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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
Total Worker Health
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

Other trials in United States

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 groups in NCT03556670
Study groupRoleWhat they receive
Total Worker Health InterventionExperimentalNot described
Receives: Behavioral: Total Worker Health
ControlActive comparatorNot described
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sedentary behavior

    Sedentary behavior at work measured via accelerometry

    Measured: Change from baseline at 6 months and 12 months

Secondary outcomes (26)
  1. Height

    Height

    Measured: Baseline, 6-months, and 12-months

  2. Body weight

    Directly measured body weight

    Measured: Change from baseline at 6 months and 12 months

  3. Percent body fat

    Directly measured percent body fat via bioelectric impedence

    Measured: Change from baseline at 6 months and 12 months

  4. Blood pressure

    Direct measurement

    Measured: Change from baseline at 6 months and 12 months

  5. Resting heart rate

    Direct measurement

    Measured: Change from baseline at 6 months and 12 months

  6. Hemoglobin A1c

    Direct measurement with Siemens DCA Vantage Analyzer

    Measured: Change from baseline at 6 months and 12 months

  7. Endothelial functioning

    Direct measurement with EndoPat software and hardware

    Measured: Change from baseline at 6 months and 12 months

  8. Depression symptoms

    CES-D Short Form Scale

    Measured: Change from baseline at 6 months and 12 months

  9. Job Stress

    Stress in General Scale

    Measured: Change from baseline at 6 months and 12 months

  10. Work Family Conflict

    Work Family Conflict Scale

    Measured: Change from baseline at 6 months and 12 months

  11. General Life Stress

    Perceived Stress Scale

    Measured: Change from baseline at 6 months and 12 months

  12. Job satisfaction

    Michigan Organizational Assessment Questionnaire job satisfaction scale

    Measured: Change from baseline at 6 months and 12 months

  13. Global Health

    PROMIS Global Health Scale

    Measured: Change from baseline at 6 months and 12 months

  14. Support at work

    Survey measure of perceived support from supervisors at work

    Measured: Change from baseline at 6 months and 12 months

  15. Dietary behaviors

    Frequency of high-calorie food and drink consumption

    Measured: Change from baseline at 6 months and 12 months

  16. Physical Activity survey

    Healthy Physical Activity Scale

    Measured: Change from baseline at 6 months and 12 months

  17. Sleep Quality

    Pittsburgh Sleep Quality Index

    Measured: Change from baseline at 6 months and 12 months

  18. Sleep Distrubance

    PROMIS Sleep Disturbance Scale

    Measured: Change from baseline at 6 months and 12 months

  19. Sleep Impairment

    PROMIS Sleep Impairment Scale

    Measured: Change from baseline at 6 months and 12 months

  20. Safety climate

    Safety Climate Scale

    Measured: Change from baseline at 6 months and 12 months

  21. Musculoskeletal pain

    Survey measure of musculoskeletal pain (Nordic Musculoskeletal Symptoms Questionnaire)

    Measured: Change from baseline at 6 months and 12 months

  22. 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

  23. Physical activity accelerometer

    Physical activity measured via accelerometry

    Measured: Change from baseline at 6 months and 12 months

  24. Occupational Sitting

    Occupational Sitting and Physical Activity Questionnaire

    Measured: Change from baseline at 6 months and 12 months

  25. Job Turnover Intentions

    Job Turnover Intentions Scale

    Measured: Change from baseline at 6 months and 12 months

  26. 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.

  1. First posted14 Jun 2018
  2. Study start10 Jul 2018
  3. Primary completionSep 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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)
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

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.

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