An interventional study of Total Worker Health and Control in Sedentary Lifestyle, Occupational Exposure and Health Behavior, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-19.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Prevention
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.
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.
Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Total Worker Health
Other: Control
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.
Usual practice control
Sedentary behavior
Sedentary behavior at work measured via accelerometry
Time frame: Change from baseline at 6 months and 12 months
Height
Height
Time frame: Baseline, 6-months, and 12-months
Body weight
Directly measured body weight
Time frame: Change from baseline at 6 months and 12 months
Percent body fat
Directly measured percent body fat via bioelectric impedence
Time frame: Change from baseline at 6 months and 12 months
Blood pressure
Direct measurement
Time frame: Change from baseline at 6 months and 12 months
Resting heart rate
Direct measurement
Time frame: Change from baseline at 6 months and 12 months
Hemoglobin A1c
Direct measurement with Siemens DCA Vantage Analyzer
Time frame: Change from baseline at 6 months and 12 months
Endothelial functioning
Direct measurement with EndoPat software and hardware
Time frame: Change from baseline at 6 months and 12 months
Depression symptoms
CES-D Short Form Scale
Time frame: Change from baseline at 6 months and 12 months
Job Stress
Stress in General Scale
Time frame: Change from baseline at 6 months and 12 months
Work Family Conflict
Work Family Conflict Scale
Time frame: Change from baseline at 6 months and 12 months
General Life Stress
Perceived Stress Scale
Time frame: Change from baseline at 6 months and 12 months
Job satisfaction
Michigan Organizational Assessment Questionnaire job satisfaction scale
Time frame: Change from baseline at 6 months and 12 months
Global Health
PROMIS Global Health Scale
Time frame: Change from baseline at 6 months and 12 months
Support at work
Survey measure of perceived support from supervisors at work
Time frame: Change from baseline at 6 months and 12 months
Dietary behaviors
Frequency of high-calorie food and drink consumption
Time frame: Change from baseline at 6 months and 12 months
Physical Activity survey
Healthy Physical Activity Scale
Time frame: Change from baseline at 6 months and 12 months
Sleep Quality
Pittsburgh Sleep Quality Index
Time frame: Change from baseline at 6 months and 12 months
Sleep Distrubance
PROMIS Sleep Disturbance Scale
Time frame: Change from baseline at 6 months and 12 months
Sleep Impairment
PROMIS Sleep Impairment Scale
Time frame: Change from baseline at 6 months and 12 months
Safety climate
Safety Climate Scale
Time frame: Change from baseline at 6 months and 12 months
Musculoskeletal pain
Survey measure of musculoskeletal pain (Nordic Musculoskeletal Symptoms Questionnaire)
Time frame: 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
Time frame: Change from baseline at 6 months and 12 months
Physical activity accelerometer
Physical activity measured via accelerometry
Time frame: Change from baseline at 6 months and 12 months
Occupational Sitting
Occupational Sitting and Physical Activity Questionnaire
Time frame: Change from baseline at 6 months and 12 months
Job Turnover Intentions
Job Turnover Intentions Scale
Time frame: Change from baseline at 6 months and 12 months
Lost Work Time
Days missed at work due to illness and injury
Time frame: Change from baseline at 6 months and 12 months
Plan to share: 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.
Supporting information: Study protocol, Sap, Analytic code
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Oregon Health and Science University