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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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06644664
Enrollment
292
Registered
2024-10-16
Start date
2024-09-24
Completion date
2026-02-02
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco-Related Carcinoma

Keywords

Sexual and Gender Minorities, Health Communication, Tobacco Products, Cigarettes, Electronic Nicotine Delivery Systems, E-cigarettes, young adult, text messaging

Brief summary

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.

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.

Interventions

BEHAVIORALHealth Education

Receive control MMS messages

OTHERInterview

Ancillary studies

BEHAVIORALSmoking Cessation Intervention

Receive AR MMS messages

OTHERSurvey Administration

Ancillary studies

Receive check-in text message

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants are blinded to their randomization category (absolute risks, relative risks, or control)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total tobacco cessationAt 12 weeks post-baseline2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all.
Acceptability of multimedia messaging service (MMS) anti-polytobacco messagesAt 6-week post-enrollmentIn 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?
Feasibility of MMS anti-polytobacco messagesAt 6-weeks post-enrollment6 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.

Secondary

MeasureTime frameDescription
Switching to exclusive electronic nicotine delivery system (ENDS) useAt 6- and 12-weeks post-baseline2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all.
Risk perceptionsAt 6- and 12-weeks post-baseline3 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?
Behavioral intentionsDifference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline2 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.
Serious quit attemptsDifference between conditions in quit attempts from screener, and at 6 and 12-week post baseline2 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJoanne G Patterson

Ohio State University Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026