Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-03-18
2026-04-01
Brief Summary
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Detailed Description
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This study will be a two-arm, parallel pilot randomized trial with follow-ups at 1-, 3-, and 6-month since enrolment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. Surveys will be collected via telephone and children's saliva will be collected face-to-face at 3-months and 6-months after randomisation using Alere iScreen OFD saliva cotinine test device. Semi-structured individual telephone or face-to-face in-depth interviews will be conducted with the participants in the intervention group at 6 months follow-up to explore the participants' perception towards the intervention.
This study's clinical outcome will be biochemically validated abstinence at 3 months after randomisation. Secondary outcomes include validated abstinence at 6 months after randomisation, self-reported 7-day point prevalence abstinence (PPA), 24-hour quit attempts, and smoking reduction by at least 50% at 3 and 6 months. Incentives of HK$200 will be given to participants who report 7-day PPA at 1 month post randomisation. Additionally, incentives of HK$ 500 will be provided for the completion of each biochemical validation (a total $1000 for validation at 3- and 6-month). Such an amount can increase the response rate in our experience. Another incentive of $200 will be given to subjects completing qualitative interviews.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Intervention group
A 1-week free sample of NRT patch or gum will be provided to encourage quit attempt without the pressure of quitting successfully. mHealth messages will be provided to motivate and support quitting and improve the protection measured of SHS exposure for children throughout the intervention period of 3 months.
Nicotine Replacement Therapy (NRT) Sampling
Participants will be advised to choose the NRT according to their preferences and daily cigarette consumption. Cigarette consumption of ≤20 daily will receive the 14mg patch or 2mg gum and participants consume \>20 cigarettes daily will receive the 21mg patch. An NRT use card (Appendix 6 draft) containing the instructions and potential side effects were given with a brief oral explanation. Full course of pharmacological treatment for 12-week are available in smoking cessation services. Participants requesting for additional or full course of NRT will be actively refer to the respective services as part of the Referral step in the AWARD model (Ask, Warn, Advise, Refer, and Do-it-again).
mHealth-based motivational counselling
The mHealth intervention will be delivered via the most popular instant messaging app in Hong Kong (WhatsApp). A total of 24 messages with contents including the harms of smoking and smoke exposure for children, encouragement, benefits of quitting for children, methods of quitting, dealing with craving, and measures to reduce cigarette smoke exposure at home will be provided. The messages will be scheduled in a tapering schedule that participants will receive 5 messages in the first week, then cut down to 3 messages/week for the next 4 weeks and 1 message/week for the last 7 weeks. Using a more personalized approach, the messages will be tailored to the participants' motivation, intention to quit and other quitting patterns collected at baseline. Real-time conversations could be initiated by participants themselves, triggered by regular messages, or through prompt inquires (e.g., asking about the quitting progress).
Brief cessation advice and self-help material
At baseline, participants will receive brief face-to-face advice on quitting smoking for the health of the children using the validated AWARD model (Ask, Warn, Advise, Refer, Do-it-again) with a print-based self-help material providing detailed information on health hazards of SHS exposure on children, methods to deal with craving and withdrawal symptoms, and measures on preventing SHS exposure for children at home.
Control group
Participants in the control group will only receive brief advice on SHS protective measures. Self-help materials will also be provided without follow-up interventions.
Brief cessation advice and self-help material
At baseline, participants will receive brief face-to-face advice on quitting smoking for the health of the children using the validated AWARD model (Ask, Warn, Advise, Refer, Do-it-again) with a print-based self-help material providing detailed information on health hazards of SHS exposure on children, methods to deal with craving and withdrawal symptoms, and measures on preventing SHS exposure for children at home.
Interventions
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Nicotine Replacement Therapy (NRT) Sampling
Participants will be advised to choose the NRT according to their preferences and daily cigarette consumption. Cigarette consumption of ≤20 daily will receive the 14mg patch or 2mg gum and participants consume \>20 cigarettes daily will receive the 21mg patch. An NRT use card (Appendix 6 draft) containing the instructions and potential side effects were given with a brief oral explanation. Full course of pharmacological treatment for 12-week are available in smoking cessation services. Participants requesting for additional or full course of NRT will be actively refer to the respective services as part of the Referral step in the AWARD model (Ask, Warn, Advise, Refer, and Do-it-again).
mHealth-based motivational counselling
The mHealth intervention will be delivered via the most popular instant messaging app in Hong Kong (WhatsApp). A total of 24 messages with contents including the harms of smoking and smoke exposure for children, encouragement, benefits of quitting for children, methods of quitting, dealing with craving, and measures to reduce cigarette smoke exposure at home will be provided. The messages will be scheduled in a tapering schedule that participants will receive 5 messages in the first week, then cut down to 3 messages/week for the next 4 weeks and 1 message/week for the last 7 weeks. Using a more personalized approach, the messages will be tailored to the participants' motivation, intention to quit and other quitting patterns collected at baseline. Real-time conversations could be initiated by participants themselves, triggered by regular messages, or through prompt inquires (e.g., asking about the quitting progress).
Brief cessation advice and self-help material
At baseline, participants will receive brief face-to-face advice on quitting smoking for the health of the children using the validated AWARD model (Ask, Warn, Advise, Refer, Do-it-again) with a print-based self-help material providing detailed information on health hazards of SHS exposure on children, methods to deal with craving and withdrawal symptoms, and measures on preventing SHS exposure for children at home.
Eligibility Criteria
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Inclusion Criteria
* Living with a child aged \<18 years who attended the clinic or were admitted to the pediatric ward
* Hong Kong residents able to read and communicate in Cantonese or Putonghua
* Children aged \<18 years who attended the clinic or were admitted to the pediatric ward
* Lives with at least one or more parents who smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
* Able to provide biochemical samples (e.g. saliva) for purpose of research
Exclusion Criteria
* Children who already have serious health diseases (e.g.chronic disease, genetic disease)
* Children who are participating in other clinical trials that may affect the results of this study
* Children who live in certain environments, such as those living in highly contaminated areas or areas with other potential disease-causing factors
18 Years
MALE
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Locations
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School of Nursing, The University of Hong Kong
Hong Kong, Pokfulam, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Sick Children
Identifier Type: -
Identifier Source: org_study_id
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