Smoking Cessation, Tobacco Use Cessation
Conditions
Keywords
tobacco dependence treatment, combined brief intervention, AWARD advice, active referral, nicotine replacement therapy, pregnancy, family health, Chinese
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
Interventions
BEHAVIORALLeaflet
Subjects will receive a standard leaflet on perinatal smoking by Department of Health
BEHAVIORALBrief 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
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.
BEHAVIORALActive 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.
BEHAVIORALVery brief advice
Subjects will receive general advice to quit
Sponsors
Food and Health Bureau, Hong Kong
Queen Mary Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Kwong Wah Hospital
Queen Elizabeth Hospital, Hong Kong
United Christian Hospital
Princess Margaret Hospital, Hong Kong
Tuen Mun Hospital
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically-validated abstinence | 6-month after baseline | Defined by an exhaled carbon monoxide level of \< 4 parts per million (ppm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of nicotine replacement therapy | 3-month after baseline | Any use of nicotine replacement therapy |
| Self-reported past 7-day abstinence | 3-month after baseline | Being completely smoke-free in the past 7 days |
| Self-reported continuous abstinence in the past 24-week | 6-month after baseline | Being completely smoke-free in the past 24-week |
| Smoking cessation service use | 3-month after baseline | Any access to a smoking cessation service |
| Change in nicotine dependence | 3-month after baseline | Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence) |
| Number of quit attempt | 3-month after baseline | Defined by abstinence for at least 24 hours |
| Intention to quit | 3-month after baseline | Defined by readiness to quit in 30 days |
| Smoking reduction | 3-month after baseline | Defined by at least 50% reduction in baseline daily number of cigarettes |
Countries
Hong Kong
Outcome results
None listed