A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,149
- 试验地点
- 4
- 主要终点
- Quit attempts
研究概览
简要总结
The purpose of this randomized controlled trial is to determine whether graphic health warnings on cigarette packs are more effective than the existing Surgeon General's warning on cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate graphic warnings have been informative, they have used psychological outcomes, such as attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts). Furthermore, they typically expose participants to warnings in controlled but artificial experimental settings for a short period of time, using much lower frequency and shorter duration of warning exposure than found in the real world. This study addresses these issues by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have their cigarette packs labeled with either a graphic warning or a Surgeon General's warning for four weeks.
Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized to receive a Surgeon General's label on their cigarette packs.
Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon General's label on their cigarette packs, controlling for baseline quit intentions.
详细描述
The U.S. Food and Drug Administration (FDA) proposed 9 new graphic warnings for cigarette packs in June 2011 to comply with the Family Smoking Prevention and Tobacco Control Act. However, tobacco industry litigation has delayed implementation of graphic warnings. A court ruling that struck down the labels criticized FDA for failing to "present any data - much less the substantial evidence required under the federal law - showing that enacting their proposed graphic warnings will accomplish the agency's stated objective of reducing smoking rates." This study will address this critique head-on by rigorously testing the impact of the graphic warnings on quit attempts in a randomized control trial.
Recruitment: Smokers will first undergo screening online or call the study center to complete the screening questionnaire over the phone. Study staff will schedule eligible smokers for 5 in-person visits. For each of their first 4 visits, smokers will be asked to bring the number of cigarettes they expect to smoke in an 8 day period.
Informed Consent: Prior to consenting smokers, research staff will visually inspect photo identification of smokers who report or appear to be under age 27. At the beginning of the first appointment, study personnel will explain the consent form and ask the smoker to read the form. Once the participant has finished reading the form, the study personnel member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form.
Randomization: After smokers have consented to participating in the study, study personnel will randomly assign them to a condition. The investigators will determine the randomization order a priori. Smokers have an equal chance of being randomized to receive one of four graphic warnings or one of four Surgeon General's warnings. They will receive the same warning on their packs during the study.
Assessment: Participants will complete 6 computer-based surveys during the study. The first appointment will take around 60 minutes and each subsequent visit will take around 30-45 minutes to complete. At their first visit, they will complete a "baseline pre-test," after which study personnel will show participants one of their cigarette packs with the assigned warning. Participants will be allowed to examine the pack. They will then return the pack to the study personnel and complete a "baseline post-test." At the next 3 appointments, participants will complete only one survey and their packs will be labeled. At the final appointment, they will only complete a survey.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years or older
- •Have smoked at least 100 cigarettes in his or her lifetime
- •Currently smoke cigarettes
- •Be able to read and speak English
排除标准
- •Pregnant women
- •Smokers who smoke exclusively roll-your-own cigarettes
- •Smokers concurrently enrolled in another cessation study
- •Smokers who smoke fewer than 7 cigarettes per week, on average
- •Smokers who live in the same household as someone who has enrolled in the study
结局指标
主要结局
Quit attempts
时间窗: Up to 4 weeks
The primary outcome is a quit attempt during the 4 weeks of the study, reported at either 1, 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.
次要结局
- Change in positive reinforcement attitudes(4 weeks)
- Change in negative reinforcement attitudes(4 weeks)
- Change in perceived likelihood(4 weeks)
- Change in forgoing a cigarette(4 weeks)
- Change in frequency of conversations about warning labels(4 weeks)
- Cognitive elaboration(4 weeks)
- Successful Quitting(4 weeks)
- Fear(4 weeks)
- Change in quit intentions(4 weeks)