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Completed

NCT Number: NCT03671707

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

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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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The University of Hong Kong

Hong Kong

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for both expectant father and mother:

  • Hong Kong resident aged 18 or above
  • Able to read and communicate in Chinese
  • Living together in the past 7 days

Inclusion criteria

for expectant father:

  • Having smoked 1 or more cigarettes daily in the past 3 months
  • Having a telephone or mobile phone contact

Inclusion criteria

for expectant mother:

  • Not having smoked any cigarette in the past 30 days

Exclusion criteria

for expectant father

  • Having any history of severe angina, arrhythmia, or acute myocardial infarction
  • Having psychiatric/psychological diseases or regular psychotropic medications
  • Having used smoking cessation aids or participated in other smoking cessation services or projects in the past 3 months

Treatment and study plan

Brief AWARD advice

Behavioral

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

Nicotine replacement therapy sampling

Drug

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

Active referral

Behavioral

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

Behavioral

Subjects will receive general advice to quit

Other names: VBA

Leaflet

Behavioral

Subjects will receive a standard leaflet on perinatal smoking by Department of Health

Other names: Print-based material

Primary outcomes

  1. Biochemically-validated abstinence

    Time frame: 6-month after baseline

    Defined by an exhaled carbon monoxide level of < 4 parts per million (ppm)

Secondary outcomes

  1. Self-reported past 7-day abstinence

    Time frame: 3-month after baseline

    Being completely smoke-free in the past 7 days

  2. Self-reported past 7-day abstinence

    Time frame: 6-month after baseline

    Being completely smoke-free in the past 7 days

  3. Self-reported continuous abstinence in the past 24-week

    Time frame: 6-month after baseline

    Being completely smoke-free in the past 24-week

  4. Smoking reduction

    Time frame: 3-month after baseline

    Defined by at least 50% reduction in baseline daily number of cigarettes

  5. Smoking reduction

    Time frame: 6-month after baseline

    Defined by at least 50% reduction in baseline daily number of cigarettes

  6. Smoking cessation service use

    Time frame: 3-month after baseline

    Any access to a smoking cessation service

  7. Smoking cessation service use

    Time frame: 6-month after baseline

    Any access to a smoking cessation service

  8. Use of nicotine replacement therapy

    Time frame: 3-month after baseline

    Any use of nicotine replacement therapy

  9. Use of nicotine replacement therapy

    Time frame: 6-month after baseline

    Any use of nicotine replacement therapy

  10. Change in nicotine dependence

    Time frame: 3-month after baseline

    Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)

  11. Change in 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)

  12. Number of quit attempt

    Time frame: 3-month after baseline

    Defined by abstinence for at least 24 hours

  13. Number of quit attempt

    Time frame: 6-month after baseline

    Defined by abstinence for at least 24 hours

  14. Intention to quit

    Time frame: 3-month after baseline

    Defined by readiness to quit in 30 days

  15. Intention to quit

    Time frame: 6-month after baseline

    Defined by readiness to quit in 30 days

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • 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

Registry information

Official study 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

Acronym: BANSAR

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2018
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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