Enhancing Source Credibility in Tobacco Regulatory Communications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 845
- 试验地点
- 1
- 主要终点
- Quit Intentions
研究概览
简要总结
This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial. The investigators hypothesize that cigarette constituent messages will increase intention to quit compared to messages about littering cigarettes (the control). The investigators also hypothesize that constituent messages that include FDA source and quit information will increase intention to quit compared to messages without that information.
详细描述
The Family Smoking Prevention and Tobacco Control Act delegates the U.S. Food and Drug Administration (FDA) to communicate the risks of smoking to the public, among other tobacco regulatory responsibilities. Little research exists about how FDA, as a regulatory agency, should develop and deliver these messages, and whether they should include their source information on the ads. This study will assess the impact of cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.
Recruitment: People interested in participating will complete an online screener. Study staff will invite people eligible based on the screener to enroll in the study.
Informed Consent: The consent form will be shared with people who are eligible based on the screener in the invitation email. At the beginning of the baseline survey, participants will again review the consent form and will be asked to provide consent in order to enroll in the study.
Randomization: At the end of the baseline survey, survey software will randomly assign participants to one of the three study arms. Participants will have an equal chance of being randomized to each study arm.
Assessment: Participants will complete 18 computer based surveys during the study. The first baseline survey will take around 20 minutes to complete on day 0. Participants will then receive a survey each morning for days 1-15 that will include behavior measures as well as their assigned study intervention. These surveys will take approximately 5 minutes to complete. Participants will then complete a 20-minute survey on day 16, and day 32.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have smoked at least 100 cigarettes in his or her lifetime
- •Currently smoke cigarettes every day or some days
- •Work or home access to the internet
- •Email account that is regularly used
- •Lives in the US
- •Comfortable taking a survey in English
- •Able to complete a survey on a computer
- •Able to complete surveys delivered via email
- •Able to complete 3, 20 minute surveys during the study
- •Able to complete surveys in the morning for 15 days
排除标准
- •Currently using pharmacotherapy, a quitline, or a quit smoking program or support group for smoking cessation
- •Participated in a research study about smoking cigarettes or using other tobacco products in the last 3 months
研究组 & 干预措施
Constituent message with FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.
干预措施: Constituent message with FDA and quitline (Behavioral)
Constituent message without FDA and quitline
Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.
干预措施: Constituent message without FDA and quitline (Behavioral)
Littering message (Control)
Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.
干预措施: Littering message (Control) (Behavioral)
结局指标
主要结局
Quit Intentions
时间窗: day 16
Average quit intention score measured at 16 days by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
次要结局
- Number of Cigarettes Smoked Each Day(days 1-15)
- Number of Cigarettes Forgone Each Day(days 1-15)
- Number of Cigarettes Butted Out Each Day(days 1-15)
- Quit Attempts During the Study(days 16 and 32)
- Recall of Quitline Phone Number(day 16)
- Awareness of Quitline(day 16)
- Intention to Use the Quitline(days 16 and 32)
- Self Efficacy(days 16 and 32)
- Use of Quitline During the Study(days 16 and 32)
- Quit Intentions(day 32)
- Response Efficacy(days 16 and 32)
研究者
Adam Goldstein, MD, MPH
Professor
University of North Carolina, Chapel Hill