NCT03556670

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

May 3, 2018

Last Update Submit

August 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sedentary behavior

    Sedentary behavior at work measured via accelerometry

    Change from baseline at 6 months and 12 months

Secondary Outcomes (26)

  • Height

    Baseline, 6-months, and 12-months

  • Body weight

    Change from baseline at 6 months and 12 months

  • Percent body fat

    Change from baseline at 6 months and 12 months

  • Blood pressure

    Change from baseline at 6 months and 12 months

  • Resting heart rate

    Change from baseline at 6 months and 12 months

  • +21 more secondary outcomes

Study Arms (2)

Total Worker Health Intervention

EXPERIMENTAL
Behavioral: Total Worker Health

Control

ACTIVE COMPARATOR
Other: Control

Interventions

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.

Total Worker Health Intervention
ControlOTHER

Usual practice control

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be aware that they're part of a study, but will be masked as to whether their worksite is an intervention or control site.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There are two study conditions: intervention and control. Organizations will be randomized to conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2018

First Posted

June 14, 2018

Study Start

July 10, 2018

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations