Clinical trial NCT03556670: Active Workplace Study
Official title: Active Workplace Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Lifestyle
Occupational Exposure
Health Behavior
Safety Issues
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland State University
First posted: 2018-06-14
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two study conditions: intervention and control. Organizations will be randomized to conditions.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Sedentary behavior
timeFrame: Change from baseline at 6 months and 12 months
Secondary outcomes:
measure: Height
timeFrame: Baseline, 6-months, and 12-months
measure: Body weight
timeFrame: Change from baseline at 6 months and 12 months
measure: Percent body fat
timeFrame: Change from baseline at 6 months and 12 months
measure: Blood pressure
timeFrame: Change from baseline at 6 months and 12 months
measure: Resting heart rate
timeFrame: Change from baseline at 6 months and 12 months
measure: Hemoglobin A1c
timeFrame: Change from baseline at 6 months and 12 months
measure: Endothelial functioning
timeFrame: Change from baseline at 6 months and 12 months
measure: Depression symptoms
timeFrame: Change from baseline at 6 months and 12 months
measure: Job Stress
timeFrame: Change from baseline at 6 months and 12 months
measure: Work Family Conflict
timeFrame: Change from baseline at 6 months and 12 months
measure: General Life Stress
timeFrame: Change from baseline at 6 months and 12 months
measure: Job satisfaction
timeFrame: Change from baseline at 6 months and 12 months
measure: Global Health
timeFrame: Change from baseline at 6 months and 12 months
measure: Support at work
timeFrame: Change from baseline at 6 months and 12 months
measure: Dietary behaviors
timeFrame: Change from baseline at 6 months and 12 months
measure: Physical Activity survey
timeFrame: Change from baseline at 6 months and 12 months
measure: Sleep Quality
timeFrame: Change from baseline at 6 months and 12 months
measure: Sleep Distrubance
timeFrame: Change from baseline at 6 months and 12 months
measure: Sleep Impairment
timeFrame: Change from baseline at 6 months and 12 months
measure: Safety climate
timeFrame: Change from baseline at 6 months and 12 months
measure: Musculoskeletal pain
timeFrame: Change from baseline at 6 months and 12 months
measure: Lost work time
timeFrame: Change from baseline at 6 months and 12 months
measure: Physical activity accelerometer
timeFrame: Change from baseline at 6 months and 12 months
measure: Occupational Sitting
timeFrame: Change from baseline at 6 months and 12 months
measure: Job Turnover Intentions
timeFrame: Change from baseline at 6 months and 12 months
measure: Lost Work Time
timeFrame: Change from baseline at 6 months and 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: 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.