Tobacco UseNCT07097194
Be A Quitter: Illinois Small Business EX Program Dissemination
A study testing EX program in people with Tobacco Use, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
Disseminate the EX tobacco cessation program to Illinois small businesses Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- EX program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not employed at collaborating business in Illinois
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Extension
Urbana, Illinois, 61801
About this study
Disseminate the EX tobacco cessation program to Illinois small businesses
Read the 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.
- Conditions
- Tobacco Use
- Being tested
- EX program
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EX programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EX program participant | Experimental | Individual who signs up for digital tobacco cessation program (EX program) Receives: Behavioral: EX program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant enrollment
Number of individuals that enroll
Measured: Through study completion, an average of 1 year
Quit planning
Number of steps completed for quit plan
Measured: Through study completion, an average of 1 year
Business enrollment
Number of businesses that enroll
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
General Quality of Life
1 item quality of life measure from World Health Organization brief quality of life assessment (1-5, higher is better quality of life)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
General Health
4 items from RAND (Research and Development) Corporation Short Form Health Survey (1-4, higher is better health)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Work functioning
1 item of general ability to function at work (1-5 scale, higher is better working functioning)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Exercise
1 item of frequency of exercise (1-6, higher is more weekly exercise)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Psychological distress
Kessler 6 item psychological distress (1-5, higher is more distress)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Alcohol Use
PROMIS (Patient-Reported Outcomes Measurement Information System) 7 item problematic alcohol use (1-5, higher is more problematic alcohol use)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Anger
NIH PROMIS 5 item anger measure (1-5, higher is more anger)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Couple Relationship Satisfaction
4 item Couple Satisfaction Index (3-21 [summed score], higher is more satisfaction)
Measured: Baseline, 3 month, 6 month, 9 month, and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start19 Nov 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097194
- Sponsor's protocol ID
- 21520
- Status last verified
- Mar 2025
- First submitted
- 18 Jul 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be A Quitter: Illinois Small Business EX Program Dissemination
- ClinicalTrials.gov ID
- NCT07097194
- Acronym / sponsor ID
- 21520
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Disseminate the EX tobacco cessation program to Illinois small businesses
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EX program participant | Experimental | Behavioral: EX programIndividual who signs up for digital tobacco cessation program (EX program) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Not employed at collaborating business in Illinois
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 |
|---|---|---|
| EX programQuit 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. | Behavioural | EX program participant |
Primary outcome
Participant enrollment
Time frame: Through study completion, an average of 1 year
Number of individuals that enroll
Quit planning
Time frame: Through study completion, an average of 1 year
Number of steps completed for quit plan
Business enrollment
Time frame: Through study completion, an average of 1 year
Number of businesses that enroll
8 secondary outcomes
General Quality of Life
Time frame: 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
Work functioning
Time frame: 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
Psychological distress
Time frame: 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
Anger
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EX program in people with Tobacco Use, run by University of Illinois at Urbana-Champaign 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 6 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 31 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant enrollment (time frame: Through study completion, an average of 1 year). The study lists 3 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 31 Jul 2025.