Health BehaviorNCT03930420
Training LHDs to Disseminate Evidence-Based Interventions to Small Worksites
A study testing Connect to Wellness in people with Health Behavior, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Connect to Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training Local Health Departments to Disseminate Evidence-Based Interventions to Small and Low-Wage Worksites
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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Connect to Wellness
- Keywords
- evidence-based practice, implementation science, public health practice
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect to WellnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | 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. Receives: Behavioral: Connect to Wellness |
| Enhanced | Experimental | 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. Receives: Behavioral: Connect to Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Worksites
The outcome measure is the average number of worksites recruited by the health departments
Measured: 24 months
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 higher EBI implementation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Oct 2020
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health BehaviorStudies 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
- 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)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Association of Chronic Disease Directors, 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
- NCT03930420
- Sponsor's protocol ID
- STUDY00004627
- Other IDs
- 2R01CA160217, NCI-2021-02876, RG1121453
- Status last verified
- Jun 2025
- First submitted
- 24 Apr 2019
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Local Health Departments to Disseminate Evidence-Based Interventions to Small and Low-Wage Worksites
- ClinicalTrials.gov ID
- NCT03930420
- Acronym / sponsor ID
- STUDY00004627
- Conditions
- Health Behavior
- Keywords
- evidence-based practice, implementation science, public health practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Association of Chronic Disease Directors, National Cancer Institute (NCI)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 17 Jul 2025
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 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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: Connect to WellnessLocal 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. |
| Enhanced | Experimental | Behavioral: Connect to WellnessLocal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Connect to WellnessThe 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. | Behavioural | Enhanced, Standard |
Primary outcome
Number of Worksites
Time frame: 24 months
The outcome measure is the average number of worksites recruited by the health departments
Worksite EBI Implementation
Time frame: Baseline
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 higher EBI implementation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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 Connect to Wellness in people with Health Behavior, 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 4 inclusion and 1 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 17 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Worksites (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.