An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- consent rate
研究概览
简要总结
The specific objectives of this study are to investigate the (1) feasibility, (2) preliminary effectiveness and (3) effect sizes of the integrated smoking cessation and alcohol intervention when compared to standalone smoking cessation (ST) and control among young adults in Hong Kong.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •aged 18 to 25 years
- •smoked at least one traditional cigarette in the past 30 days
- •consumed at least one alcohol unit (one "alcohol unit" contains 10g of pure 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 and/or alcohol interventions
研究组 & 干预措施
Standard treatment (ST) arm
Participants will receive a brief smoking cessation intervention based on the "5A" and "5R" models proposed by the World Health Organization. The "STAR" method as quitting skills will also be provided. The "5A" model includes five steps to identify participants who are ready to quit smoking. For those who are ready to quit, a research assistant will assist them to quit using the "STAR" method: Set a quit date within 1 week, Tell the surrounding people that they have planned to quit and solicited their support, Anticipate challenges to quit attempt, and Remove all tobacco products. Otherwise, the "5R" model will be applied to those not yet ready to quit. After "5R" is applied, the research assistant will repeat the assessment of their willingness to quit. The booster interventions will be delivered by the research assistant through follow-ups arranged with the participants via phone.
干预措施: Standard treatment (ST) arm (Behavioral)
Integrated Intervention (II) arm
In addition to the brief smoking cessation intervention based on the "5A" and "5R" models, participants in this arm received brief advice on alcohol use based on the "FRAMES" model. The booster interventions will be delivered by the research assistant through follow-ups arranged with the participants via phone.
干预措施: Integrated Intervention (II) arm (Behavioral)
Control arm
Participants will be provided with two leaflets designed by Department of health: one for smoking cessation and another for alcohol abstinence.
结局指标
主要结局
consent rate
时间窗: From screening to the end of treatment after 6 months
the number of eligible smokers who agree to participate divided by the number of eligible smokers
screening rate
时间窗: From screening to the end of treatment after 6 months
the number of smokers screened divided by the number of smokers available for screening
eligibility rate
时间窗: From screening to the end of treatment after 6 months
the number of eligible smokers divided by the number of screened people
randomization rate
时间窗: From screening to the end of treatment after 6 months
the number of participants who are randomized divided by the number of eligible smokers who consent to participate
attendance rate
时间窗: From screening to the end of treatment after 6 months
the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms (ST and II)
adherence to intervention
时间窗: From screening to the end of treatment after 6 months
the number of participants in the two treatment arms who practice the skills learned during the intervention divided by the number of participants in the two treatment arms
retention rate
时间窗: From screening to the end of treatment after 6 months
the number of participants who remain in the study divided by the number of participants randomized
completion rate
时间窗: From screening to the end of treatment after 6 months
the number of participants who complete the questionnaire divided by the number of questionnaires distributed
missing data
时间窗: From screening to the end of treatment after 6 months
the percentage of missing data
adverse events
时间窗: From screening to the end of treatment after 6 months
unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline
次要结局
- Smoking quit rate(From screening to the end of treatment after 6 months)
- alcohol quit rate(From screening to the end of treatment after 6 months)
研究者
Dr Eva Ho
associate professor
The Hong Kong Polytechnic University