NCT03671707

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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

• Smoking Cessation
• Tobacco Use Cessation

Interventions

Type	Name	Description
BEHAVIORAL	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
DRUG	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.
BEHAVIORAL	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.
BEHAVIORAL	Very brief advice	Subjects will receive general advice to quit
BEHAVIORAL	Leaflet	Subjects will receive a standard leaflet on perinatal smoking by Department of Health

Timeline

• Start date: 2018-10-10
• Primary completion: 2020-10-31
• Completion: 2020-12-31
• First posted: 2018-09-14
• Last updated: 2021-08-17

Locations

1 site across 1 country: Hong Kong