Be A Quitter: Illinois Small Business EX Program Dissemination

Disseminate the EX tobacco cessation program to Illinois small businesses

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project is designed to provide small businesses throughout Illinois the opportunity to provide a proven tobacco cessation program to their employees at no or reduced cost to the business. The investigators will examine practices that facilitate dissemination of the program, employee usage, as well as benefits of enrollment for individual's mental health, workplace functioning, and family relationships.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois Extension

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Resident of Illinois
  • 18 years of age or older
  • Current tobacco user
  • Seeking to quit tobacco use and willing to participate in the EX program
  • Willing to answer surveys at 5 occasions over the course of a year
  • Employed at collaborating business in Illinois

Exclusion Criteria:

  • Not employed at collaborating business in Illinois

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EX program participant
Individual who signs up for digital tobacco cessation program (EX program)
Quit plan with interactive exercises, educational videos, and tailored text messages and emails; peer support; coach chatting; nicotine replacement therapy (patches, gum, or lozenges). All components are self-selected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant enrollment
Time Frame: Through study completion, an average of 1 year
Number of individuals that enroll
Through study completion, an average of 1 year
Quit planning
Time Frame: Through study completion, an average of 1 year
Number of steps completed for quit plan
Through study completion, an average of 1 year
Business enrollment
Time Frame: Through study completion, an average of 1 year
Number of businesses that enroll
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Quality of Life
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
1 item quality of life measure from World Health Organization brief quality of life assessment (1-5, higher is better quality of life)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
General Health
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
4 items from RAND (Research and Development) Corporation Short Form Health Survey (1-4, higher is better health)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Work functioning
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
1 item of general ability to function at work (1-5 scale, higher is better working functioning)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Exercise
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
1 item of frequency of exercise (1-6, higher is more weekly exercise)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Psychological distress
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Kessler 6 item psychological distress (1-5, higher is more distress)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Alcohol Use
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
PROMIS (Patient-Reported Outcomes Measurement Information System) 7 item problematic alcohol use (1-5, higher is more problematic alcohol use)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Anger
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
NIH PROMIS 5 item anger measure (1-5, higher is more anger)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Couple Relationship Satisfaction
Time Frame: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
4 item Couple Satisfaction Index (3-21 [summed score], higher is more satisfaction)
Baseline, 3 month, 6 month, 9 month, and 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 30, 2025

First Posted (Actual)

July 31, 2025

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 21520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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