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

Not Applicable

Completed

• Conditions: Tobacco Use Cessation; Smoking Cessation
• Interventions: Behavioral: Very brief advice; Behavioral: Brief AWARD advice; Drug: Nicotine replacement therapy sampling; Behavioral: Leaflet; Behavioral: Active referral

• Registration Number: NCT03671707
• Lead Sponsor: The University of Hong Kong

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2018-10-10
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1053

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Nicotine replacement therapy sampling	Brief AWARD advice + Nicotine replacement therapy sampling + Active referral
Control group	Very brief advice	Very brief advice (VBA) + Leaflet
Control group	Leaflet	Very brief advice (VBA) + Leaflet
Intervention group	Brief AWARD advice	Brief AWARD advice + Nicotine replacement therapy sampling + Active referral
Intervention group	Active referral	Brief AWARD advice + Nicotine replacement therapy sampling + Active referral

Primary Outcome Measures

Name	Time	Method
Biochemically-validated abstinence	6-month after baseline	Defined by an exhaled carbon monoxide level of \< 4 parts per million (ppm)

Secondary Outcome Measures

Name	Time	Method
Self-reported continuous abstinence in the past 24-week	6-month after baseline	Being completely smoke-free in the past 24-week
Use of nicotine replacement therapy	6-month after baseline	Any use of nicotine replacement therapy
Change in nicotine dependence	6-month after baseline	Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)
Smoking cessation service use	6-month after baseline	Any access to a smoking cessation service
Number of quit attempt	6-month after baseline	Defined by abstinence for at least 24 hours
Self-reported past 7-day abstinence	6-month after baseline	Being completely smoke-free in the past 7 days
Smoking reduction	6-month after baseline	Defined by at least 50% reduction in baseline daily number of cigarettes
Intention to quit	6-month after baseline	Defined by readiness to quit in 30 days

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong