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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Training LHDs to Disseminate Evidence-Based Interventions to Small Worksites

Clinicaltrials.gov identifier NCT03930420

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted November 3, 2020

Study Description

Brief 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.

  • Condition or Disease:Health Behavior
  • Intervention/Treatment: Behavioral: Connect to Wellness
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: The research team will use a hybrid type III study design to conduct a randomized controlled trial (RCT) comparing the effect of standard Connect to Wellness training and TA to the effect of training plus enhanced TA on primary outcomes.
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: Training Local Health Departments to Disseminate Evidence-Based Interventions to Small and Low-Wage Worksites
  • Actual Study Start Date: October 2020
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: April 2023
Arms and interventions
Arm Intervention/treatment
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.
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.
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Number of Worksites [ Time Frame: 24 months ]
    Number of worksites each local health department recruits and delivers Connect to Wellness to
  • 2. Worksite EBI implementation [ Time Frame: 12 months ]
    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.
  • Other Outcome Measures: 1. LHD costs [ Time Frame: 24 months ]
    Cost to local health departments, per worksite, to deliver Connect to Wellness
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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:

-

Contacts and Locations
Contacts

Contact: Margaret A Hannon, PhD 206-616-7859 peggyh@uw.edu

Contact: Kristen Hammerback, MA 206-616-3146 khammerb@uw.edu

Locations

United States, Washington
University of Washington
Seattle

Sponsors and Collaborators

University of Washington

National Association of Chronic Disease Directors

National Cancer Institute (NCI)

Investigators

Principal Investigator: Margaret A Hannon, PhD, MPH University of Washington

More Information
  • Responsible Party: University of Washington
  • ClinicalTrials.gov Identifier: NCT03930420 History of Changes
  • Other Study ID Numbers: STUDY00004627, 2R01CA160217
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: November 3, 2020
  • Last Verified: November 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: The research team is committed to making the data collected available to other scientists and the public after a reasonable period of time for main analyses and the publication of results. The data and the related documentation will be archived at the Health Promotion Research Center and will be available (in a de-identified format) upon request.
  • Supporting Materials: Study Protocol, Informed Consent Form (ICF)
  • Time Frame: Data will be available starting in May 2024.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Washington: evidence-based practice
    implementation science
    public health practice