Clinical trial NCT06644664: Nicotine and Tobacco Message Framing to Change Smoking Behavior in Diverse Groups of Young Adult Smokers
Official title: The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults: Aim 3 Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco-Related Carcinoma
Keywords: Sexual and Gender Minorities
Health Communication
Tobacco Products
Cigarettes
Electronic Nicotine Delivery Systems
E-cigarettes
young adult
text messaging
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total tobacco cessation
timeFrame: At 12 weeks post-baseline
measure: Acceptability of multimedia messaging service (MMS) anti-polytobacco messages
timeFrame: At 6-week post-enrollment
measure: Feasibility of MMS anti-polytobacco messages
timeFrame: At 6-weeks post-enrollment
Secondary outcomes:
measure: Switching to exclusive electronic nicotine delivery system (ENDS) use
timeFrame: At 6- and 12-weeks post-baseline
measure: Risk perceptions
timeFrame: At 6- and 12-weeks post-baseline
measure: Behavioral intentions
timeFrame: Difference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline
measure: Serious quit attempts
timeFrame: Difference between conditions in quit attempts from screener, and at 6 and 12-week post baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Joanne G Patterson
role: PRINCIPAL_INVESTIGATOR
References: