Clinical trial NCT03671707: Brief Advice, Nicotine Replacement Therapy Sampling and Active Referral (BANSAR) for Smoking Fathers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Use Cessation
Keywords: tobacco dependence treatment
combined brief intervention
AWARD advice
active referral
nicotine replacement therapy
pregnancy
family health
Chinese
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
name: Queen Mary Hospital, Hong Kong
name: Pamela Youde Nethersole Eastern Hospital
name: Kwong Wah Hospital
name: Queen Elizabeth Hospital, Hong Kong
name: United Christian Hospital
name: Princess Margaret Hospital, Hong Kong
name: Tuen Mun Hospital
First posted: 2018-09-14
Enrollment: 1053
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically-validated abstinence
timeFrame: 6-month after baseline
Secondary outcomes:
measure: Self-reported past 7-day abstinence
timeFrame: 3-month after baseline
measure: Self-reported past 7-day abstinence
timeFrame: 6-month after baseline
measure: Self-reported continuous abstinence in the past 24-week
timeFrame: 6-month after baseline
measure: Smoking reduction
timeFrame: 3-month after baseline
measure: Smoking reduction
timeFrame: 6-month after baseline
measure: Smoking cessation service use
timeFrame: 3-month after baseline
measure: Smoking cessation service use
timeFrame: 6-month after baseline
measure: Use of nicotine replacement therapy
timeFrame: 3-month after baseline
measure: Use of nicotine replacement therapy
timeFrame: 6-month after baseline
measure: Change in nicotine dependence
timeFrame: 3-month after baseline
measure: Change in nicotine dependence
timeFrame: 6-month after baseline
measure: Number of quit attempt
timeFrame: 3-month after baseline
measure: Number of quit attempt
timeFrame: 6-month after baseline
measure: Intention to quit
timeFrame: 3-month after baseline
measure: Intention to quit
timeFrame: 6-month after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.