NCT06663475尚未招募不适用
The Effectiveness of a Transtheoretical Model Based Health Education Intervention in Smoking Cessation Among Expectant Fathers: a Randomized Control Trial
Sun Yat-sen University0 个研究点目标入组 1,346 人开始时间: 2024年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,346
- 主要终点
- Biochemically validated smoking abstinence
研究概览
简要总结
This study aims to evaluate the effectiveness of the video-based health education in smoking cessation among expectant fathers by using two-arm randomized clinical trial to motivate this subgroup attempt to quit, quit smoking and maintain abstinence in the long term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male adult
- •has a pregnant partner
- •at least smoke 1 cigarette per day on average in the last month
- •be able to read or communicate in Chinese
排除标准
- •be or was participated in other smoking cessation program in the past year
- •mentally or physically unable to communicate with
- •can't play videos by electronic devices
- •the pregnant partner is a smoker
结局指标
主要结局
Biochemically validated smoking abstinence
时间窗: 12 month follow-up after randomization
Self-reported smoking abstinence will be biochemically validated by an exhaled carbon monoxide level \< 4 parts per million (p.p.m) and negative for salivary cotinine test.
次要结局
- Self-reported 7-day point prevalence quit rate(6, 12-month follow-up)
- Smoking Reduction(end of intervention; 3,6,12 month after randomization)
- Quit Attempt(end of intervention; 3,6,12 month after randomization)
- The change in transtheoretical model stages(end of intervention; 3,6,12 month after randomization)
- the Fagerstrom tolerance questionnaire(end of intervention; 3,6,12 month after randomization)
- Use of smoking cessation services(end of intervention; 3,6,12 month after randomization)
- Biochemically validated smoking abstinence(6 month follow-up)
研究者
Wei XIA, PhD
Principle Investigator
Sun Yat-sen University
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