Brief Advice, Nicotine Replacement Therapy Sampling and Active Referral (BANSAR) for Smoking Fathers

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Smoking Cessation, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Brief AWARD advice
* Drug: Nicotine replacement therapy sampling
* Behavioral: Active referral
* Behavioral: Very brief advice
* Behavioral: Leaflet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for both expectant father and mother: Hong Kong resident aged 18 or above Able to read and communicate in Chinese Living together in the past 7 days Inclusion criteria for expectant father: Having smoked 1 or more cigarettes daily in the past 3 months Having a telephone or mobile phone contact Inclusion criteria for expectant mother: 1. Not having smoked any cigarette in the past 30 days Exclusion Criteria for expectant father Having any history of severe angina, arrhythmia, or acute myocardial infarction Having psychiatric/psychological diseases or regular psychotropic medications Having used smoking cessation aids or participated in other smoking cessation services or projects in the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Brief AWARD advice + Nicotine replacement therapy sampling + Active referral | Behavioral: Brief AWARD advice<br>* Subject will receive brief, face-to-face counselling following a structured AWARD model at baseline : Ask: smokers will be asked about their smoking behaviour Warn about the harms of smoking using a leaflet which contain information about harms of secondhand smoke to women, fetus and infant, motivational messages to quit and smoking cessation services. Advise to quit or reduce their smoking and use the provided 1-week nicotine replace therapy sample as soon as possible Refer smokers to smoking cessation services if they agree. Do-it-again: repeat the AWARD advise through telephone boosters at 2-week and 4-week after baseline<br>* Other names: Ask, Warn, Advise, Refer and Do-it-again;Drug: Nicotine replacement therapy sampling<br>* Subjects will receive 1-week supply of free nicotine patch or gum with dosage based on participants' number of cigarette per day. An information card containing reminders of nicotine replacement therapy use and actions to handle potential side effects will be provided.<br>* Other names: NRT sample;Behavioral: Active referral<br>* Subjects will be encouraged to select and access a smoking cessation services in Hong Kong. If the subjects agree, their contact information will be sent to the smoking cessation service providers for further arrangement.<br>|
| Active Comparator: Control group<br>Very brief advice (VBA) + Leaflet | Behavioral: Very brief advice<br>* Subjects will receive general advice to quit<br>* Other names: VBA;Behavioral: Leaflet<br>* Subjects will receive a standard leaflet on perinatal smoking by Department of Health<br>* Other names: Print-based material;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically-validated abstinence | Defined by an exhaled carbon monoxide level of < 4 parts per million (ppm) | 6-month after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported past 7-day abstinence | Being completely smoke-free in the past 7 days | 3-month after baseline | 
| Self-reported past 7-day abstinence | Being completely smoke-free in the past 7 days | 6-month after baseline | 
| Self-reported continuous abstinence in the past 24-week | Being completely smoke-free in the past 24-week | 6-month after baseline | 
| Smoking reduction | Defined by at least 50% reduction in baseline daily number of cigarettes | 3-month after baseline | 
| Smoking reduction | Defined by at least 50% reduction in baseline daily number of cigarettes | 6-month after baseline | 
| Smoking cessation service use | Any access to a smoking cessation service | 3-month after baseline | 
| Smoking cessation service use | Any access to a smoking cessation service | 6-month after baseline | 
| Use of nicotine replacement therapy | Any use of nicotine replacement therapy | 3-month after baseline | 
| Use of nicotine replacement therapy | Any use of nicotine replacement therapy | 6-month after baseline | 
| Change in nicotine dependence | Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence) | 3-month after baseline | 
| Change in nicotine dependence | Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence) | 6-month after baseline | 
| Number of quit attempt | Defined by abstinence for at least 24 hours | 3-month after baseline | 
| Number of quit attempt | Defined by abstinence for at least 24 hours | 6-month after baseline | 
| Intention to quit | Defined by readiness to quit in 30 days | 3-month after baseline | 
| Intention to quit | Defined by readiness to quit in 30 days | 6-month after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco dependence treatment, combined brief intervention, AWARD advice, active referral, nicotine replacement therapy, pregnancy, family health, Chinese