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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1053 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2020-12-31

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

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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

Conditions

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Smoking Cessation Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Brief AWARD advice + Nicotine replacement therapy sampling + Active referral

Group Type EXPERIMENTAL

Brief AWARD advice

Intervention Type BEHAVIORAL

Subject will receive brief, face-to-face counselling following a structured AWARD model at baseline :

1. Ask: smokers will be asked about their smoking behaviour
2. 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.
3. Advise to quit or reduce their smoking and use the provided 1-week nicotine replace therapy sample as soon as possible
4. Refer smokers to smoking cessation services if they agree.
5. Do-it-again: repeat the AWARD advise through telephone boosters at 2-week and 4-week after baseline

Nicotine replacement therapy sampling

Intervention Type DRUG

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.

Active referral

Intervention Type BEHAVIORAL

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.

Control group

Very brief advice (VBA) + Leaflet

Group Type ACTIVE_COMPARATOR

Very brief advice

Intervention Type BEHAVIORAL

Subjects will receive general advice to quit

Leaflet

Intervention Type BEHAVIORAL

Subjects will receive a standard leaflet on perinatal smoking by Department of Health

Interventions

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Brief AWARD advice

Subject will receive brief, face-to-face counselling following a structured AWARD model at baseline :

1. Ask: smokers will be asked about their smoking behaviour
2. 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.
3. Advise to quit or reduce their smoking and use the provided 1-week nicotine replace therapy sample as soon as possible
4. Refer smokers to smoking cessation services if they agree.
5. Do-it-again: repeat the AWARD advise through telephone boosters at 2-week and 4-week after baseline

Intervention Type BEHAVIORAL

Nicotine replacement therapy sampling

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.

Intervention Type DRUG

Active referral

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.

Intervention Type BEHAVIORAL

Very brief advice

Subjects will receive general advice to quit

Intervention Type BEHAVIORAL

Leaflet

Subjects will receive a standard leaflet on perinatal smoking by Department of Health

Intervention Type BEHAVIORAL

Other Intervention Names

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Ask, Warn, Advise, Refer and Do-it-again NRT sample VBA Print-based material

Eligibility Criteria

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Inclusion Criteria

1. Hong Kong resident aged 18 or above
2. Able to read and communicate in Chinese
3. Living together in the past 7 days

1. Having smoked 1 or more cigarettes daily in the past 3 months
2. Having a telephone or mobile phone contact

1\. Not having smoked any cigarette in the past 30 days

Exclusion Criteria

1. Having any history of severe angina, arrhythmia, or acute myocardial infarction
2. Having psychiatric/psychological diseases or regular psychotropic medications
3. Having used smoking cessation aids or participated in other smoking cessation services or projects in the past 3 months

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes