NCT03930420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

June 1, 2025

Enrollment Period

3.5 years

First QC Date

April 24, 2019

Results QC Date

March 30, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

evidence-based practiceimplementation sciencepublic health practice

Outcome Measures

Primary Outcomes (2)

  • Number of Worksites

    The outcome measure is the average number of worksites recruited by the health departments

    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.

    Baseline

Study Arms (2)

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.

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.

Behavioral: Connect to Wellness

Interventions

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.

EnhancedStandard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

This study started at the onset of the COVID-19 pandemic; this was an overwhelming barrier to completing study activities for our health department partners. Those that participated were committed to the research goals, but most were unable to meet recruitment or data collection needs. We did additional research with health departments to better understand these barriers, and with employers/employees to identify post-pandemic workplace health needs of small, low-wage businesses and employees.

Results Point of Contact

Title
Margaret Hannon, PhD
Organization
University of Washington

Study Officials

  • Margaret A Hannon, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor: School of Public Health

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

October 1, 2020

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

July 17, 2025

Results First Posted

July 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available starting in May 2024.

Locations