- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07097194
- Original Trial
Be A Quitter: Illinois Small Business EX Program Dissemination
July 30, 2025 updated by: University of Illinois at Urbana-Champaign
Disseminate the EX tobacco cessation program to Illinois small businesses
Study Overview
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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