Active Workplace Study

• ClinicalTrials.gov Identifier: NCT03556670
• Recruitment Status: Active, not recruiting
• First Posted: June 14, 2018
• Last Update Posted: August 19, 2020
• Sponsor: Oregon Health and Science University
• Collaborator: Portland State University
• Information provided by (Responsible Party): Brad Wipfli, Oregon Health and Science University

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
Sedentary Lifestyle; Occupational Exposure; Health Behavior; Safety Issues	Behavioral: Total Worker Health; Other: Control	Not Applicable

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 (Clinical Trial)
• Estimated 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.
• 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: July 10, 2018
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: December 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 [ Time Frame: Change from baseline at 6 months and 12 months ]
   Sedentary behavior at work measured via accelerometry

Secondary Outcome Measures :

1. Height [ Time Frame: Baseline, 6-months, and 12-months ]
   Height
2. Body weight [ Time Frame: Change from baseline at 6 months and 12 months ]
   Directly measured body weight
3. Percent body fat [ Time Frame: Change from baseline at 6 months and 12 months ]
   Directly measured percent body fat via bioelectric impedence
4. Blood pressure [ Time Frame: Change from baseline at 6 months and 12 months ]
   Direct measurement
5. Resting heart rate [ Time Frame: Change from baseline at 6 months and 12 months ]
   Direct measurement
6. Hemoglobin A1c [ Time Frame: Change from baseline at 6 months and 12 months ]
   Direct measurement with Siemens DCA Vantage Analyzer
7. Endothelial functioning [ Time Frame: Change from baseline at 6 months and 12 months ]
   Direct measurement with EndoPat software and hardware
8. Depression symptoms [ Time Frame: Change from baseline at 6 months and 12 months ]
   CES-D Short Form Scale
9. Job Stress [ Time Frame: Change from baseline at 6 months and 12 months ]
   Stress in General Scale
10. Work Family Conflict [ Time Frame: Change from baseline at 6 months and 12 months ]
    Work Family Conflict Scale
11. General Life Stress [ Time Frame: Change from baseline at 6 months and 12 months ]
    Perceived Stress Scale
12. Job satisfaction [ Time Frame: Change from baseline at 6 months and 12 months ]
    Michigan Organizational Assessment Questionnaire job satisfaction scale
13. Global Health [ Time Frame: Change from baseline at 6 months and 12 months ]
    PROMIS Global Health Scale
14. Support at work [ Time Frame: Change from baseline at 6 months and 12 months ]
    Survey measure of perceived support from supervisors at work
15. Dietary behaviors [ Time Frame: Change from baseline at 6 months and 12 months ]
    Frequency of high-calorie food and drink consumption
16. Physical Activity survey [ Time Frame: Change from baseline at 6 months and 12 months ]
    Healthy Physical Activity Scale
17. Sleep Quality [ Time Frame: Change from baseline at 6 months and 12 months ]
    Pittsburgh Sleep Quality Index
18. Sleep Distrubance [ Time Frame: Change from baseline at 6 months and 12 months ]
    PROMIS Sleep Disturbance Scale
19. Sleep Impairment [ Time Frame: Change from baseline at 6 months and 12 months ]
    PROMIS Sleep Impairment Scale
20. Safety climate [ Time Frame: Change from baseline at 6 months and 12 months ]
    Safety Climate Scale
21. Musculoskeletal pain [ Time Frame: Change from baseline at 6 months and 12 months ]
    Survey measure of musculoskeletal pain (Nordic Musculoskeletal Symptoms Questionnaire)
22. Lost work time [ Time Frame: 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 [ Time Frame: Change from baseline at 6 months and 12 months ]
    Physical activity measured via accelerometry
24. Occupational Sitting [ Time Frame: Change from baseline at 6 months and 12 months ]
    Occupational Sitting and Physical Activity Questionnaire
25. Job Turnover Intentions [ Time Frame: Change from baseline at 6 months and 12 months ]
    Job Turnover Intentions Scale
26. Lost Work Time [ Time Frame: Change from baseline at 6 months and 12 months ]
    Days missed at work due to illness and injury

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 18 years of age or older
• Currently working in a participating organization

Exclusion Criteria:

• None

Contacts and Locations

Locations

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Portland State University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Brad Wipfli, Assistant Professor, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT03556670
• Other Study ID Numbers: Active Workplace Study
• First Posted: June 14, 2018
• Last Update Posted: August 19, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No