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

NCT06644664 — Not applicable, Completed, 292 participants, Ohio State University Comprehensive Cancer Center

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

RegistryNCT06644664
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment292 (Actual)
SponsorOhio State University Comprehensive Cancer Center (Other); collaborators: National Cancer Institute (NCI)
ConditionsTobacco-Related Carcinoma
InterventionsHealth Education, Interview, Smoking Cessation Intervention, Survey Administration, Text Message-Based Navigation Intervention (Behavioral, other)
Datesstart 2024-09-24, primary completion 2026-02-02, completion 2026-02-02, first posted 2024-10-16, last updated 2026-03-30
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Arm I (Absolute Risk messages)ExperimentalOther: Interview; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation InterventionParticipants 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.
Arm II (Relative Risk messages)ExperimentalOther: Interview; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation InterventionParticipants 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.
Arm III (control messages)Active comparatorBehavioral: Health Education; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation InterventionParticipants 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.
  • Health Education (Behavioral): Receive control MMS messages
  • Interview (Other): Ancillary studies
  • Smoking Cessation Intervention (Behavioral), also known as Smoking and Tobacco Use Cessation Interventions: Receive AR MMS messages
  • Smoking Cessation Intervention (Behavioral), also known as Smoking and Tobacco Use Cessation Interventions: Receive RR MMS messages
  • Smoking Cessation Intervention (Behavioral), also known as Smoking and Tobacco Use Cessation Interventions: Receive smoking cessation resources
  • Survey Administration (Other): Ancillary studies
  • Text Message-Based Navigation Intervention (Other), also known as Automated Text Message-Based Navigation, Text Message-Based Navigation: Receive check-in text message

+Outcome measures

Primary outcomes

  • Total tobacco cessation [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.
  • Acceptability of multimedia messaging service (MMS) anti-polytobacco messages [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?
  • Feasibility of MMS anti-polytobacco messages [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.

Secondary outcomes

  • Switching to exclusive electronic nicotine delivery system (ENDS) use [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.
  • Risk perceptions [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?
  • Behavioral intentions [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.
  • Serious quit attempts [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

+Eligibility

Sex: All, ages: 18 Years to 35 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Ohio State University Comprehensive Cancer CenterColumbus, OhioUnited States

+Investigators

  • Joanne G Patterson, Principal investigator, Ohio State University Comprehensive Cancer Center

+Funding

NIH grants: R00CA260718

My Notes