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Increasing Implementation of Evidence-based Interventions at Low-wage Worksites

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ClinicalTrials.gov Identifier: NCT02005497
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peggy Hannon, University of Washington

Brief Summary:
The proposed project will answer key questions about implementing evidence-based health promotion interventions at small and low-wage worksites. Small, low-wage worksites will be randomized to receive HealthLinks (a free American Cancer Society program to disseminate evidence-based interventions), HealthLinks+ (which will include creating worksite wellness committees as part of the program), or to serve in a delayed control group. This approach will identify successful strategies for implementing evidence-based interventions at low-wage worksites to improve workers' cancer screening, healthy eating, physical activity, and tobacco cessation.

Condition or disease Intervention/treatment Phase
Cancer Health Promotion Other: HealthLinks Not Applicable

Detailed Description:
Cancer and other chronic diseases are leading killers and disablers in the United States, and low-income Americans are at high risk for these diseases. Multiple evidence-based interventions (EBIs) exist to improve chronic disease risk behaviors, such as cancer screening, healthy eating, physical activity, and tobacco cessation, yet EBI reach to community settings is poor. Among community settings for reaching low-income adults, worksites stand out because most low-income adults are employed, but worksite implementation of health-promoting EBIs is low. Half of American workers work in small or low-wage worksites, where implementation of these EBIs and readiness to implement are especially low. Even though decision-makers at these worksites are often motivated to promote worker health, they usually have no dedicated wellness staff and face three major barriers in implementing EBIs: 1) lack of awareness of the potential benefits of EBIs, 2) lack of knowledge to choose EBIs, and 3) lack of financial and personnel resources to implement EBIs. Non-profit organizations and others who would assist these worksites face their own barriers. Organizational readiness to implement EBIs is not well understood, and few validated measures are available, especially for worksites. Without reliable and valid measures of worksite readiness, those who would assist them have difficulty: a) identifying worksites that are ready, and b) helping decision-makers get ready to increase their odds of implementation success. The proposed research will address both sets of barriers and contribute to dissemination and implementation research by testing the efficacy of a worksite EBI dissemination program, HealthLinks, developed in partnership with the American Cancer Society, a non-profit organization operating nationwide. HealthLinks is based on Greenhalgh's diffusion of innovations framework and Rogers' diffusion of innovations theory and addresses small and low-wage worksites' barriers by providing free on-site information and recommendations for EBIs and by providing free on-site programs and temporary staffing to assist implementation. We will test HealthLinks via a 3-arm randomized controlled trial. Worksites will receive either 1) HealthLinks, or 2) an enhanced version of HealthLinks that addresses small worksites' lack of personnel by adding worker wellness committees, or will 3) serve in a delayed control group that receives HealthLinks at study end. We will measure worksites' EBI implementation at baseline, 12 months (at the end of the intervention period), and 24 months (to assess maintenance one year after the intervention ends). This design will test the effectiveness of both HealthLinks and of worker wellness committees. We will also measure the effect of both on workers' health behaviors at baseline, 12 months, and 24 months. Finally, we will develop, pilot-test, and validate a measure of worksite readiness to implement EBIs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increasing Implementation of Evidence-based Interventions at Low-wage Worksites
Study Start Date : December 2013
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Arm Intervention/treatment
Experimental: HealthLinks
Worksites in this arm will receive the standard HealthLinks intervention protocol, which includes on-site consulting, toolkits, and support via telephone and email to implement a worksite wellness program and adopt evidence-based practices.
Other: HealthLinks
Active Comparator: HealthLinks+
Worksites in this arm will receive the standard HealthLinks intervention protocol, which includes on-site consulting, toolkits, and support via telephone and email plus support to form a worker wellness committee to implement a worksite wellness program and adopt evidence-based practices.
Other: HealthLinks
No Intervention: Delayed Control
Worksites in this arm will not receive an intervention during the study. After they have provided their final follow-up data, they will receive the HealthLinks intervention.



Primary Outcome Measures :
  1. Worksite implementation of evidence-based health promotion interventions [ Time Frame: up to 24 months ]
    The intervention being tested promotes a package of evidence-based health promotion interventions. The primary outcome is the proportion of these interventions the worksites are implementing at each time-point assessed.


Secondary Outcome Measures :
  1. Workers' health behaviors related to cancer screening, nutrition, physical activity, and tobacco use [ Time Frame: Measured at baseline, 12 months, and 24 months ]
    Workers at participating worksites will complete brief surveys at each time-point assessed that measure their health behaviors related to breast, cervical, and colon cancer screening, healthy eating, physical activity, and tobacco use/cessation.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (for worksites):

  • 20-200 employees
  • In one of the following industries: accommodation and food services; arts, entertainment, and recreation; educational services, health care and social assistance, other services excluding public administration, retail trade
  • Located in King County, Washington State

Exclusion Criteria:

  • Has a wellness committee
  • Fewer than 20% of workers report to a physical worksite

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005497


Locations
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United States, Washington
University of Washington Health Promotion Research Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Margaret A Hannon, PhD, MPH University of Washington

Publications:
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Responsible Party: Peggy Hannon, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02005497     History of Changes
Other Study ID Numbers: 45447-EJ
1R01CA160217 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peggy Hannon, University of Washington:
Cancer prevention and control
Health promotion
Workplace
Dissemination
Implementation