The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults: Aim 3 Randomized Control Trial (RCT)
| Registry | NCT06644664 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 292 (Actual) |
| Sponsor | Ohio State University Comprehensive Cancer Center (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Tobacco-Related Carcinoma |
| Interventions | Health Education, Interview, Smoking Cessation Intervention, Survey Administration, Text Message-Based Navigation Intervention (Behavioral, other) |
| Dates | start 2024-09-24, primary completion 2026-02-02, completion 2026-02-02, first posted 2024-10-16, last updated 2026-03-30 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm I (Absolute Risk messages) | Experimental | Other: Interview; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation Intervention | 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. |
| Arm II (Relative Risk messages) | Experimental | Other: Interview; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation Intervention | 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. |
| Arm III (control messages) | Active comparator | Behavioral: Health Education; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation Intervention | 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. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus, Ohio | United States |
NIH grants: R00CA260718