Active Workplace Study

Health Behavior Clinical Trial

Official title:

Active Workplace Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03556670
• Other study ID #: Active Workplace Study
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Currently working in a participating organization

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Health Behavior
• Occupational Exposure
• Safety Issues
• Sedentary Lifestyle

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.

Other:
• Control
Usual practice control

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Portland State University

Country where clinical trial is conducted

United States, 

Outcome

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