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

October 30, 2017 updated by: Peggy Hannon, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington Health Promotion Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 45447-EJ
  • 1R01CA160217 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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