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| ID | Type | Description | Link |
|---|---|---|---|
| HKUCTR-2422 | Registry Identifier | HKU Clinical Trials Registry |
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| Name | Class |
|---|---|
| Food and Health Bureau, Hong Kong | OTHER_GOV |
| Queen Mary Hospital, Hong Kong | OTHER |
| Pamela Youde Nethersole Eastern Hospital | OTHER |
| Kwong Wah Hospital |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Brief AWARD advice + Nicotine replacement therapy sampling + Active referral |
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| Control group | Active Comparator | Very brief advice (VBA) + Leaflet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief AWARD advice | Behavioral | Subject will receive brief, face-to-face counselling following a structured AWARD model at baseline :
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| Measure | Description | Time Frame |
|---|---|---|
| Biochemically-validated abstinence | Defined by an exhaled carbon monoxide level of < 4 parts per million (ppm) | 6-month after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported past 7-day abstinence | Being completely smoke-free in the past 7 days | 3-month after baseline |
| Self-reported past 7-day abstinence | Being completely smoke-free in the past 7 days |
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Inclusion criteria for both expectant father and mother:
Inclusion criteria for expectant father:
Inclusion criteria for expectant mother:
1. Not having smoked any cigarette in the past 30 days
Exclusion Criteria for expectant father
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| Name | Affiliation | Role |
|---|---|---|
| Man Ping Wang, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, The University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34125135 | Derived | 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. | |
| 32320843 |
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| OTHER |
| Queen Elizabeth Hospital, Hong Kong | OTHER |
| United Christian Hospital | OTHER |
| Princess Margaret Hospital, Hong Kong | OTHER_GOV |
| Tuen Mun Hospital | OTHER_GOV |
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| 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. |
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| 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. |
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| Very brief advice | Behavioral | Subjects will receive general advice to quit |
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| Leaflet | Behavioral | Subjects will receive a standard leaflet on perinatal smoking by Department of Health |
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| 6-month after baseline |
| Self-reported continuous abstinence in the past 24-week | Being completely smoke-free in the past 24-week | 6-month after baseline |
| Smoking reduction | Defined by at least 50% reduction in baseline daily number of cigarettes | 3-month after baseline |
| Smoking reduction | Defined by at least 50% reduction in baseline daily number of cigarettes | 6-month after baseline |
| Smoking cessation service use | Any access to a smoking cessation service | 3-month after baseline |
| Smoking cessation service use | Any access to a smoking cessation service | 6-month after baseline |
| Use of nicotine replacement therapy | Any use of nicotine replacement therapy | 3-month after baseline |
| Use of nicotine replacement therapy | Any use of nicotine replacement therapy | 6-month after baseline |
| Change in nicotine dependence | Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence) | 3-month after baseline |
| Change in nicotine dependence | Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence) | 6-month after baseline |
| Number of quit attempt | Defined by abstinence for at least 24 hours | 3-month after baseline |
| Number of quit attempt | Defined by abstinence for at least 24 hours | 6-month after baseline |
| Intention to quit | Defined by readiness to quit in 30 days | 3-month after baseline |
| Intention to quit | Defined by readiness to quit in 30 days | 6-month after baseline |
| 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. |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C422209 | corticosteroid hormone-induced factor |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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