Message Effects on Perceptions of Oral Nicotine Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 607
- 试验地点
- 1
- 主要终点
- Perceived Message Effectiveness
研究概览
简要总结
This clinical trial tests the effect of different types of oral nicotine pouch (ONP) messaging to communicate risk of using these products for young adults. Tobacco use remains the leading preventable cause of death due to cancer and other outcomes in the U.S. Tobacco products vary in the health risks they pose to users. Combustible tobacco products such as cigarettes pose higher risks than noncombustible nicotine and tobacco products such as ONPs. Despite the lower harm potential of ONPs for those who use tobacco, there are potential risks to non-users, especially susceptible young adults. Different types of messaging that include information about absolute risk and addiction, risks of ONPs relative to cigarettes and e-cigarettes, ability to use ONPs instead of cigarettes/e-cigarettes (switching), and the potential benefits of doing so and potential benefits of switching to ONPs may be more or less effective in communicating risk for young adults.
详细描述
PRIMARY OBJECTIVES:
I. To test the effects of ONP messages on:
Ia. message response (e.g., perceived effectiveness) and Ib. ONP curiosity and intentions.
SECONDARY OBJECTIVE:
I. To test the effects of ONP messages on ONP harms beliefs and perceptions; and motivation to quit cigarettes/e-cigarettes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •United States (U.S.) young adults aged 18 - 30 years
- •Current cigarette smokers. Current smokers are those who smoked 100 lifetime cigarettes and now are smoking every day or some days
- •Current e-cigarette users. Current e-cigarette users are those who have ever tried an e-cigarette or other electronic vaping product even once and are now using every day or some days
- •Susceptible nonusers of cigarettes or e-cigarettes. Susceptible nonusers are those who have never tried cigarettes/e-cigarettes and respond with any response other than "definitely not" to any of the following items:
- •"Have you ever been curious about using cigarettes/e-cigarettes?"
- •"Do you think that you will try a(n) cigarette/e-cigarette soon?"
- •"If one of your best friends were to offer you a(n) cigarette/e-cigarette, would you use it?"
- •"Do you think you will use cigarettes/e-cigarettes in the next year?"
排除标准
- •Participants who do not meet age and tobacco-related criteria, unable to complete study procedures online in English, or do not reside in the U.S. will be excluded
研究组 & 干预措施
Arm V (no messaging)
Participants do not receive messaging.
干预措施: Survey Administration (Other)
Arm IV (Switching to ONPs)
Participants receive messaging regarding switching to ONPs. Participants engage with the content at their discretion.
干预措施: Survey Administration (Other)
Arm I (absolute risk of ONPs)
Participants receive messaging regarding absolute risk and addiction beliefs. Participants engage with the content at their discretion.
干预措施: Behavioral Intervention (Behavioral)
Arm I (absolute risk of ONPs)
Participants receive messaging regarding absolute risk and addiction beliefs. Participants engage with the content at their discretion.
干预措施: Survey Administration (Other)
Arm II (efficacy of ONPs)
Participants receive messaging regarding self and response efficacy of ONPs. Participants engage with the content at their discretion.
干预措施: Behavioral Intervention (Behavioral)
Arm II (efficacy of ONPs)
Participants receive messaging regarding self and response efficacy of ONPs. Participants engage with the content at their discretion.
干预措施: Survey Administration (Other)
Arm III (relative risk of ONPs)
Participants receive messaging regarding risk of ONPs relative to cigarettes and e-cigarettes. Participants engage with the content at their discretion.
干预措施: Behavioral Intervention (Behavioral)
Arm III (relative risk of ONPs)
Participants receive messaging regarding risk of ONPs relative to cigarettes and e-cigarettes. Participants engage with the content at their discretion.
干预措施: Survey Administration (Other)
Arm IV (Switching to ONPs)
Participants receive messaging regarding switching to ONPs. Participants engage with the content at their discretion.
干预措施: Behavioral Intervention (Behavioral)
结局指标
主要结局
Perceived Message Effectiveness
时间窗: This assessment is administered immediately after participants view study messages.
Perceived message effectiveness will be assessed as the mean of three items asking how much the messages made participants concerned about the health effects of ONP use compared to cigarettes/e-cigarettes, made ONP use seem unpleasant compared to cigarettes/e-cigarettes, and discouraged them from wanting to use ONPs compared to cigarettes/e-cigarettes. Responses range from 1 "a great deal" to 5 "not at all," and will be reverse coded and averaged to create a score where higher values indicate greater perceived effectiveness. Higher perceived effectiveness is considered a better outcome.
Perceived Message Strength
时间窗: This assessment is administered immediately after participants view study messages.
Perceived message strength will be assessed as the mean of seven items assessing responses such as the messages grasped attention, were believable, and interesting. Responses range from 1 "strongly agree" to 7 "strongly disagree," and will be reverse-coded and averaged to create a score where higher values indicate greater perceived strength. Higher perceived strength is considered a better outcome.
Counterarguing
时间窗: This assessment is administered immediately after participants view study messages.
Counterarguing will be assessed as the mean of three items asking whether participants criticized the messages while viewing them, thought of points that went against what was being said while viewing the messages, and were skeptical of what was being said while viewing the messages. Responses range from 1 "very much" to 7 "not at all" and will be reverse-coded and averaged to create a score where higher values indicate greater counterarguing. Lower counterarguing is considered a better outcome.
Negative Feelings
时间窗: This assessment is administered immediately after participants view study messages.
Negative feelings will be assessed as the mean of seven items asking whether participants felt frightened, anxious, nervous, worried, irritated, angry, and annoyed. Responses range from 1 "extremely" to 4 "not at all." Responses will be reverse-coded and averaged to create a score where higher values indicate greater negative feelings. Lower negative feelings are considered a better outcome.
Positive Feelings
时间窗: This assessment is administered immediately after participants view study messages.
Positive feelings will be assessed as the mean of three items asking whether participants felt interested, excited, and happy. Responses range from 1, "extremely," to 4, "not at all." Responses will be reverse-coded and averaged to create a score where higher values indicate greater positive feelings. Higher positive feelings are considered a better outcome.
Oral Nicotine Pouch Use Curiosity
时间窗: This assessment is administered immediately after participants view study messages.
Oral nicotine pouch use curiosity will be assessed with the item, "Overall, how curious are you about trying nicotine pouches?" Response options range from 1 "not at all curious" to 7 "very curious." Lower curiosity is considered a better outcome.
Oral Nicotine Pouch use intentions
时间窗: This assessment is administered immediately after participants view study messages.
Oral nicotine pouch use intentions will be assessed with the item "Which of the following best describes your thinking about using nicotine pouches?" Response options range from 1 "I am planning to switch to/try within the next month," to 4 "I am not interested in switching to/trying nicotine pouches." Responses will be reverse-coded, so higher values indicate greater intention to use nicotine pouches. Lower intention to use nicotine pouches is considered a better outcome.
次要结局
- Perceived Harm of Oral Nicotine Pouches(This assessment is administered immediately after participants view study messages.)
- Perceived Addictiveness of Oral Nicotine Pouches(This assessment is administered immediately after participants view study messages.)
- Worry About Harm of Oral Nicotine Pouches(This assessment is administered immediately after participants view study messages.)
- Worry About Addictiveness of Oral Nicotine Pouches(This assessment is administered immediately after participants view study messages.)
- Motivation to Quit Smoking(This assessment is administered immediately after participants view study messages.)
- Motivation to Quit E-Cigarettes(This assessment is administered immediately after participants view study messages.)
研究者
Mahmood Alalwan
Principal Investigator
Ohio State University Comprehensive Cancer Center