to clear a space to install the sit-stand work station at their desks. 
Depending on what group the participant is in, they will be asked to track how often they 
stand throughout the day which could be an inconvenience or potential discomfort. The 
sit-stand desk does have mechanical parts that could potentially pinch or injure a 
participant if not used correctly.  
Is the research categorized as interventional medical research? No  
HIPAA  
Does the research involve protected health information (PHI)?  
Yes  

Will the HIPAA and consent forms be combined? If not, attach a separate HIPAA 
Authorization to the Notes & Attachments page. 
Yes  
Are you requesting a HIPAA waiver? If yes, attach a HIPAA Waiver Form on the Notes 
& Attachments page. 
No  
Will the research being conducted at a covered entity require authorization from the 
subject? If yes, attach a HIPAA Form on the Notes & Attachments page - only if a 
combined consent with HIPAA is not used. 
No  
Are you transferring identifiable data to or from another institution? If yes, attach a 
signed and WVU Legal Counsel approved HIPAA Data Use Agreement Form on the 
Notes & Attachments page. 
No  
Will the research being conducted at a covered entity involve data that is de-identified? 
If yes, attach a HIPAA De-Identification Certification Form on the Notes & Attachments 
page. You can find the form here (this is only for NHSR studies). 
No  
Will the study include deceased individuals? If yes, attach a HIPAA Decedents Form on 
the Notes & Attachments page. 
No  
Will data/samples with identifiers be received from another entity? If yes, attach a 
signed, Legal Counsel approved HIPAA Data Use Agreement Form on the Notes & 
Attachments page. 
No  
Subjects  
Will any of the subjects be less than 18 years old?  
No  
Indicate the maximum number of subjects to be enrolled or medical records to be 
reviewed at all sites by the WVU or VAMC research team. 
20  
Provide a rationale for choosing your sample size.  

This study will consist of 3 groups of 6 individuals receiving the sit-stand workstation. 
The workstations are being donated to us to complete the research. And 18-20 
workstations is the max that we can receive.  
State the requirement(s) to become a participant in the study (e.g., age range, sex, 
language spoken, class enrollment/ranking). 
Participants must spend > 50% of their work day seated at the computer. Participants 
can be male or female and must be ages 18 years or older. Participants must be 
primarily English speaking. Participants must work within the Health Sciences Center 
building at West Virginia University.  
Explain why selection of participants will be equitable addressing gender, ethnicity, 
and/or race of subjects. 
Attempts will be made to choose 50% males and 50% females for the study. However, 
given 
the nature of the work it is probable that we will have a higher percentage of females 
than males enrolled. No one will be ineligible based on race or ethnicity.  
In outline format and chronological order, describe what will be done to identify and 
recruit participants (e.g., A, B, C or 1, 2, 3). 
1. Fliers will be distributed throughout the HSC building and an email will be sent from 
the wellness program to all HSC faculty and staff. 2. Interested participants will contact 
a member of the research team who will verify their eligibility to participate. 3. If eligible, 
participants will placed on 
a list in Excel with an email address or phone number to be contacted. 4. Participants 
will then be randomly drawn from the list and contacted to participate in the study. The 
team will draw 9-10 males and 9-10 females to participate. 5. In the event that there are 
20 or fewer participants who are eligible all will be contacted to participate regardless of 
gender.  
Will your study target any of the following vulnerable groups: cognitively impaired, 
pregnant women and fetuses, or prisoners?  
No  
Does this research involve participants who could be coerced or unduly influenced, 
such as current students/employees of research team members? 
No  
Does the protocol deal with cancer prevention, treatment, or diagnosis (including 
surveys)?  
No  

Has this protocol been reviewed by Clinical Trials Working Group (CTWG)? If yes, 
please attach the CTWG's correspondence on the Notes & Attachments page. 
No  
Consent Procedures  
Will SIGNED informed consent be obtained from subjects (all or in part)?  
Yes  
Will the informed consent form be translated into any other language(s)?  
No  
Is a waiver of informed consent being requested (i.e., there will be no consent process 
at all)?  
No  
Describe the consent process (using 1, 2, 3 or A, B, C), addressing when, where, and 
how participants will be informed. 
1. Once a participant is determined to be eligible he/she will be contacted by a member 
of the research team to set up a time to meet in a private space to go over the informed 
consent form. 2. Eligible participants will review the consent form and will be given the 
opportunity to ask any questions. 3. The member of the research team will answer any 
questions or clarify any areas on the form that need to be clarified. 4. Once there aren't 
any more questions and the participant is comfortable with the details of the study, the 
participant and research team member will sign the form. 5. Once the form has been 
signed the participant will place their master code (explained in the confidentiality 
section) on the consent form and remit it to one of the research team members.  
Are you requesting an alteration of consent (e.g., short form, braille consent or 
witnessed verbal consent)? 
No  
Indicate who will be consenting subjects and describe the process of training all 
personnel who will be obtaining consent. 
The PI or any of the Co-I's will be responsible for consenting subjects for the study. All 
of them have completed the required CITI trainings.  
Is a waiver of the requirement to obtain written documentation of the consent process 
being requested (if yes, attach the information to be provided to the participants)? 
No  
Potential Benefits  

Is there any known benefit to the individual subject as a result of participating in the 
research? Payments to subjects should not be included in this section, but addressed in 
the Payments/Reimbursements section. 
Subjects will get to trial a sit-stand workstation free of cost during the timeframe in which 
they participate in the study. Potential benefits that can occur from the use of the sit-
stand work station include but are not limited to: decreased discomfort with work tasks, 
increased productivity, decreased muscle strain, improved circulation, and increased 
energy.  
Describe the potential benefit(s) to society and/or scientific / medical knowledge of the 
planned work. 
Most studies that have examined the use of sit-stand work stations have not looked at 
the dose of sitting versus standing to determine if there is a difference. By examining 
this relationship we may be better able to provide guidelines for the use of this type of 
equipment.  
Confidentiality  
Does this study have a Federal Certificate of Confidentiality? If yes, attach the certificate 
on the Notes & Attachments page. 
No  
At any point during this study, will identifiable data be viewed or recorded?  
Yes  
Data must be kept for a minimum of three (3) years after study completion. In addition to 
the required 3 years, how much longer will the data be kept? 
Data will only be kept for the minimum of 3 years.  
Where will data be securely located?  
The data will be securely located in a locked filing cabinet in the PI's office.  
How will data be destroyed?  
Data will be shredded upon reaching the 3 year timeframe.  
Will anyone other than the PI, research team members, or IRB have access to the 
identifiable data (e.g., sponsor/funding source, other collaborators)? 
No  
Describe the steps that will be taken to maintain the privacy of subjects (e.g., where 
interaction takes place) and the confidentiality of data (e.g., master code). 
Subjects will be provided with directions to create a master code from a member of the 
research team that will be used when they complete and return any questionnaires or 

forms, including the consent form, related to the study. The master code will consist of 
the first two letters of the first name, last two digits of birth year, and first two letters of 
last name. The consent forms containing the master codes will be kept and stored 
separately from the data.  
Financial Considerations  
Will the subject be paid (money, gift certificates, coupons, etc.) to participate in this 
research project? 
No  
Will the subjects incur any costs to participate in this project (e.g., travel, physician fees, 
study procedures, study drugs)? 
No  
Will WVU students receive extra credit for participating in this research project?  
No   
Advertisements  
Will there be advertisements for this study?  
Yes  
Select all the types of advertisement methods that will be utilized. For assistance with 
creating protocol advertisements, utilize the Advertisement Checklist on the ORIC 
website http://oric.research.wvu.edu/r/download/6466. 
Flyer, Recruitment Letter  
Describe where the ad(s) will be placed and attach a copy of the advertisement(s) on 
the Notes & Attachments page. 
The flyer will be posted around the Health Sciences Center building. The recruitment 
letter will be sent through the employee wellness office to staff and faculty at the HSC 
building.  
 
Sample Collection  
Will sample(s) be used?  
No  
Biological Safety  

Does the study involve the handling of any infectious and/or non-infectious agents or 
recombinant DNA? 
No  
Data Protection for IRB  
Does the project have data protection requirements?  
No