Sedentary BehaviorNCT04641689
Stand Up Kansas: An Intervention to Reduce Sedentary Behavior in the Home Work Environment
A study testing Desk Only and Program Only in people with Sedentary Behavior and Behavior, Health, run by Kansas State University at 1 site in United States.
Trial summary
This project will examine the effectiveness of an intervention to reduce sedentary behavior in Kansas State University employees who are primarily working from home. We will recruit 100 employees to participate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Behavior, Health, Cholesterolemia
- What is being tested?
- Desk Only and Program Only
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full-time employee (works >30 hours per week)
- Sedentary job (>75% of workday seated)
- Working primarily at home (>80% of typical week)
- Able to safely engage in light intensity physical activity
- No ambulatory limitations
Who cannot join
- Working <30 hours per week
- Standing or physically active >25% of typical workday
- Working on campus >20% of a typical week OR planning to resume work on campus in the next 3 months
- Uncontrolled stage 2 (severe) hypertension without a medical release signed by a physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stand Up Kansas: An Intervention to Reduce Sedentary Behavior in the Workplace
This project will examine the effectiveness of an intervention to reduce sedentary behavior in Kansas State University employees who are primarily working from home. We will recruit 100 employees to participate. Participants will be randomly assigned to one of four conditions: desk only, program only, desk + program, or waitlist control. The program will consist of strategies to reduce sitting and increase physical activity in the home environment. We will assess whether the intervention successfully elicits reductions in sitting among employees, as well as changes in cardiometabolic and work-related outcomes.
Read the detailed description
For this project we will conduct a 12-week intervention that incorporates multiple strategies to reduce sedentary behavior among university employees who are primarily working from home. Participants will be recruited via campus networks.
Participants will attend an initial testing visit, during which anthropometric and health outcome data (blood pressure, blood glucose and cholesterol) will be collected. Following the testing visit, all participants will complete an activity log for the next 5 work days, and a subsample will wear an activPAL 4 device for 7 days. All participants will complete a series of questionnaires (measuring physical activity, fatigue, stress, productivity, mood, and diet) online.
After all baseline data have been collected, participants will be randomized to one of four conditions: desk only, program only, desk + program, or waitlist control. Those in the desk only and desk+program conditions will receive a height-adjustable desk. They will be asked to set up the desk at their home workstation and send a photo of the setup to our research team within one week. Those in the program only and control conditions will receive their height-adjustable desks after completing the post-intervention assessments. Participants assigned to the program only and desk+program conditions will have access to a website that includes a variety of resources for reducing sedentary behavior and increasing physical activity in the home environment. The intervention program will be based on social cognitive theory and will be designed to promote self-efficacy, self-regulation, positive outcome expectations, and social and environmental support. Participants will complete weekly modules that include activities such as goal setting and self-monitoring, action and coping planning, group discussions, etc. The program will also provide suggestions for changes to the home work environment, access to virtual stretching and strengthening videos, examples of technology to prompt breaks, etc. Participants will also receive 2 small group coaching calls via Zoom (at 3 and 8 weeks) to assist them in setting goals for reducing sedentary behavior and overcoming barriers. Participants in the desk only and waitlist control groups will receive access to the program after completing the post-intervention assessments.
All measures will be repeated following the 12-week intervention.
- Conditions
- Sedentary Behavior, Behavior, Health, Cholesterolemia, Obesity, Stress, Hypertension
- Being tested
- Desk Only, Program Only
- Keywords
- physical activity
- Medical subject headings
- Sedentary Behavior, Health Behavior, Obesity, Hypertension, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desk OnlyDevice
Also called VariDesk Pro Plus 36 height-adjustable desk
Provision of height-adjustable desk
Program OnlyBehavioural
Online modules will promote goal setting, self-monitoring, habit formation, social support, barrier identification, and environmental modifications
| Study group | Role | What they receive |
|---|---|---|
| Desk Only | Active comparator | Participants will receive a height-adjustable desk to use in their home work environment. Receives: Device: Desk Only |
| Program Only | Active comparator | Participants will receive 12 weeks of online content to support reductions in sedentary behavior while working from home. Content will be based on social cognitive theory. Receives: Behavioral: Program Only |
| Desk + Program | Experimental | Participants will receive a height-adjustable desk to use in their home work environment AND 12 weeks of online content to support reductions in sedentary behavior while working from home. Receives: Device: Desk Only; Behavioral: Program Only |
| Waitlist Control | No intervention | Participants will receive the intervention (desk + program) after all follow-up data have been collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sedentary behavior during the workday
Measured via 5-day activity log
Measured: Baseline and 12 weeks
Secondary outcomes (13)
Change in physical activity
International Physical Activity Questionnaire (long form)
Measured: Baseline and 12 weeks
Changes in sitting, standing and stepping
activPAL (subsample)
Measured: Baseline and 12 weeks
Change in productivity
Health and Work Questionnaire
Measured: Baseline and 12 weeks
Change in stress
Perceived Stress Scale (4-item)
Measured: Baseline and 12 weeks
Change in fatigue
Fatigue Symptom Inventory
Measured: Baseline and 12 weeks
Change in mood
Positive and Negative Affect Schedule
Measured: Baseline and 12 weeks
Change in diet
Rapid Eating Assessment for Participants - Shortened Version
Measured: Baseline and 12 weeks
Change in blood pressure
Measured using automatic blood pressure cuff
Measured: Baseline and 12 weeks
Change in fasting blood glucose
Blood sample obtained via finger stick
Measured: Baseline and 12 weeks
Change in cholesterol
Total, HDL, and LDL; Blood sample obtained via finger stick
Measured: Baseline and 12 weeks
Change in triglycerides
Blood sample obtained via finger stick
Measured: Baseline and 12 weeks
Change in waist circumference
Measured to the nearest 0.5 cm
Measured: Baseline and 12 weeks
Change in weight
Measured in kg
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start21 Oct 2020
- Primary completionMar 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Principal investigator, Emily Mailey, Kansas State University
- Investigators
- Emily L Mailey, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641689
- Sponsor's protocol ID
- IRB8886
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand Up Kansas: An Intervention to Reduce Sedentary Behavior in the Workplace
- ClinicalTrials.gov ID
- NCT04641689
- Acronym / sponsor ID
- IRB8886
- Conditions
- Sedentary Behavior, Behavior, Health, Cholesterolemia, Obesity, Stress, Hypertension
- Keywords
- physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will examine the effectiveness of an intervention to reduce sedentary behavior in Kansas State University employees who are primarily working from home. We will recruit 100 employees to participate. Participants will be randomly assigned to one of four conditions: desk only, program only, desk + program, or waitlist control. The program will consist of strategies to reduce sitting and increase physical activity in the home environment. We will assess whether the intervention successfully elicits reductions in sitting among employees, as well as changes in cardiometabolic and work-related outcomes.
Detailed description
For this project we will conduct a 12-week intervention that incorporates multiple strategies to reduce sedentary behavior among university employees who are primarily working from home. Participants will be recruited via campus networks.
Participants will attend an initial testing visit, during which anthropometric and health outcome data (blood pressure, blood glucose and cholesterol) will be collected. Following the testing visit, all participants will complete an activity log for the next 5 work days, and a subsample will wear an activPAL 4 device for 7 days. All participants will complete a series of questionnaires (measuring physical activity, fatigue, stress, productivity, mood, and diet) online.
After all baseline data have been collected, participants will be randomized to one of four conditions: desk only, program only, desk + program, or waitlist control. Those in the desk only and desk+program conditions will receive a height-adjustable desk. They will be asked to set up the desk at their home workstation and send a photo of the setup to our research team within one week. Those in the program only and control conditions will receive their height-adjustable desks after completing the post-intervention assessments. Participants assigned to the program only and desk+program conditions will have access to a website that includes a variety of resources for reducing sedentary behavior and increasing physical activity in the home environment. The intervention program will be based on social cognitive theory and will be designed to promote self-efficacy, self-regulation, positive outcome expectations, and social and environmental support. Participants will complete weekly modules that include activities such as goal setting and self-monitoring, action and coping planning, group discussions, etc. The program will also provide suggestions for changes to the home work environment, access to virtual stretching and strengthening videos, examples of technology to prompt breaks, etc. Participants will also receive 2 small group coaching calls via Zoom (at 3 and 8 weeks) to assist them in setting goals for reducing sedentary behavior and overcoming barriers. Participants in the desk only and waitlist control groups will receive access to the program after completing the post-intervention assessments.
All measures will be repeated following the 12-week intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 x 2
| Arm | Type | Receives |
|---|---|---|
| Desk Only | Active comparator | Device: Desk OnlyParticipants will receive a height-adjustable desk to use in their home work environment. |
| Program Only | Active comparator | Behavioral: Program OnlyParticipants will receive 12 weeks of online content to support reductions in sedentary behavior while working from home. Content will be based on social cognitive theory. |
| Desk + Program | Experimental | Device: Desk Only, Behavioral: Program OnlyParticipants will receive a height-adjustable desk to use in their home work environment AND 12 weeks of online content to support reductions in sedentary behavior while working from home. |
| Waitlist Control | No intervention | –Participants will receive the intervention (desk + program) after all follow-up data have been collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Full-time employee (works >30 hours per week)
- Sedentary job (>75% of workday seated)
- Working primarily at home (>80% of typical week)
- Able to safely engage in light intensity physical activity
- No ambulatory limitations
Key exclusion criteria (4 listed)
- Working <30 hours per week
- Standing or physically active >25% of typical workday
- Working on campus >20% of a typical week OR planning to resume work on campus in the next 3 months
- Uncontrolled stage 2 (severe) hypertension without a medical release signed by a physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desk OnlyAlso: VariDesk Pro Plus 36 height-adjustable deskProvision of height-adjustable desk | Device | Desk + Program, Desk Only |
| Program OnlyOnline modules will promote goal setting, self-monitoring, habit formation, social support, barrier identification, and environmental modifications | Behavioural | Desk + Program, Program Only |
Primary outcome
Change in sedentary behavior during the workday
Time frame: Baseline and 12 weeks
Measured via 5-day activity log
13 secondary outcomes
Change in physical activity
Time frame: Baseline and 12 weeks
Changes in sitting, standing and stepping
Time frame: Baseline and 12 weeks
Change in productivity
Time frame: Baseline and 12 weeks
Change in stress
Time frame: Baseline and 12 weeks
Change in fatigue
Time frame: Baseline and 12 weeks
Change in mood
Time frame: Baseline and 12 weeks
Change in diet
Time frame: Baseline and 12 weeks
Change in blood pressure
Time frame: Baseline and 12 weeks
Change in fasting blood glucose
Time frame: Baseline and 12 weeks
Change in cholesterol
Time frame: Baseline and 12 weeks
Change in triglycerides
Time frame: Baseline and 12 weeks
Change in waist circumference
Time frame: Baseline and 12 weeks
Change in weight
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily L Mailey, PhD principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desk Only and Program Only in people with Sedentary Behavior and Behavior, Health, run by Kansas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sedentary behavior during the workday (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.