Active Workplace Study

August 17, 2020 updated by: Brad Wipfli, Oregon Health and Science University
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Usual practice control
Experimental: Total Worker Health Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedentary behavior
Time Frame: Change from baseline at 6 months and 12 months
Sedentary behavior at work measured via accelerometry
Change from baseline at 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height
Time Frame: Baseline, 6-months, and 12-months
Height
Baseline, 6-months, and 12-months
Body weight
Time Frame: Change from baseline at 6 months and 12 months
Directly measured body weight
Change from baseline at 6 months and 12 months
Percent body fat
Time Frame: Change from baseline at 6 months and 12 months
Directly measured percent body fat via bioelectric impedence
Change from baseline at 6 months and 12 months
Blood pressure
Time Frame: Change from baseline at 6 months and 12 months
Direct measurement
Change from baseline at 6 months and 12 months
Resting heart rate
Time Frame: Change from baseline at 6 months and 12 months
Direct measurement
Change from baseline at 6 months and 12 months
Hemoglobin A1c
Time Frame: Change from baseline at 6 months and 12 months
Direct measurement with Siemens DCA Vantage Analyzer
Change from baseline at 6 months and 12 months
Endothelial functioning
Time Frame: Change from baseline at 6 months and 12 months
Direct measurement with EndoPat software and hardware
Change from baseline at 6 months and 12 months
Depression symptoms
Time Frame: Change from baseline at 6 months and 12 months
CES-D Short Form Scale
Change from baseline at 6 months and 12 months
Job Stress
Time Frame: Change from baseline at 6 months and 12 months
Stress in General Scale
Change from baseline at 6 months and 12 months
Work Family Conflict
Time Frame: Change from baseline at 6 months and 12 months
Work Family Conflict Scale
Change from baseline at 6 months and 12 months
General Life Stress
Time Frame: Change from baseline at 6 months and 12 months
Perceived Stress Scale
Change from baseline at 6 months and 12 months
Job satisfaction
Time Frame: Change from baseline at 6 months and 12 months
Michigan Organizational Assessment Questionnaire job satisfaction scale
Change from baseline at 6 months and 12 months
Global Health
Time Frame: Change from baseline at 6 months and 12 months
PROMIS Global Health Scale
Change from baseline at 6 months and 12 months
Support at work
Time Frame: Change from baseline at 6 months and 12 months
Survey measure of perceived support from supervisors at work
Change from baseline at 6 months and 12 months
Dietary behaviors
Time Frame: Change from baseline at 6 months and 12 months
Frequency of high-calorie food and drink consumption
Change from baseline at 6 months and 12 months
Physical Activity survey
Time Frame: Change from baseline at 6 months and 12 months
Healthy Physical Activity Scale
Change from baseline at 6 months and 12 months
Sleep Quality
Time Frame: Change from baseline at 6 months and 12 months
Pittsburgh Sleep Quality Index
Change from baseline at 6 months and 12 months
Sleep Distrubance
Time Frame: Change from baseline at 6 months and 12 months
PROMIS Sleep Disturbance Scale
Change from baseline at 6 months and 12 months
Sleep Impairment
Time Frame: Change from baseline at 6 months and 12 months
PROMIS Sleep Impairment Scale
Change from baseline at 6 months and 12 months
Safety climate
Time Frame: Change from baseline at 6 months and 12 months
Safety Climate Scale
Change from baseline at 6 months and 12 months
Musculoskeletal pain
Time Frame: Change from baseline at 6 months and 12 months
Survey measure of musculoskeletal pain (Nordic Musculoskeletal Symptoms Questionnaire)
Change from baseline at 6 months and 12 months
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
Change from baseline at 6 months and 12 months
Physical activity accelerometer
Time Frame: Change from baseline at 6 months and 12 months
Physical activity measured via accelerometry
Change from baseline at 6 months and 12 months
Occupational Sitting
Time Frame: Change from baseline at 6 months and 12 months
Occupational Sitting and Physical Activity Questionnaire
Change from baseline at 6 months and 12 months
Job Turnover Intentions
Time Frame: Change from baseline at 6 months and 12 months
Job Turnover Intentions Scale
Change from baseline at 6 months and 12 months
Lost Work Time
Time Frame: Change from baseline at 6 months and 12 months
Days missed at work due to illness and injury
Change from baseline at 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Active Workplace Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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