The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults: Aim 3 Randomized Control Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Total tobacco cessation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to their randomization category (absolute risks, relative risks, or control)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Have a landline or Voice Over Internet Protocol (VOIP) phone number
结局指标
主要结局
Total tobacco cessation
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Switching to exclusive electronic nicotine delivery system (ENDS) use(At 6- and 12-weeks post-baseline)
- Risk perceptions(At 6- and 12-weeks post-baseline)
- Behavioral intentions(Difference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline)
- Serious quit attempts(Difference between conditions in quit attempts from screener, and at 6 and 12-week post baseline)
研究者
Joanne Patterson
Principal Investigator
Ohio State University Comprehensive Cancer Center