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临床试验/NCT03446170
NCT03446170已完成不适用

Examining the Impact of Cigarette Package Warnings and Packaging Regulations Among Young Adult Smokers

Georgetown University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Motivation to quit smoking

研究概览

简要总结

The objective of this study is to examine whether cigarette packaging regulations including graphic health warning labels on cigarette packs and requiring plain, unbranded packaging reduce the appeal of cigarettes and prompt young adult smokers to quit.

详细描述

The study includes young adult smokers ages 18 to 30. Eligible participants are young adults ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now smoking on all or some days. Participants must also reside in the metro Washington, DC area. The first portion of the study is a within-subjects experiment simulating point of sale cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized unbranded) packaging. In the second portion of the study, the same participants take part in a prospective experiment to determine the impact of graphic cigarette warning message framing (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in place of their regular packs for 4 weeks, or to a control condition which will continue to use their regular packs. All participants complete baseline and follow-up assessments and respond to daily mobile phone text message prompts on their personal mobile phones during the 4 week exposure period. Participants complete follow-up assessments capturing motivation to quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and 1- and 3-months later.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

盲法说明

The study tests the effects of graphic cigarette warning labels and packaging regulations, therefore it is unmasked.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 to 30 years
  • Smoke at least 100 cigarettes in their lifetime
  • Now smoke cigarettes on all or some days
  • Reside in the Washington, DC metro area
  • Willing to send and receive text messages on a personal mobile phone

排除标准

  • No additional exclusion criteria

结局指标

主要结局

Motivation to quit smoking

时间窗: At the conclusion of the 4 week exposure

Motivation to quit smoking is measured using a valid scale comprised of 4 questions. Participants report how likely it is they will quit smoking completely, reduce the number of cigarettes they smoke, and talk to a friend, family member, or spouse/partner about quitting smoking. Participants respond using options for definitely will not, probably will not, probably will, or definitely will for each question.

Cigarette purchase appeal

时间窗: Baseline

The effects of graphic cigarette warnings and plain packaging on cigarette purchase appeal will be measured using data collected from a within-subjects experiment at baseline. Participants are randomly assigned to compare each pair of packs from the experimental conditions versus a standard branded control pack. For each pair, cigarette purchase appeal is measured with 5 valid questions assessing: 1) Which pack would you be most likely to buy? 2) Which pack is the most appealing? 3) Which pack attracts your attention? 4) Which pack contains cigarettes that are the most harmful to your health? 5) Which pack makes you think about the health risks of smoking?

次要结局

  • Smoking quit attempts(At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure)
  • Motivation to quit cigarette smoking.(At 1-month and 3-months post-exposure)
  • Cigarette smoking behavior(At the conclusion of the 4 week exposure, and at 1- and 3-months post-exposure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Darren Mays

Assistant Professor

Georgetown University

研究点 (2)

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