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临床试验/NCT06818786
NCT06818786已完成不适用

Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors: A Randomized Controlled Trial

Georgia State University1 个研究点 分布在 1 个国家目标入组 1,010 人开始时间: 2024年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,010
试验地点
1
主要终点
Emotional and cognitive responses

研究概览

简要总结

This proposed study will assess the effects of different scenarios of PHW policies on smokers' reactions to warnings, attitudes and beliefs, behavioral intentions, and quitting behaviors, with specific aims: 1) to assess the impact of new PHWs covering 50% of cigarette packs, 2) to assess the impact of new larger PHWs covering 85% of cigarette packs, 3) to assess the impact of incorporating quitline information on cigarette packs, and 4) to assess the impact of plain packaging. These aims will be achieved by conducting a five-arm RCT among 1000 adult smokers (n=200 per arm). It includes four intervention groups: 1) branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information, 2) branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information, 3) branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information, and 4) plain pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information. A control group will use branded packs with the current set of 6 PHWs, covering 50% of cigarette packs without quitline information.

Given that the pictorial health warnings (PHW) on cigarette packs need to be renewed, this project will provide highly policy-relevant and timely scientific evidence on the effect of new PHW policies in Vietnam. Additionally, this project would be the first to address the research gap in understanding the effect of adding quitline information to PHWs-a gap not explored in previous studies. With the potential for significant outcomes, the findings will help Vietnamese policymakers enact stronger PHW policies in upcoming years, aiming to increase perceived harms of smoking and foster smoking cessation, ultimately saving millions of lives in Vietnam

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
否

入选标准

  • •having smoked at least 100 cigarettes in their lifetime and currently smoking
  • •aged 18 or older
  • •fluent in Vietnamese
  • •smartphone users

排除标准

  • 未提供

研究组 & 干预措施

Branded pack with the current set of PHWs covering 50% of the pack without quitline information

Active Comparator

干预措施: Branded pack with the current set of PHWs covering 50% of the pack without quitline information (Other)

Branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information

Experimental

干预措施: Branded pack with new PHWs covering 50% of the pack without quitline information (Other)

Plain pack with new PHWs covering 85% of the pack with quitline information

Experimental

干预措施: Plain pack with new PHWs covering 85% of the pack with quitline information (Other)

Branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information

Experimental

干预措施: Branded pack with new PHWs covering 85% of the pack with quitline information (Other)

Branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information

Experimental

干预措施: Branded pack with new PHWs covering 85% of the pack without quitline information (Other)

结局指标

主要结局

Emotional and cognitive responses

时间窗: At the enrollment

Negative emotions, including sadness, anger, fear, guilt, disgust, worry, and shame, were measured on a scale from 1 (not at all) to 9 (extremely). Perceived message effectiveness was assessed using the following statements: "This warning discourages me from wanting to smoke." "This warning makes smoking seem unpleasant to me." "This warning makes me concerned about the health effects of smoking." Participants rated their agreement on a scale from 1 (strongly disagree) to 7 (strongly agree), with an additional "don't know" option.

次要结局

  • Attitudes and beliefs(At the enrollment)
  • Behavioral intentions(At the enrollment)
  • Recall and behavioral outcomes at 2-week follow-up(at 2 weeks)

研究者

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

Thi Phuong Thao Tran

Principal Investigator

Georgia State University

研究点 (1)

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