Nicotine and Tobacco Message Framing to Change Smoking Behavior in Diverse Groups of Young Adult Smokers

March 24, 2026 updated by: Joanne Patterson, Ohio State University Comprehensive Cancer Center

The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults: Aim 3 Randomized Control Trial (RCT)

This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.

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

PRIMARY OBJECTIVES:

I. Assess the feasibility of delivering mobile multimedia messaging (MMS) anti-tobacco messages developed in the K99 to LGBT young adults via texting.

II. Estimate effect sizes of exposure to anti-tobacco messages on risk perceptions and tobacco use over time.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive AR anti-polytobacco MMS messages 3 times a week (TIW) and a check-in text message once a week (QW) for a total of 6 weeks.

ARM II: Participants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks.

ARM III: Participants receive control MMS messages on health risks of ultraviolet (UV)/sun exposure TIW and a check-in text message QW for a total of 6 weeks.

All participants also receive smoking cessation resources via email during follow up.

After completion of study intervention, participants are followed up at 6 and 12 weeks.

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.
292

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-35 years old
  • Self-identify as LGBTQ+
  • Able to speak English fluently
  • An ever user of ENDS and combustible tobacco who currently use ENDS, combustible cigarettes, or both ENDS and combustible cigarettes
  • Currently reside in the United States (US)
  • Have a mobile phone through a U.S. carrier with MMS messaging and can send and receive text messages for study participation
  • Access to the internet with Zoom capabilities

Exclusion Criteria:

  • Have a landline or Voice Over Internet Protocol (VOIP) phone number

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Arm I (Absolute Risk messages)
Participants receive AR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Behavioral: Smoking Cessation Intervention
Receive AR MMS messages
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Behavioral: Smoking Cessation Intervention
Receive RR MMS messages
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Behavioral: Smoking Cessation Intervention
Receive smoking cessation resources
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Other: Text Message-Based Navigation Intervention
Receive check-in text message
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Experimental: Arm II (Relative Risk messages)
Participants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Behavioral: Smoking Cessation Intervention
Receive AR MMS messages
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Behavioral: Smoking Cessation Intervention
Receive RR MMS messages
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Behavioral: Smoking Cessation Intervention
Receive smoking cessation resources
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Other: Text Message-Based Navigation Intervention
Receive check-in text message
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Active Comparator: Arm III (control messages)
Participants receive control MMS messages on health risks of UV/sun exposure TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.
Other: Survey Administration
Ancillary studies
Behavioral: Smoking Cessation Intervention
Receive AR MMS messages
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Behavioral: Smoking Cessation Intervention
Receive RR MMS messages
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Behavioral: Smoking Cessation Intervention
Receive smoking cessation resources
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
Other: Text Message-Based Navigation Intervention
Receive check-in text message
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Behavioral: Health Education
Receive control MMS messages

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
Total tobacco cessation
Time Frame: At 12 weeks post-baseline
2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all.
At 12 weeks post-baseline
Acceptability of multimedia messaging service (MMS) anti-polytobacco messages
Time Frame: At 6-week post-enrollment
In a qualitative interview, Participants will be asked the following question: How did you find participating in a study with images sent via text message? How smoothly would you say it went?
At 6-week post-enrollment
Feasibility of MMS anti-polytobacco messages
Time Frame: At 6-weeks post-enrollment
6 items per study arm. Experimental arms 1 and 2: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding nicotine and tobacco use. Control Group: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding sun safety.
At 6-weeks post-enrollment

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
Switching to exclusive electronic nicotine delivery system (ENDS) use
Time Frame: At 6- and 12-weeks post-baseline
2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all.
At 6- and 12-weeks post-baseline
Risk perceptions
Time Frame: At 6- and 12-weeks post-baseline
3 items. 2 items on a 5 point likert scale where 1= Not at all harmful and 5= Extremely harmful. How harmful do you think nicotine vapes, e-cigarettes, or other electronic products are to health? How harmful do you think cigarettes are to health?; 1 item with 3 response options: Less harmful, About the same, More harmful. Is using nicotine vapes, e-cigarettes or other electronic nicotine products less harmful, about the same, or more harmful than smoking cigarettes?
At 6- and 12-weeks post-baseline
Behavioral intentions
Time Frame: Difference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline
2 Items. Are you seriously thinking of quitting nicotine vapes? and Are you seriously thinking of quitting cigarettes? 5 response options: Yes, within the next 30 days; Yes, within the next 6 months; Yes, within the next year; Yes, but not within the next year; No, not thinking of quitting.
Difference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline
Serious quit attempts
Time Frame: Difference between conditions in quit attempts from screener, and at 6 and 12-week post baseline
2 items. During the PAST 12 MONTHS, how many times have you stopped vaping nicotine for 1 day or longer because you were trying to quit? and During the PAST 12 MONTHS, how many times have you stopped vaping nicotine for 1 day or longer because you were trying to quit? 5 response options: None; 1-2 times; 3-5 times; 6-10 times; More than 10 times
Difference between conditions in quit attempts from screener, and at 6 and 12-week post baseline

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.
Ohio State University Comprehensive Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanne G Patterson, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
September 24, 2024

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.
February 2, 2026

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.
February 2, 2026

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).
October 15, 2024

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.
October 15, 2024

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.
October 16, 2024

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.
March 30, 2026

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.
March 24, 2026

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, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • OSU-23436
  • NCI-2024-04955 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R00CA260718 (U.S. NIH Grant/Contract)

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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