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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02005497
Other study ID # 45447-EJ
Secondary ID 1R01CA160217
Status Completed
Phase N/A
First received December 3, 2013
Last updated October 30, 2017
Start date December 2013
Est. completion date June 30, 2017

Study information

Verified date October 2017
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
HealthLinks


Locations

Country Name City State
United States University of Washington Health Promotion Research Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Hammerback K, Hannon PA, Harris JR, Clegg-Thorp C, Kohn M, Parrish A. Perspectives on Workplace Health Promotion Among Employees in Low-Wage Industries. Am J Health Promot. 2015 Jul-Aug;29(6):384-92. doi: 10.4278/ajhp.130924-QUAL-495. Epub 2014 Aug 27. — View Citation

Hannon PA, Hammerback K, Allen CL, Parrish AT, Chan KG, Kohn MJ, Teague S, Beresford SA, Helfrich CD, Harris JR. HealthLinks randomized controlled trial: Design and baseline results. Contemp Clin Trials. 2016 May;48:1-11. doi: 10.1016/j.cct.2016.02.011. Epub 2016 Mar 2. — View Citation

Hannon PA, Harris JR, Sopher CJ, Kuniyuki A, Ghosh DL, Henderson S, Martin DP, Weaver MR, Williams B, Albano DL, Meischke H, Diehr P, Lichiello P, Hammerback KE, Parks MR, Forehand M. Improving low-wage, midsized employers' health promotion practices: a randomized controlled trial. Am J Prev Med. 2012 Aug;43(2):125-33. doi: 10.1016/j.amepre.2012.04.014. — View Citation

Hannon PA, Helfrich CD, Chan KG, Allen CL, Hammerback K, Kohn MJ, Parrish AT, Weiner BJ, Harris JR. Development and Pilot Test of the Workplace Readiness Questionnaire, a Theory-Based Instrument to Measure Small Workplaces' Readiness to Implement Wellness Programs. Am J Health Promot. 2017 Jan;31(1):67-75. doi: 10.4278/ajhp.141204-QUAN-604. Epub 2016 Nov 17. — View Citation

Laing SS, Hannon PA, Talburt A, Kimpe S, Williams B, Harris JR. Increasing evidence-based workplace health promotion best practices in small and low-wage companies, Mason County, Washington, 2009. Prev Chronic Dis. 2012;9:E83. Epub 2012 Apr 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Worksite implementation of evidence-based health promotion interventions 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 Workers' health behaviors related to cancer screening, nutrition, physical activity, and tobacco use 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
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