Sedentary LifestyleNCT03556670
Active Workplace Study
A study testing Total Worker Health in people with Sedentary Lifestyle and Occupational Exposure, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Exposure to sedentary work is an occupational hazard with significant health and safety consequences. Sedentary behavior is an independent predictor of heart disease, diabetes, early mortality, and accounts for the majority of the increase in obesity in the US. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Occupational Exposure, Health Behavior
- What is being tested?
- Total Worker Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to Dec 2020
- 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
- 18 years of age or older
- Currently working in a participating organization
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Exposure to sedentary work is an occupational hazard with significant health and safety consequences. Sedentary behavior is an independent predictor of heart disease, diabetes, early mortality, and accounts for the majority of the increase in obesity in the US. Prolonged sitting, common in modern sedentary work environments, contributes to increases in musculoskeletal pain, injuries, and detrimental changes in physiological functioning. Call center employees, who are among the most sedentary workers in the US, area priority population for Total Worker Health interventions. This project is designed to substantially improve health, safety, and well-being in call center employees, including physiological outcomes that contribute to chronic diseases.The study tests whether a Total Worker Health oriented intervention is more effective than usual practices for increasing the utilization of health and safety resources and improving worker health and safety. Study results will have implications for over 30 million sedentary workers in the US.
Read the detailed description
The purpose of this study is to evaluate how a Total Worker Health intervention targeting sedentary behavior among call center employees improves the health, safety, and well-being of sedentary workers. Our primary hypothesis is that a multilevel integrated intervention that follows the Total Worker Health approach will have a stronger impact on primary outcomes (sedentary time and light physical activity at work, musculoskeletal pain, time lost due to injury or illness) compared to a control condition that matches typical worksite practices. To test our hypothesis, we will 1) tailor Total Worker Health intervention components to the call center environment, 2) determine the effects of a 6-month intervention, and 3) measure the durability of intervention effects at 12-month follow-up.
The study will use a randomized control trial design with two conditions: a control condition and a Total Worker Health intervention condition that includes organizational and individual intervention components. Study participants will include employees and supervisors from up to eight call centers. The call centers will be randomly assigned to the two conditions prior to the start of the study. During the study, we will conduct a baseline assessment; implement a six-month intervention; conduct a post-intervention assessment; and conduct a follow-up assessment at twelve months. During each assessment period, study participants in both conditions will complete a survey, physical measures, hemoglobin A1c measurement, and seven days of physical activity data collection with accelerometers. Study participants in both conditions could additionally be asked to complete a measurement for endothelial function during each assessment.
The baseline assessment will occur directly after participant enrollment and consent at each worksite. Both conditions will be given access to portable pedal stands. The intervention condition will have additional environmental alterations including hanging signs throughout the work environment that promote health and safety behaviors; and replacing high calorie and high sugar food and drink options in vending machines and break rooms with fresh fruits, vegetables, and other healthier choices.
Participants in the intervention condition will begin intervention activities. Intervention activities that participants could be asked to complete include: computer based training, goal setting and behavioral self-monitoring, scripted team-based health and safety discussions, and team competitions with pedal stands. Supervisor participants could additionally be asked to complete additional computer based training, goal setting and behavioral self-monitoring of supportive behaviors, and inter-supervisor observations. Participants in the control condition will receive no additional support beyond the provision of pedal stands.
Repeated measures will be collected at baseline, six months, and 12 months. Our primary hypotheses are that the intervention condition will produce greater reductions in sedentary behavior, increases in light physical activity, and reductions in musculoskeletal pain and sick day use than the control condition. To test these hypotheses, we will employ an intent-to-treat strategy using generalized estimating equations in order to use all available data to evaluate group differences in the magnitude of change over time in primary outcomes. The effect of interest for each outcome will be the interaction of condition X time. We will statistically control for confounders by measuring a wide range of demographic and psychological variables that could impact study outcomes. We will test for baseline differences between conditions on these variables using one-way ANOVAs (continuous variables) or chi-squares tests (categorical variables). Variables that differ significantly between groups at baseline will be included as covariates in the generalized estimating equation models of intervention effects over time.
- Being tested
- Total Worker Health, Control
- Medical subject headings
- Sedentary Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Worker HealthBehavioural
The intervention combines organizational and individual level strategies. Participants will be given access to pedal stands, health and safety messaging, and other environmental modifications. Intervention activities that participants could be asked to complete include: computer based training, goal setting and behavioral self-monitoring, scripted team-based health and safety discussions, and team competitions with pedal stands. Supervisor participants could additionally be asked to complete additional computer based training, goal setting and behavioral self-monitoring of supportive behaviors, and inter-supervisor observations. The intervention is six-months in duration.
ControlOther
Usual practice control
| Study group | Role | What they receive |
|---|---|---|
| Total Worker Health Intervention | Experimental | Not described Receives: Behavioral: Total Worker Health |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary behavior
Sedentary behavior at work measured via accelerometry
Measured: Change from baseline at 6 months and 12 months
Secondary outcomes (26)
Height
Height
Measured: Baseline, 6-months, and 12-months
Body weight
Directly measured body weight
Measured: Change from baseline at 6 months and 12 months
Percent body fat
Directly measured percent body fat via bioelectric impedence
Measured: Change from baseline at 6 months and 12 months
Blood pressure
Direct measurement
Measured: Change from baseline at 6 months and 12 months
Resting heart rate
Direct measurement
Measured: Change from baseline at 6 months and 12 months
Hemoglobin A1c
Direct measurement with Siemens DCA Vantage Analyzer
Measured: Change from baseline at 6 months and 12 months
Endothelial functioning
Direct measurement with EndoPat software and hardware
Measured: Change from baseline at 6 months and 12 months
Depression symptoms
CES-D Short Form Scale
Measured: Change from baseline at 6 months and 12 months
Job Stress
Stress in General Scale
Measured: Change from baseline at 6 months and 12 months
Work Family Conflict
Work Family Conflict Scale
Measured: Change from baseline at 6 months and 12 months
General Life Stress
Perceived Stress Scale
Measured: Change from baseline at 6 months and 12 months
Job satisfaction
Michigan Organizational Assessment Questionnaire job satisfaction scale
Measured: Change from baseline at 6 months and 12 months
Global Health
PROMIS Global Health Scale
Measured: Change from baseline at 6 months and 12 months
Support at work
Survey measure of perceived support from supervisors at work
Measured: Change from baseline at 6 months and 12 months
Dietary behaviors
Frequency of high-calorie food and drink consumption
Measured: Change from baseline at 6 months and 12 months
Physical Activity survey
Healthy Physical Activity Scale
Measured: Change from baseline at 6 months and 12 months
Sleep Quality
Pittsburgh Sleep Quality Index
Measured: Change from baseline at 6 months and 12 months
Sleep Distrubance
PROMIS Sleep Disturbance Scale
Measured: Change from baseline at 6 months and 12 months
Sleep Impairment
PROMIS Sleep Impairment Scale
Measured: Change from baseline at 6 months and 12 months
Safety climate
Safety Climate Scale
Measured: Change from baseline at 6 months and 12 months
Musculoskeletal pain
Survey measure of musculoskeletal pain (Nordic Musculoskeletal Symptoms Questionnaire)
Measured: Change from baseline at 6 months and 12 months
Lost work time
Sick days, tardiness, time lost due to injury and illness, and other work absences
Measured: Change from baseline at 6 months and 12 months
Physical activity accelerometer
Physical activity measured via accelerometry
Measured: Change from baseline at 6 months and 12 months
Occupational Sitting
Occupational Sitting and Physical Activity Questionnaire
Measured: Change from baseline at 6 months and 12 months
Job Turnover Intentions
Job Turnover Intentions Scale
Measured: Change from baseline at 6 months and 12 months
Lost Work Time
Days missed at work due to illness and injury
Measured: Change from baseline at 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start10 Jul 2018
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies 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
- Parallel groups
- Model description
- There are two study conditions: intervention and control. Organizations will be randomized to conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland State University
- Responsible party
- Principal investigator, Brad Wipfli, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556670
- Sponsor's protocol ID
- Active Workplace Study
- Status last verified
- Aug 2020
- First submitted
- 3 May 2018
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will not be routinely provided to other researchers outside of the investigator team. However, requests for specific data from national governmental or international science-based organizations seeking to conduct meta-analyses of such data will be honored. We will make aggregated data from the analyses available to qualified researchers through publications and presentations at scientific meetings. We will make all our quantitative de-identified data available to other scientists after the publication of findings linked to our specific aims outlined in the research plan through the Data Repository or directly if not maintained in the Repository.
Publications
Wipfli B, Wild S, Hanson GC, Shea SA, Winters-Stone K, Thosar SS. The active workplace study: Protocol for a randomized controlled trial with sedentary workers. Contemp Clin Trials. 2021 Apr;103:106311. doi: 10.1016/j.cct.2021.106311. Epub 2021 Feb 2.
PubMed 33539991
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Workplace Study
- ClinicalTrials.gov ID
- NCT03556670
- Acronym / sponsor ID
- Active Workplace Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland State University
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Jun 2018 (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.
Exposure to sedentary work is an occupational hazard with significant health and safety consequences. Sedentary behavior is an independent predictor of heart disease, diabetes, early mortality, and accounts for the majority of the increase in obesity in the US. Prolonged sitting, common in modern sedentary work environments, contributes to increases in musculoskeletal pain, injuries, and detrimental changes in physiological functioning. Call center employees, who are among the most sedentary workers in the US, area priority population for Total Worker Health interventions. This project is designed to substantially improve health, safety, and well-being in call center employees, including physiological outcomes that contribute to chronic diseases.The study tests whether a Total Worker Health oriented intervention is more effective than usual practices for increasing the utilization of health and safety resources and improving worker health and safety. Study results will have implications for over 30 million sedentary workers in the US.
Detailed description
The purpose of this study is to evaluate how a Total Worker Health intervention targeting sedentary behavior among call center employees improves the health, safety, and well-being of sedentary workers. Our primary hypothesis is that a multilevel integrated intervention that follows the Total Worker Health approach will have a stronger impact on primary outcomes (sedentary time and light physical activity at work, musculoskeletal pain, time lost due to injury or illness) compared to a control condition that matches typical worksite practices. To test our hypothesis, we will 1) tailor Total Worker Health intervention components to the call center environment, 2) determine the effects of a 6-month intervention, and 3) measure the durability of intervention effects at 12-month follow-up.
The study will use a randomized control trial design with two conditions: a control condition and a Total Worker Health intervention condition that includes organizational and individual intervention components. Study participants will include employees and supervisors from up to eight call centers. The call centers will be randomly assigned to the two conditions prior to the start of the study. During the study, we will conduct a baseline assessment; implement a six-month intervention; conduct a post-intervention assessment; and conduct a follow-up assessment at twelve months. During each assessment period, study participants in both conditions will complete a survey, physical measures, hemoglobin A1c measurement, and seven days of physical activity data collection with accelerometers. Study participants in both conditions could additionally be asked to complete a measurement for endothelial function during each assessment.
The baseline assessment will occur directly after participant enrollment and consent at each worksite. Both conditions will be given access to portable pedal stands. The intervention condition will have additional environmental alterations including hanging signs throughout the work environment that promote health and safety behaviors; and replacing high calorie and high sugar food and drink options in vending machines and break rooms with fresh fruits, vegetables, and other healthier choices.
Participants in the intervention condition will begin intervention activities. Intervention activities that participants could be asked to complete include: computer based training, goal setting and behavioral self-monitoring, scripted team-based health and safety discussions, and team competitions with pedal stands. Supervisor participants could additionally be asked to complete additional computer based training, goal setting and behavioral self-monitoring of supportive behaviors, and inter-supervisor observations. Participants in the control condition will receive no additional support beyond the provision of pedal stands.
Repeated measures will be collected at baseline, six months, and 12 months. Our primary hypotheses are that the intervention condition will produce greater reductions in sedentary behavior, increases in light physical activity, and reductions in musculoskeletal pain and sick day use than the control condition. To test these hypotheses, we will employ an intent-to-treat strategy using generalized estimating equations in order to use all available data to evaluate group differences in the magnitude of change over time in primary outcomes. The effect of interest for each outcome will be the interaction of condition X time. We will statistically control for confounders by measuring a wide range of demographic and psychological variables that could impact study outcomes. We will test for baseline differences between conditions on these variables using one-way ANOVAs (continuous variables) or chi-squares tests (categorical variables). Variables that differ significantly between groups at baseline will be included as covariates in the generalized estimating equation models of intervention effects over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two study conditions: intervention and control. Organizations will be randomized to conditions.
| Arm | Type | Receives |
|---|---|---|
| Total Worker Health Intervention | Experimental | Behavioral: Total Worker Health |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Currently working in a participating organization
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Total Worker HealthThe intervention combines organizational and individual level strategies. Participants will be given access to pedal stands, health and safety messaging, and other environmental modifications. Intervention activities that participants could be asked to complete include: computer based training, goal setting and behavioral self-monitoring, scripted team-based health and safety discussions, and team competitions with pedal stands. Supervisor participants could additionally be asked to complete additional computer based training, goal setting and behavioral self-monitoring of supportive behaviors, and inter-supervisor observations. The intervention is six-months in duration. | Behavioural | Total Worker Health Intervention |
| ControlUsual practice control | Other | Control |
Primary outcome
Sedentary behavior
Time frame: Change from baseline at 6 months and 12 months
Sedentary behavior at work measured via accelerometry
26 secondary outcomes
Height
Time frame: Baseline, 6-months, and 12-months
Body weight
Time frame: Change from baseline at 6 months and 12 months
Percent body fat
Time frame: Change from baseline at 6 months and 12 months
Blood pressure
Time frame: Change from baseline at 6 months and 12 months
Resting heart rate
Time frame: Change from baseline at 6 months and 12 months
Hemoglobin A1c
Time frame: Change from baseline at 6 months and 12 months
Endothelial functioning
Time frame: Change from baseline at 6 months and 12 months
Depression symptoms
Time frame: Change from baseline at 6 months and 12 months
Job Stress
Time frame: Change from baseline at 6 months and 12 months
Work Family Conflict
Time frame: Change from baseline at 6 months and 12 months
General Life Stress
Time frame: Change from baseline at 6 months and 12 months
Job satisfaction
Time frame: Change from baseline at 6 months and 12 months
Global Health
Time frame: Change from baseline at 6 months and 12 months
Support at work
Time frame: Change from baseline at 6 months and 12 months
Dietary behaviors
Time frame: Change from baseline at 6 months and 12 months
Physical Activity survey
Time frame: Change from baseline at 6 months and 12 months
Sleep Quality
Time frame: Change from baseline at 6 months and 12 months
Sleep Distrubance
Time frame: Change from baseline at 6 months and 12 months
Sleep Impairment
Time frame: Change from baseline at 6 months and 12 months
Safety climate
Time frame: Change from baseline at 6 months and 12 months
Musculoskeletal pain
Time frame: Change from baseline at 6 months and 12 months
Lost work time
Time frame: Change from baseline at 6 months and 12 months
Physical activity accelerometer
Time frame: Change from baseline at 6 months and 12 months
Occupational Sitting
Time frame: Change from baseline at 6 months and 12 months
Job Turnover Intentions
Time frame: Change from baseline at 6 months and 12 months
Lost Work Time
Time frame: Change from baseline at 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 33539991Wipfli B, Wild S, Hanson GC, Shea SA, Winters-Stone K, Thosar SS. The active workplace study: Protocol for a randomized controlled trial with sedentary workers. Contemp Clin Trials. 2021 Apr;103:106311. doi: 10.1016/j.cct.2021.106311. Epub 2021 Feb 2.
- Individual participant dataSharing planned: Yes. Data will not be routinely provided to other researchers outside of the investigator team. However, requests for specific data from national governmental or international science-based organizations seeking to conduct meta-analyses of such data will be honored. We will make aggregated data from the analyses available to qualified researchers through publications and presentations at scientific meetings. We will make all our quantitative de-identified data available to other scientists after the publication of findings linked to our specific aims outlined in the research plan through the Data Repository or directly if not maintained in the Repository.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Worker Health in people with Sedentary Lifestyle and Occupational Exposure, run by Oregon Health and Science 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 2 inclusion and 1 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 19 Aug 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?
Sedentary behavior (time frame: Change from baseline at 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556670, which also lists 1 linked publication.
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 19 Aug 2020; AzTrials last refreshed its copy on 28 Oct 2026.