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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03930420
Other study ID # STUDY00004627
Secondary ID 2R01CA160217NCI-
Status Terminated
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date March 31, 2024

Study information

Verified date April 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed project will advance implementation science by comparing the effectiveness of different levels of technical support in an important but understudied community-based setting: local health departments. The proposed project will also bring Connect to Wellness, an evidence-based approach to disseminating evidence-based interventions and providing implementation support to small worksites, to 40 local health departments and worksites in their communities across the United States. Findings will identify the best approach for national scale-up of Connect to Wellness.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Connect to Wellness
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.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Washington National Association of Chronic Disease Directors, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other LHD costs Cost to local health departments, per worksite, to deliver Connect to Wellness 24 months
Primary Number of Worksites Number of worksites each local health department recruits and delivers Connect to Wellness to 24 months
Primary Worksite EBI implementation 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. 12 months
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