CancerNCT02005497
Increasing Implementation of Evidence-based Interventions at Low-wage Worksites
A study testing HealthLinks in people with Cancer and Health Promotion, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Health Promotion
- What is being tested?
- HealthLinks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has a wellness committee
- Fewer than 20% of workers report to a physical worksite
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Health Promotion Research Center
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Conditions
- Cancer, Health Promotion
- Being tested
- HealthLinks
- Keywords
- Cancer prevention and control, Health promotion, Workplace, Dissemination, Implementation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthLinksOther
| Study group | Role | What they receive |
|---|---|---|
| HealthLinks | Experimental | 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. Receives: Other: HealthLinks |
| HealthLinks+ | Active comparator | 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. Receives: Other: HealthLinks |
| Delayed Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Secondary outcomes (1)
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: Measured at baseline, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Peggy Hannon, University of Washington
- Investigators
- Margaret A Hannon, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005497
- Sponsor's protocol ID
- 45447-EJ
- Other IDs
- 1R01CA160217
- Status last verified
- Oct 2017
- First submitted
- 3 Dec 2013
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22813676Laing 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.
PubMed 22480612Hannon 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.
PubMed 26946121Hannon 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.
PubMed 26389975Hammerback 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.
PubMed 25162321Harris JR, Kava CM, Chan KCG, Kohn MJ, Hammerback K, Parrish AT, Helfrich CD, Hannon PA. Pathways to Employee Outcomes in a Workplace Health Promotion Program. Am J Health Promot. 2022 May;36(4):662-672. doi: 10.1177/08901171211066898. Epub 2022 Jan 4.
PubMed 34983199
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Implementation of Evidence-based Interventions at Low-wage Worksites
- ClinicalTrials.gov ID
- NCT02005497
- Acronym / sponsor ID
- 45447-EJ
- Conditions
- Cancer, Health Promotion
- Keywords
- Cancer prevention and control, Health promotion, Workplace, Dissemination, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2013
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HealthLinks | Experimental | Other: HealthLinksWorksites 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. |
| HealthLinks+ | Active comparator | Other: HealthLinksWorksites 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. |
| Delayed Control | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Has a wellness committee
- Fewer than 20% of workers report to a physical worksite
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthLinks | Other | HealthLinks, HealthLinks+ |
Primary outcome
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.
1 secondary outcome
Workers' health behaviors related to cancer screening, nutrition, physical activity, and tobacco use
Time frame: Measured at baseline, 12 months, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Background: PubMed 22813676Hannon 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.
- Background: PubMed 22480612Laing 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.
- Background: PubMed 26946121Hannon 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.
- Background: PubMed 26389975Hannon 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.
- Background: PubMed 25162321Hammerback 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.
- Derived from this study: PubMed 34983199Harris JR, Kava CM, Chan KCG, Kohn MJ, Hammerback K, Parrish AT, Helfrich CD, Hannon PA. Pathways to Employee Outcomes in a Workplace Health Promotion Program. Am J Health Promot. 2022 May;36(4):662-672. doi: 10.1177/08901171211066898. Epub 2022 Jan 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret A Hannon, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthLinks in people with Cancer and Health Promotion, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worksite implementation of evidence-based health promotion interventions (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005497, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.