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

Smoking Cessation Clinical Trial

— BANSAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671707
• Other study ID #: 15162691
• Secondary ID: HKUCTR-2422
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Cessation

Intervention

Behavioral:
• Brief AWARD advice
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

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.
• Very brief advice
Subjects will receive general advice to quit
• Leaflet
Subjects will receive a standard leaflet on perinatal smoking by Department of Health

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The University of Hong Kong	Hong Kong

Sponsors (9)

Lead Sponsor	Collaborator
The University of Hong Kong	Food and Health Bureau, Hong Kong, Kwong Wah Hospital, Pamela Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong, Tuen Mun Hospital, United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically-validated abstinence	Defined by an exhaled carbon monoxide level of < 4 parts per million (ppm)	6-month after baseline
Secondary	Self-reported past 7-day abstinence	Being completely smoke-free in the past 7 days	3-month after baseline
Secondary	Self-reported past 7-day abstinence	Being completely smoke-free in the past 7 days	6-month after baseline
Secondary	Self-reported continuous abstinence in the past 24-week	Being completely smoke-free in the past 24-week	6-month after baseline
Secondary	Smoking reduction	Defined by at least 50% reduction in baseline daily number of cigarettes	3-month after baseline
Secondary	Smoking reduction	Defined by at least 50% reduction in baseline daily number of cigarettes	6-month after baseline
Secondary	Smoking cessation service use	Any access to a smoking cessation service	3-month after baseline
Secondary	Smoking cessation service use	Any access to a smoking cessation service	6-month after baseline
Secondary	Use of nicotine replacement therapy	Any use of nicotine replacement therapy	3-month after baseline
Secondary	Use of nicotine replacement therapy	Any use of nicotine replacement therapy	6-month after baseline
Secondary	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
Secondary	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
Secondary	Number of quit attempt	Defined by abstinence for at least 24 hours	3-month after baseline
Secondary	Number of quit attempt	Defined by abstinence for at least 24 hours	6-month after baseline
Secondary	Intention to quit	Defined by readiness to quit in 30 days	3-month after baseline
Secondary	Intention to quit	Defined by readiness to quit in 30 days	6-month after baseline