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临床试验/NCT03671707
NCT03671707已完成不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,053 人开始时间: 2018年10月10日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention group

Experimental

Brief AWARD advice + Nicotine replacement therapy sampling + Active referral

干预措施: Brief AWARD advice (Behavioral)

Intervention group

Experimental

Brief AWARD advice + Nicotine replacement therapy sampling + Active referral

干预措施: Nicotine replacement therapy sampling (Drug)

Intervention group

Experimental

Brief AWARD advice + Nicotine replacement therapy sampling + Active referral

干预措施: Active referral (Behavioral)

Control group

Active Comparator

Very brief advice (VBA) + Leaflet

干预措施: Very brief advice (Behavioral)

Control group

Active Comparator

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

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

Dr. Wang Man-Ping

Assistant Professor

The University of Hong Kong

研究点 (1)

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