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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EX program participant
Individual who signs up for digital tobacco cessation program (EX program)
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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