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

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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Brief AWARD advice; Drug: Nicotine replacement therapy sampling; Behavioral: Active referral; Behavioral: Very brief advice; Behavioral: Leaflet

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

• Study Type: Interventional
• Enrollment (Actual): 1053
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of Nursing, The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Brief AWARD advice + Nicotine replacement therapy sampling + Active referral	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; Other Names: Ask, Warn, Advise, Refer and Do-it-again; 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.; Other Names: NRT sample; 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.
Active Comparator: Control group; Very brief advice (VBA) + Leaflet	Behavioral: Very brief advice; Subjects will receive general advice to quit; Other Names: VBA; Behavioral: Leaflet; Subjects will receive a standard leaflet on perinatal smoking by Department of Health; Other Names: Print-based material

What is the study measuring?

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	6-month after baseline
Number of quit attempt	Defined by abstinence for at least 24 hours	6-month after baseline
Smoking cessation service use	Any access to a smoking cessation service	6-month after baseline
Self-reported past 7-day abstinence	Being completely smoke-free in the past 7 days	3-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
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Luk TT, Lam TH, Leung WC, Leung KY, Cheung KW, Kwa C, Siong KH, Tang KK, Lee KW, Hsieh CJ, Wu YS, Li WH, Wang MP. Brief Advice, Nicotine Replacement Therapy Sampling, and Active Referral for Expectant Fathers Who Smoke Cigarettes: A Randomized Clinical Trial. JAMA Intern Med. 2021 Aug 1;181(8):1081-1089. doi: 10.1001/jamainternmed.2021.2757.
• Luk TT, Hsieh CJ, Leung WC, Leung KY, Cheung KW, Kwa C, Siong KH, Tang KK, Lee KW, Li WH, Lam TH, Wang MP. Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial. Contemp Clin Trials. 2020 Jun;93:106006. doi: 10.1016/j.cct.2020.106006. Epub 2020 Apr 19.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Chinese; pregnancy; nicotine replacement therapy; tobacco dependence treatment; combined brief intervention; AWARD advice; active referral; family health
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 15162691; HKUCTR-2422 (Registry Identifier: HKU Clinical Trials Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No