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临床试验/NCT04875546
NCT04875546Unknown不适用

An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Structured questionnaire

研究概览

简要总结

Current smoking cessation interventions are focused only on smoking behaviors, and drinking habits are generally overlooked. The aims of the project is to examine the feasibility of implementing an integrated smoking cessation and alcohol abstinence intervention in young Hong Kong Chinese smokers.

详细描述

The study is a three-arm randomized controlled trial. (1)The standard treatment group , participants will receive a brief smoking cessation intervention based on the '5A' and '5R' model, then the RA will assist the participants to quit smoking using the STAR method. (2) For the alcohol intervention group, participants will also receive a brief smoking cessation intervention with the models as the ST group. After that they will receive a brief advice on alcohol use based on the FRAMES model. Then the RA will invite participants to complete the Alcohol Use Disorders Identification Test(AUDIT). (3) For the Control group, participants will be provide with two leaflets, one for smoking cessation and another for alcohol abstinence. All the data collection will be conducted at baseline, 1 week, 1 month , 3 months and 6 months for follow up.

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

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • smoked at least one cigarette in the past 30 days.
  • have consumed at least one cup of alcohol in the past 30 days.
  • speak Cantonese

排除标准

  • have a compromised mental status and/or communication problems.
  • participating in other smoking cessation interventions

结局指标

主要结局

Structured questionnaire

时间窗: At baseline

The questionnaire will include six areas: smoking profile, cessation history, readiness to quit, self-efficacy to quit, alcohol use and demographics.

The biochemical validation

时间窗: At the 6-month follow-up

Measuring the level of carbon monoxide in expired air and level of cotinine in saliva

次要结局

  • Retention rate at baseline(At baseline)
  • Retention rate at 1-month follow-up(At 1-month follow-up)
  • Adherence to intervention at baseline(At baseline)
  • Adherence to intervention at 1-week follow-up(At 1-week follow-up)
  • Adherence to intervention at 1-month follow-up(At 1-month follow-up)
  • Retention rate at 3-month follow-up(At 3-month follow-up)
  • Completion rate at 1-month follow-up(At 1-month follow-up)
  • Eligibility rate(Immediately after the training workshop)
  • Retention rate at 1-week follow-up(At 1-week follow-up)
  • Completion rate at 3-month follow-up(At 3-month follow-up)
  • Missing data at 1-month follow-up(At 1-month follow-up)
  • Missing data at 3-month follow-up(At 3-month follow-up)
  • Missing data at 6-month follow-up(At 6-month follow-up)
  • Randomization rate(Immediately after the training workshop)
  • Completion rate at 6-month follow-up(At 6-month follow-up)
  • Adverse events(At the 6 months follow up)
  • Consent rate(Immediately after the training workshop)
  • Attendance rate(Immediately after the training workshop)
  • Adherence to intervention at 3-month follow-up(At 3-month follow-up)
  • Adherence to intervention at 6-month follow-up(At 6-month follow-up)
  • Completion rate at 1-week follow-up(At 1-week follow-up)
  • Screen rate(Immediately after the training workshop)
  • Retention rate at 6 month follow-up(At 6-month follow-up)
  • Completion rate at baseline(At baseline)
  • Missing data at baseline(At baseline)
  • Missing data at 1-week follow-up(At 1-week follow-up)

研究者

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

Dr Eva Ho

Assistant Professor

The Hong Kong Polytechnic University

研究点 (2)

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