- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03556670
Active Workplace Study
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older
- Currently working in a participating organization
Exclusion Criteria:
- None
Study Plan
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
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Usual practice control
|
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Experimental: Total Worker Health Intervention
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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
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
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
Studies a U.S. FDA-regulated device product
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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