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Smoking CessationBANSARNCT03671707

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

A study testing Brief AWARD advice, Nicotine replacement therapy sampling and Active referral in people with Smoking Cessation and Tobacco Use Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Tobacco Use Cessation
What is being tested?
Brief AWARD advice, Nicotine replacement therapy sampling and Active referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,053 participants
Where
1 siteHong Kong
Study dates
10 Oct 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Hong Kong resident aged 18 or above
  • Able to read and communicate in Chinese
  • Living together in the past 7 days
  • Having smoked 1 or more cigarettes daily in the past 3 months
  • Having a telephone or mobile phone contact
  • 1. Not having smoked any cigarette in the past 30 days

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • School of Nursing, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official 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

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

Read the 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

Being tested
Brief AWARD advice, Nicotine replacement therapy sampling, Active referral, Very brief advice, Leaflet
Keywords
tobacco dependence treatment, combined brief intervention, AWARD advice, active referral, nicotine replacement therapy, pregnancy, family health, Chinese
Medical subject headings
Smoking Cessation, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief AWARD adviceBehavioural

    Also called Ask, Warn, Advise, Refer and Do-it-again

    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

  • Nicotine replacement therapy samplingDrug

    Also called NRT sample

    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.

  • Active referralBehavioural

    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 adviceBehavioural

    Also called VBA

    Subjects will receive general advice to quit

  • LeafletBehavioural

    Also called Print-based material

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

Study groups in NCT03671707
Study groupRoleWhat they receive
Intervention groupExperimentalBrief AWARD advice + Nicotine replacement therapy sampling + Active referral
Receives: Behavioral: Brief AWARD advice; Drug: Nicotine replacement therapy sampling; Behavioral: Active referral
Control groupActive comparatorVery brief advice (VBA) + Leaflet
Receives: Behavioral: Very brief advice; Behavioral: Leaflet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically-validated abstinence

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

    Measured: 6-month after baseline

Secondary outcomes (15)

  1. Self-reported past 7-day abstinence

    Being completely smoke-free in the past 7 days

    Measured: 3-month after baseline

  2. Self-reported past 7-day abstinence

    Being completely smoke-free in the past 7 days

    Measured: 6-month after baseline

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

    Being completely smoke-free in the past 24-week

    Measured: 6-month after baseline

  4. Smoking reduction

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

    Measured: 3-month after baseline

  5. Smoking reduction

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

    Measured: 6-month after baseline

  6. Smoking cessation service use

    Any access to a smoking cessation service

    Measured: 3-month after baseline

  7. Smoking cessation service use

    Any access to a smoking cessation service

    Measured: 6-month after baseline

  8. Use of nicotine replacement therapy

    Any use of nicotine replacement therapy

    Measured: 3-month after baseline

  9. Use of nicotine replacement therapy

    Any use of nicotine replacement therapy

    Measured: 6-month after baseline

  10. Change in nicotine dependence

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

    Measured: 3-month after baseline

  11. Change in nicotine dependence

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

    Measured: 6-month after baseline

  12. Number of quit attempt

    Defined by abstinence for at least 24 hours

    Measured: 3-month after baseline

  13. Number of quit attempt

    Defined by abstinence for at least 24 hours

    Measured: 6-month after baseline

  14. Intention to quit

    Defined by readiness to quit in 30 days

    Measured: 3-month after baseline

  15. Intention to quit

    Defined by readiness to quit in 30 days

    Measured: 6-month after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start10 Oct 2018
  3. Primary completion31 Oct 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671707
Sponsor's protocol ID
15162691
Other IDs
HKUCTR-2422
Acronym
BANSAR
Status last verified
Aug 2021
First submitted
12 Sep 2018
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 34125135

  • 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.

    PubMed 32320843

Questions about this trial

What is this clinical trial studying?

A study testing Brief AWARD advice, Nicotine replacement therapy sampling and Active referral in people with Smoking Cessation and Tobacco Use Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically-validated abstinence (time frame: 6-month after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671707, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.

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BANSAR Clinical Trial NCT03671707 | AzTrials