NCT03671707

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,053

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

2.1 years

First QC Date

September 12, 2018

Last Update Submit

August 16, 2021

Conditions

Smoking CessationTobacco Use Cessation

Keywords

tobacco dependence treatmentcombined brief interventionAWARD adviceactive referralnicotine replacement therapypregnancyfamily healthChinese

Outcome Measures

Primary Outcomes (1)

  • Biochemically-validated abstinence

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

    6-month after baseline

Secondary Outcomes (15)

  • Self-reported past 7-day abstinence

    3-month after baseline

  • Self-reported past 7-day abstinence

    6-month after baseline

  • Self-reported continuous abstinence in the past 24-week

    6-month after baseline

  • Smoking reduction

    3-month after baseline

  • Smoking reduction

    6-month after baseline

  • +10 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Brief AWARD advice + Nicotine replacement therapy sampling + Active referral

Behavioral: Brief AWARD adviceDrug: Nicotine replacement therapy samplingBehavioral: Active referral

Control group

ACTIVE COMPARATOR

Very brief advice (VBA) + Leaflet

Behavioral: Very brief adviceBehavioral: Leaflet

Interventions

Brief AWARD adviceBEHAVIORAL

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

Also known as: Ask, Warn, Advise, Refer and Do-it-again
Intervention group
Nicotine replacement therapy samplingDRUG

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.

Also known as: NRT sample
Intervention group
Active referralBEHAVIORAL

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.

Intervention group
Very brief adviceBEHAVIORAL

Subjects will receive general advice to quit

Also known as: VBA
Control group
LeafletBEHAVIORAL

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

Also known as: Print-based material
Control group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \. Not having smoked any cigarette in the past 30 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 34125135DERIVED

  • 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.

    PMID: 32320843DERIVED

MeSH Terms

Conditions

Smoking CessationTobacco Use Cessation

Interventions

corticosteroid hormone-induced factorReferral and Consultation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Man Ping Wang, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

October 10, 2018

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

HK(1)