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

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: Completed
• Conditions: Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Behavioral: Smoking Cessation Intervention; Behavioral: Smoking Cessation Intervention; Behavioral: Smoking Cessation Intervention; Other: Text Message-Based Navigation Intervention; Behavioral: Health Education

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: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Total tobacco cessation	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	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	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

Outcome Measure	Measure Description	Time Frame
Switching to exclusive electronic nicotine delivery system (ENDS) use	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	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	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	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

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Joanne G Patterson, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Our Health Matters

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Actual): February 2, 2026
• Study Completion (Actual): February 2, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: young adult; Sexual and Gender Minorities; Cigarettes; text messaging; Health Communication; E-cigarettes; Electronic Nicotine Delivery Systems; Tobacco Products
• Additional Relevant MeSH Terms: Behavior; Smoking; Sexual Behavior; Vaping; Coitus; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Manufactured Materials; Technology, Industry, and Agriculture; Interviews as Topic; Smoking Devices
• Other Study ID 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