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

The University of Hong Kong1,053 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,053

Conditions

Smoking Cessation Tobacco Use Cessation

Interventions

Brief AWARD adviceBEHAVIORAL

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 samplingDRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria for both expectant father and mother: 1. Hong Kong resident aged 18 or above 2. Able to read and communicate in Chinese 3. Living together in the past 7 days Inclusion criteria for expectant father: 1. Having smoked 1 or more cigarettes daily in the past 3 months 2. 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 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

Locations (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Biochemically-validated abstinence

Defined by an exhaled carbon monoxide level of \< 4 parts per million (ppm)

Time frame: 6-month after baseline

Secondary Outcomes

Self-reported past 7-day abstinence

Being completely smoke-free in the past 7 days

Time frame: 3-month after baseline

Self-reported past 7-day abstinence

Being completely smoke-free in the past 7 days

Time frame: 6-month after baseline

Self-reported continuous abstinence in the past 24-week

Being completely smoke-free in the past 24-week

Time frame: 6-month after baseline

Smoking reduction

Defined by at least 50% reduction in baseline daily number of cigarettes

Time frame: 3-month after baseline

Smoking reduction

Defined by at least 50% reduction in baseline daily number of cigarettes

Time frame: 6-month after baseline

Smoking cessation service use

Any access to a smoking cessation service

Time frame: 3-month after baseline

Smoking cessation service use

Any access to a smoking cessation service

Time frame: 6-month after baseline

Use of nicotine replacement therapy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.