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临床试验/NCT06413797
NCT06413797已完成不适用

Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use

UNC Lineberger Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 928 人开始时间: 2024年7月18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
928
试验地点
2
主要终点
Willingness to Use Little Cigars Cigarillos (LCCs)

研究概览

简要总结

This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.

详细描述

Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.

Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.

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
15 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants)
  • Agree to provide their honest answers
  • Susceptible to using LCCs, or have ever used little cigars and/or cigarillos, or currently use little cigar and/or cigarillos in the past 30 days
  • Age 15 - 20 years old
  • Currently living in US or US territory
  • Able to complete 2 surveys that take approximately 15 minutes
  • Able to complete a 2-minute survey each day for 6 days
  • Able to verify they are not a bot using CAPTCHA
  • Able to answer a simple, random math question

排除标准

  • Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA).
  • Not able to answer a simple, random math question.

结局指标

主要结局

Willingness to Use Little Cigars Cigarillos (LCCs)

时间窗: Day 8

The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.

次要结局

  • Past 7 Days Little Cigar Use(Day 8)
  • Past 7 Days Cigarillo Use(Day 8)
  • Little Cigar and Cigarillos (LCCs) Susceptibility(Day 8)
  • Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use(Day 8)
  • Warning Negative Affect/Worry(Day 7)
  • Knowledge of Little Cigar and Cigarillo (LCC) Harms(Day 8)
  • Beliefs About Little Cigar and Cigarillo (LCC) Harms(Day 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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