- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03930420
Training LHDs to Disseminate Evidence-Based Interventions to Small Worksites
Training Local Health Departments to Disseminate Evidence-Based Interventions to Small and Low-Wage Worksites
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cancer and other chronic diseases are the leading causes of death in the United States for working-age adults. There are several behavioral risk factors that increase disease risk, including missed cancer screenings, physical inactivity, poor eating habits, and tobacco use. Evidence-based interventions (EBIs) exist that improve each of these risk behaviors, and many of these EBIs can be implemented in worksites where the majority of U.S. adults spend most of their waking hours. There are significant disparities in access to worksite EBIs; large worksites (more than 1000 employees) are much more likely to offer EBIs to their employees than small worksites with less than 250 employees. The American Cancer Society (ACS) and the University of Washington Health Promotion Research Center (HPRC) developed Connect to Wellness, a package of EBIs appropriate and feasible for small worksites. A recent randomized controlled trial of Connect to Wellness with 69 small worksites showed that worksites in the Connect to Wellness arms implemented significantly more EBIs at follow-up than worksites in the delayed control arm.
The objective of the present study is to test different methods of scaling up Connect to Wellness. Local health departments (LHDs) cover almost every community in the United States and most LHDs' missions include preventing chronic disease. In a separate project, UW pilot-tested training staff in six LHDs in Washington State to deliver Connect to Wellness to worksites in their communities. LHD staff completed the training and recruited worksites to participate in Connect to Wellness; these worksites implemented EBIs. The primary goals of this competing renewal are (a) to scale up Connect to Wellness by training staff in LHDs across the United States to deliver Connect to Wellness to small employers in their communities, and (b) to further implementation science by conducting a hybrid type III trial comparing the effectiveness and costs of two different implementation strategies. These goals will be achieved through three specific aims, guided by the HPRC Dissemination and Implementation Framework. The research team will conduct qualitative audience research with state and local health department directors and local health department staff to refine training and support approaches (Aim 1); conduct a hybrid type III trial comparing standard and enhanced technical assistance combined with online training for Connect to Wellness (Aim 2); and measure the costs of each strategy, both to the local health departments and to the research team (Aim 3). The proposed activities will increase the reach of Connect to Wellness across the United States to small employers with limited capacity for and access to EBIs. These activities will also advance implementation science by measuring the impact and costs of implementation strategies offering different levels of ongoing support. The findings from this project may inform implementation strategies for other workplace health promotion programs focused on EBIs and small worksites, as well as a variety of implementation efforts that include partnerships with LHDs. Aim 2 and Aim 3 activities will be achieved through the randomized trial described in the protocol registered on ClinicalTrials.gov.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Washington
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Seattle, Washington, United States, 98105
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Staff in local health departments in United States (50 states and District of Columbia)
- Local health department willing to support one or more staff to participate for 24 months
- Local health department willing to attempt to recruit 15 or more worksites to participate in Connect to Wellness over 24 months
- Able to speak and read English
Exclusion Criteria:
-
Study Plan
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 |
---|---|
Active Comparator: Standard
Local health department staff in the standard arm will receive Connect to Wellness intervention materials, multiple real-time training sessions delivered via webinar, access to a web-based platform that includes all intervention and training materials and has features allowing them to communicate with each other and with research staff, and a monthly group technical assistance call.
|
The research team will train LHD staff and offer them technical assistance to work with small worksites.
LHD staff will be trained to deliver the Connect to Wellness program to worksites.
Connect to Wellness is a program to disseminate EBIs to small worksites.
Worksites receive guidance about EBIs and ongoing implementation assistance from a trained interventionist.
In this study, LHD staff will be the interventionists.
Worksites participating in Connect to Wellness complete three phases of activities, Assessment, Recommendations, and Implementation.
LHD staff will receive Connect to Wellness intervention materials, multiple webinars delivered in real-time, access to a comprehensive intervention and training platform with features that allow them to connect with each other and with research staff, and group technical assistance calls to support their ability to recruit worksites in their communities and deliver Connect to Wellness to these worksites.
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Experimental: Enhanced
Local health department staff in the enhanced arm will receive all the Connect to Wellness intervention materials, training, and support as described for the standard arm.
In addition, the participants in the enhanced arm can telephone research staff at will to receive additional technical assistance.
Research staff will also contact participants monthly, if they do not request assistance proactively.
|
The research team will train LHD staff and offer them technical assistance to work with small worksites.
LHD staff will be trained to deliver the Connect to Wellness program to worksites.
Connect to Wellness is a program to disseminate EBIs to small worksites.
Worksites receive guidance about EBIs and ongoing implementation assistance from a trained interventionist.
In this study, LHD staff will be the interventionists.
Worksites participating in Connect to Wellness complete three phases of activities, Assessment, Recommendations, and Implementation.
LHD staff will receive Connect to Wellness intervention materials, multiple webinars delivered in real-time, access to a comprehensive intervention and training platform with features that allow them to connect with each other and with research staff, and group technical assistance calls to support their ability to recruit worksites in their communities and deliver Connect to Wellness to these worksites.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Worksites
Time Frame: 24 months
|
Number of worksites each local health department recruits and delivers Connect to Wellness to
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24 months
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Worksite EBI implementation
Time Frame: 12 months
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The evidence-based intervention implementation score for each worksite that participates in the Connect to Wellness intervention; possible score range is 0-100, with higher numbers reflecting better outcomes.
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12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LHD costs
Time Frame: 24 months
|
Cost to local health departments, per worksite, to deliver Connect to Wellness
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margaret A Hannon, PhD, MPH, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00004627
- 2R01CA160217 (U.S. NIH Grant/Contract)
- NCI-2021-02876 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- RG1121453 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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