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临床试验/NCT03236025
NCT03236025已完成不适用

The Effectiveness of a Video-led Smoking Cessation Intervention in Helping Male Smokers in Mainland China Whose Partner Got Pregnant to Quit Smoking: A Randomized Control Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,023 人开始时间: 2017年7月1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
1,023
试验地点
1
主要终点
Biochemically validated smoking abstinence at the 6-month follow-up

研究概览

简要总结

This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of a video-led intervention in helping male smokers whose partner got pregnant in Mainland China to quit smoking.

详细描述

With a globally growing number of smokers, up to about half of men and one tenth of women are becoming smokers and relatively few stopping, especially in Mainland China.

It has been proved that tobacco is responsible for even more deaths and diseases. Smokers have two to three times mortality in middle age among otherwise similar persons who had never smoked. According to the literature review, smoking has been confirmed to be an important risk factor to most chronic diseases and cancer.

For the male smokers at their reproductive ages, who is preparing to have a baby, smoking may negatively influence their reproductive capacity. Sufficient studies found that the quantity and duration of smoking, especially the current smoking is positively associated with the risk of erectile dysfunction. Smoking may increase the risk of a higher risk of developing oligospermia, asthenozoospermia and teratozoospermia for man in the reproductive years, which may lead to the inefficiency of fertilization and even give birth to abnormal fetus. Besides, secondhand Smoking (SHS) exposure also have further and longer negative effects on their female partner and their baby born in the future. The non-smoking population is much more sensitive to the nicotine in the passive smoking than smokers. The SHS may increase the risk of respiratory infections, ear problem, immediate adverse effects on cardiovascular system, lung cancer and so on to adults. For the children, the passive smoking make children have a higher chance to get severe asthma, slow lung growth. Hence, children and women live with smokers may have a higher risk of premature death and disease. Besides, newborns whose mothers were exposed to secondhand smoke showed significantly lower scores in the habituation cluster and motor system cluster, as well as the delay of neurobehavioral development regardless of socio-demographic, obstetric and pediatric factors. Conclusively, smoking has direct and indirect negative effect to male smokers in reproductive ages themselves and their family members.

Based on the official statistic figures in 2010, about one third of people in China were current smokers, and the number of young smokers is increasing. While most current smokers (83.9%) report having no intention to quit smoking (WHO, 2011). On average, between 60% and 70% of Chinese men continue to smoke into middle age, which is different with the western countries. Hence, finding out a solution to decrease the married reproductive male smoking rate is extremely crucial.

Overall awareness of the health hazards of tobacco has improved in the last 15 years in China, but is still relatively poor. Even there were several patterns of propaganda and education applied in China, the efficiency is not very satisfactory. Hence, an effective education interventions that delivery the health hazards of tobacco to male smokers and secondhand smoking to their wives and baby born in the future should be developed and implemented for reproductive male smokers in China.

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

入选标准

  • male resident aged 18 or above;
  • smoking at least one cigarette per day averagely during the past 1 months and validated by exhaled CO test (≥ 4ppm);
  • have a pregnant partner whose embryo had been confirmed to not have any significant deformity;
  • able to communicate in Mandarin (including reading Chinese);
  • have a smart phone for intervention and follow-up

排除标准

  • smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study;
  • mentally or physically unfit for communication;

结局指标

主要结局

Biochemically validated smoking abstinence at the 6-month follow-up

时间窗: 6-month follow-up

The biochemically validated smoking abstinence was confirmed by an exhaled carbon monoxide level \< 4 parts per million (p.p.m.)

次要结局

  • The level of readiness to quit(6-month follow-up)
  • Self-reported 7-day point prevalence quit rate(6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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