Active Workplace Study

Sponsor
Oregon Health and Science University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03556670
Collaborator
Portland State University (Other)
264
1
2
28.7
9.2

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Total Worker Health
  • Other: Control
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are two study conditions: intervention and control. Organizations will be randomized to conditions.There are two study conditions: intervention and control. Organizations will be randomized to conditions.
Masking:
Single (Participant)
Masking Description:
Participants will be aware that they're part of a study, but will be masked as to whether their worksite is an intervention or control site.
Primary Purpose:
Prevention
Official Title:
Active Workplace Study
Actual Study Start Date :
Jul 10, 2018
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Total Worker Health Intervention

Behavioral: Total Worker Health
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.

Active Comparator: Control

Other: Control
Usual practice control

Outcome Measures

Primary Outcome Measures

  1. Sedentary behavior [Change from baseline at 6 months and 12 months]

    Sedentary behavior at work measured via accelerometry

Secondary Outcome Measures

  1. Height [Baseline, 6-months, and 12-months]

    Height

  2. Body weight [Change from baseline at 6 months and 12 months]

    Directly measured body weight

  3. Percent body fat [Change from baseline at 6 months and 12 months]

    Directly measured percent body fat via bioelectric impedence

  4. Blood pressure [Change from baseline at 6 months and 12 months]

    Direct measurement

  5. Resting heart rate [Change from baseline at 6 months and 12 months]

    Direct measurement

  6. Hemoglobin A1c [Change from baseline at 6 months and 12 months]

    Direct measurement with Siemens DCA Vantage Analyzer

  7. Endothelial functioning [Change from baseline at 6 months and 12 months]

    Direct measurement with EndoPat software and hardware

  8. Depression symptoms [Change from baseline at 6 months and 12 months]

    CES-D Short Form Scale

  9. Job Stress [Change from baseline at 6 months and 12 months]

    Stress in General Scale

  10. Work Family Conflict [Change from baseline at 6 months and 12 months]

    Work Family Conflict Scale

  11. General Life Stress [Change from baseline at 6 months and 12 months]

    Perceived Stress Scale

  12. Job satisfaction [Change from baseline at 6 months and 12 months]

    Michigan Organizational Assessment Questionnaire job satisfaction scale

  13. Global Health [Change from baseline at 6 months and 12 months]

    PROMIS Global Health Scale

  14. Support at work [Change from baseline at 6 months and 12 months]

    Survey measure of perceived support from supervisors at work

  15. Dietary behaviors [Change from baseline at 6 months and 12 months]

    Frequency of high-calorie food and drink consumption

  16. Physical Activity survey [Change from baseline at 6 months and 12 months]

    Healthy Physical Activity Scale

  17. Sleep Quality [Change from baseline at 6 months and 12 months]

    Pittsburgh Sleep Quality Index

  18. Sleep Distrubance [Change from baseline at 6 months and 12 months]

    PROMIS Sleep Disturbance Scale

  19. Sleep Impairment [Change from baseline at 6 months and 12 months]

    PROMIS Sleep Impairment Scale

  20. Safety climate [Change from baseline at 6 months and 12 months]

    Safety Climate Scale

  21. Musculoskeletal pain [Change from baseline at 6 months and 12 months]

    Survey measure of musculoskeletal pain (Nordic Musculoskeletal Symptoms Questionnaire)

  22. Lost work time [Change from baseline at 6 months and 12 months]

    Sick days, tardiness, time lost due to injury and illness, and other work absences

  23. Physical activity accelerometer [Change from baseline at 6 months and 12 months]

    Physical activity measured via accelerometry

  24. Occupational Sitting [Change from baseline at 6 months and 12 months]

    Occupational Sitting and Physical Activity Questionnaire

  25. Job Turnover Intentions [Change from baseline at 6 months and 12 months]

    Job Turnover Intentions Scale

  26. Lost Work Time [Change from baseline at 6 months and 12 months]

    Days missed at work due to illness and injury

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18 years of age or older

  • Currently working in a participating organization

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Health & Science University Portland Oregon United States 97239

Sponsors and Collaborators

  • Oregon Health and Science University
  • Portland State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brad Wipfli, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT03556670
Other Study ID Numbers:
  • Active Workplace Study
First Posted:
Jun 14, 2018
Last Update Posted:
Aug 19, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 19, 2020