School of Nursing, The University of Hong Kong
Hong Kong
NCT Number: NCT03671707
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
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Notify Me18 year and older
Male
Interventional
Not applicable
Hong Kong
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for both expectant father and mother:
Inclusion criteria
for expectant father:
Inclusion criteria
for expectant mother:
Exclusion criteria
for expectant father
Subject will receive brief, face-to-face counselling following a structured AWARD model at baseline :
Other names: Ask, Warn, Advise, Refer and Do-it-again
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
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.
Subjects will receive general advice to quit
Other names: VBA
Subjects will receive a standard leaflet on perinatal smoking by Department of Health
Other names: Print-based material
Time frame: 6-month after baseline
Defined by an exhaled carbon monoxide level of < 4 parts per million (ppm)
Time frame: 3-month after baseline
Being completely smoke-free in the past 7 days
Time frame: 6-month after baseline
Being completely smoke-free in the past 7 days
Time frame: 6-month after baseline
Being completely smoke-free in the past 24-week
Time frame: 3-month after baseline
Defined by at least 50% reduction in baseline daily number of cigarettes
Time frame: 6-month after baseline
Defined by at least 50% reduction in baseline daily number of cigarettes
Time frame: 3-month after baseline
Any access to a smoking cessation service
Time frame: 6-month after baseline
Any access to a smoking cessation service
Time frame: 3-month after baseline
Any use of nicotine replacement therapy
Time frame: 6-month after baseline
Any use of nicotine replacement therapy
Time frame: 3-month after baseline
Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)
Time frame: 6-month after baseline
Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)
Time frame: 3-month after baseline
Defined by abstinence for at least 24 hours
Time frame: 6-month after baseline
Defined by abstinence for at least 24 hours
Time frame: 3-month after baseline
Defined by readiness to quit in 30 days
Time frame: 6-month after baseline
Defined by readiness to quit in 30 days
The University of Hong Kong
Other
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
Acronym: BANSAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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