A Combined Cessation Intervention of Brief Advice, Nicotine Replacement Therapy Sampling and Active Referral (BANSAR) for Smoking Fathers: a Multicenter, Single-blinded, Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,053
- 试验地点
- 1
- 主要终点
- Biochemically-validated abstinence
研究概览
简要总结
This study aims to evaluate the effects of a combined "cocktail", cessation intervention of brief advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers on smoking cessation outcomes
详细描述
Secondhand smoke (SHS) exposure cause substantial harms to pregnant women, foeti and infants. Smoking cessation (SC) interventions for smoking expectant fathers are needed particularly in China where male smoking predominates and many pregnant women (about 30% in Hong Kong) were exposed to SHS. Prenatal period presents a valuable teachable moment to engage smoking expectant father in tobacco dependence treatment. However, most smoking cessation trials were conducted in the Western countries on smoking pregnant women or smoking couples. Very few trials were designed to target fathers quitting.
Given the busy clinical settings in Hong Kong Public Hospitals, evidence-based, low-cost and sustainable brief cessation intervention applicable in real-world practice is imperative. Informed by previous research, a combined cessation intervention of brief advice, nicotine replacement therapy sampling and active referral (BANSAR) has been developed for smoking expectant father. This multicentre, pragmatic, assessor-blinded, individually-randomized controlled trial aims to evaluate BANSAR for smoking cessation outcomes in smoking expectant father visiting prenatal clinics 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
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Brief AWARD advice + Nicotine replacement therapy sampling + Active referral
干预措施: Brief AWARD advice (Behavioral)
Intervention group
Brief AWARD advice + Nicotine replacement therapy sampling + Active referral
干预措施: Nicotine replacement therapy sampling (Drug)
Intervention group
Brief AWARD advice + Nicotine replacement therapy sampling + Active referral
干预措施: Active referral (Behavioral)
Control group
Very brief advice (VBA) + Leaflet
干预措施: Very brief advice (Behavioral)
Control group
Very brief advice (VBA) + Leaflet
干预措施: Leaflet (Behavioral)
结局指标
主要结局
Biochemically-validated abstinence
时间窗: 6-month after baseline
Defined by an exhaled carbon monoxide level of \< 4 parts per million (ppm)
次要结局
- Self-reported continuous abstinence in the past 24-week(6-month after baseline)
- Use of nicotine replacement therapy(6-month after baseline)
- Change in nicotine dependence(6-month after baseline)
- Smoking cessation service use(6-month after baseline)
- Number of quit attempt(6-month after baseline)
- Self-reported past 7-day abstinence(6-month after baseline)
- Smoking reduction(6-month after baseline)
- Intention to quit(6-month after baseline)
研究者
Dr. Wang Man-Ping
Assistant Professor
The University of Hong Kong
