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临床试验/NCT04252014
NCT04252014已完成不适用

Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use

Georgetown University1 个研究点 分布在 1 个国家目标入组 830 人开始时间: 2020年2月4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
830
试验地点
1
主要终点
Hookah Tobacco Initiation

研究概览

简要总结

This is a 2-arm randomized controlled trial to test the effects of hookah tobacco public education messages among young adults who are susceptible non-users of hookah tobacco and those who are current hookah tobacco users. The primary outcomes are hookah tobacco use behavior (initiation among baseline susceptible non-users, frequency of use and cessation among baseline current users) at 6-month follow-up. Secondary outcomes are curiosity to use hookah tobacco (susceptible non-users) and motivation to quit using hookah tobacco (current hookah users) measured at 6-month follow-up. These outcomes will also be measured at 2- and 4-month follow-up time points.

详细描述

This is a 2-arm randomized controlled trial to test the effects of hookah tobacco public education messages among young adults who are susceptible non-users of hookah tobacco and current hookah tobacco users. Primary outcomes of hookah use behavior will be measured at the 6-month follow-up assessment. Secondary outcomes include curiosity to use hookah tobacco among susceptible non-users and motivation to quit using hookah tobacco among current users. All outcomes are also assessed at 2- and 4-month follow-up time points. All trial participants will be recruited from a US national consumer research panel. Eligible participants will be 1) young adults ages 18 to 30 (inclusive); 2) who have never used hookah tobacco but are deemed susceptible or report hookah tobacco use at least once within the past month; and 3) are enrolled members of the partnering consumer research panel. Panel members will be contacted via email with a brief description of the study and a link to an eligibility screener and online informed consent form. Eligible participants will complete a secure online baseline assessment of demographic characteristics, tobacco use history, and measures of hookah tobacco use behavior, beliefs, attitudes, and perceptions. After completing a baseline, participants will be randomly assigned in approximately equal numbers to one of two arms: 1) hookah tobacco messaging arm; 2) control arm. Through 4 brief study communications delivered approximately weekly, participants will receive study messages to which they are randomized and will complete brief self-report measures online on their responses to the messages. For the hookah tobacco messaging arm, communications will consist of study messages conveying risks of hookah tobacco use with random assignment of the order of messages with each exposure. In response to each message, participants will complete measures of message response and hookah-related beliefs, attitudes, and perceptions. Participants in the control condition will receive study communications with brief messages about health behaviors unrelated to tobacco (e.g., sun protection) and will complete the same measures. Hookah tobacco use behaviors, intentions and curiosity to use hookah tobacco (non-users), motivation to quit (current users), and hypothesized mediators will be assessed 2-, 4-, and 6-months after the message exposure period with the primary outcomes captured at 6-month follow-up.

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 30 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18 to 30
  • •Smoked hookah tobacco within the past 30 days, OR never smoked hookah tobacco and deemed susceptible to using hookah tobacco based on answers to screening questions
  • •Member of partnering consumer research panel conducting the study

排除标准

  • •Age less than 18 or greater than 30
  • •Has not smoked hookah tobacco in the past 30 days OR has never smoked hookah tobacco and is not susceptible
  • •Not a member of partnering consumer research panel conducting the study

研究组 & 干预措施

Non-Tobacco Messages

No Intervention

Participants in the control group will receive messages about health topics unrelated to tobacco use (e.g., sun safety). Messages will be delivered online through 4 brief study communications.

Hookah Tobacco Messages

Experimental

Participants in the hookah tobacco messaging group will receive hookah tobacco public education messages delivered online through 4 brief study communications. Messages will communicate about the risks of hookah tobacco use in the following theme areas: 1) Health Harms; 2) Addictiveness; 3) Social Use; 4) Flavorings. The order of message themes delivered in each study communication will be randomized.

干预措施: Hookah tobacco messages (Behavioral)

结局指标

主要结局

Hookah Tobacco Initiation

时间窗: 6 months

Hookah tobacco initiation among those who are susceptible non-users at baseline will be measured using a single valid survey question asking if participants have ever used hookah tobacco, even one or two puffs, at follow-up. The question asks if participants have ever smoked hookah tobacco based on a yes/no response. No hookah tobacco initiation is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have initiated hookah tobacco at the 6 month follow-up.

Hookah Tobacco Use Frequency

时间窗: 6 months

Hookah tobacco use frequency will be measured in baseline current hookah users with a single valid question asking on how many days they smoked hookah tobacco in the past 30 days. Baseline current hookah users who reported they quit were coded as smoking 0 of the past 30 days. Less frequent hookah use is considered a better outcome.

Hookah Tobacco Cessation

时间窗: 6 months

Hookah tobacco cessation is measured using a single valid question adapted from the national Population Assessment of Tobacco and Health (PATH) survey asking participants who report they have not smoked hookah tobacco if they have stopped smoking hookah tobacco completely. The item asks if participants have completely stopped smoking hookah tobacco based on a yes/no response. Quitting hookah tobacco use (i.e., a response of "yes") is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have stopped smoking hookah tobacco completely at the 6 month follow-up.

次要结局

  • Hookah Tobacco Curiosity(6 months)
  • Motivation to Quit Smoking Hookah Tobacco(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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