Cigarette SmokingQuit-for-LoveNCT07014124
Smoking Cessation for Fathers of Sick Children
A study testing Nicotine Replacement Therapy (NRT) Sampling, mHealth-based motivational counselling and Brief cessation advice and self-help material in people with Cigarette Smoking and mHealth Intervention, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The project aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model combined brief advice, nicotine replacement therapy sampling and mHealth-based individual counselling in increasing smoking abstinence for fathers of sick children. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cigarette Smoking, mHealth Intervention
- What is being tested?
- Nicotine Replacement Therapy (NRT) Sampling, mHealth-based motivational counselling and Brief cessation advice and self-help material
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Mar 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents (mainly fathers) aged ≥18 years and smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
- 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
- Owned a smartphone and can use an instant messaging app (e.g., WhatsApp, Facebook) Inclusion criteria for children
- 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
Who cannot join
- Smokers having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- Smokers using smoking cessation medications or other smoking cessation services or projects Exclusion criteria for children
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The University of Hong Kong
Hong Kong, Pokfulam, 999077
Shengzhi Zhao, PhD, +852 6561 4500, lubabezz@connect.hku.hk
Mengyao Lee, MPhil, +852 6851 8462, lmy0814@connect.hku.hk
About this study
Official title: mHealth-based Motivational Counselling Integrate With a Sample of Nicotine Replacement Therapy for Fathers of Sick Children Who Smoke Cigarettes: A Pilot Randomized Controlled Trial
The project aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model combined brief advice, nicotine replacement therapy sampling and mHealth-based individual counselling in increasing smoking abstinence for fathers of sick children.
Read the detailed description
Targeted participants are fathers of sick children who smoke daily in the past 7 days and live together with their children. The primary caregiver will be selected if both parents smoke. Participants will be recruited from pediatric wards/outpatient departments of Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. The recruitment will be extended to other public hospitals if needed.
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
- Cigarette Smoking, mHealth Intervention
- Being tested
- Nicotine Replacement Therapy (NRT) Sampling, mHealth-based motivational counselling, Brief cessation advice and self-help material
- Keywords
- tobacco exposure, sick children, quit smoking, Nicotine replacement therapy, mHealth support, smoking fathers
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (NRT) SamplingBehavioural
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 counsellingBehavioural
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 materialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Nicotine Replacement Therapy (NRT) Sampling; Behavioral: mHealth-based motivational counselling; Behavioral: Brief cessation advice and self-help material |
| Control group | Active comparator | 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. Receives: Behavioral: Brief cessation advice and self-help material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated abstinence
Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device
Measured: 3-months follow-ups
Secondary outcomes (17)
Biochemically validated abstinence
Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device
Measured: 6-month follow-up
Past 7-day point prevalence abstinence (PPA)
Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days?
Measured: 3-month follow-up
Past 7-day point prevalence abstinence (PPA)
Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days?
Measured: 6-month follow-up
Smoking reduction
50% or above reduction in cigarette consumption compared with baseline
Measured: 3-month follow-up
Smoking reduction
50% or above reduction in cigarette consumption compared with baseline
Measured: 6-month follow-up
Use of smoking cessation services
Use of smoking cessation services will be measured by a self-reported question: Have you ever used smoking cessation services in the past 7 days?
Measured: 3-month follow-up
Use of smoking cessation services
Use of smoking cessation services will be measured by a self-reported question: Have you ever used smoking cessation services in the past 7 days?
Measured: 6-month follow-up
Respiratory symptoms
Respiratory symptoms will be measured by a self-reported question: Have you ever experienced respiratory symptoms in the past 7 days? If yes, please list.
Measured: 3-month follow-up
Respiratory symptoms
Respiratory symptoms will be measured by a self-reported question: Have you ever experienced respiratory symptoms in the past 7 days? If yes, please list.
Measured: 6-month follow-up
Perceived family well-being
Perceived family well-being will be measured by the Family Apgar Scale. The total scale ranges from 0 to 10, with the higher score indicating a healthier family function.
Measured: 3-month follow-up
Perceived family well-being
Perceived family well-being will be measured by the Family Apgar Scale. The total scale ranges from 0 to 10, with the higher score indicating a healthier family function.
Measured: 6-month follow-up
Self-reported life quality
Quality of life will be measured by the WHOQoL scale. The total score ranges 0 to 100, with higher scores indicates better quality of life.
Measured: 3-month follow-up
Self-reported life quality
Quality of life will be measured by the WHOQoL scale. The total score ranges 0 to 100, with higher scores indicates better quality of life.
Measured: 6-month follow-up
Self-reported secondhand exposure
Self-reported secondhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to secondhand smoke and when you are exposed to secondhand smoke.
Measured: 3-month follow-up
Self-reported secondhand exposure
Self-reported secondhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to secondhand smoke and when you are exposed to secondhand smoke.
Measured: 6-month follow-up
Self-reported thirdhand exposure
Self-reported thirdhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to thirdhand smoke and when you are exposed to thirdhand smoke.
Measured: 3-month follow-up
Self-reported thirdhand exposure
Self-reported thirdhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to thirdhand smoke and when you are exposed to thirdhand smoke.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start18 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014124
- Sponsor's protocol ID
- Sick Children
- Acronym
- Quit-for-Love
- Status last verified
- Jun 2025
- First submitted
- 16 Jan 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth-based Motivational Counselling Integrate With a Sample of Nicotine Replacement Therapy for Fathers of Sick Children Who Smoke Cigarettes: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07014124
- Acronym / sponsor ID
- Quit-for-Love / Sick Children
- Conditions
- Cigarette Smoking, mHealth Intervention
- Keywords
- tobacco exposure, sick children, quit smoking, Nicotine replacement therapy, mHealth support, smoking fathers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model combined brief advice, nicotine replacement therapy sampling and mHealth-based individual counselling in increasing smoking abstinence for fathers of sick children.
Detailed description
Targeted participants are fathers of sick children who smoke daily in the past 7 days and live together with their children. The primary caregiver will be selected if both parents smoke. Participants will be recruited from pediatric wards/outpatient departments of Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. The recruitment will be extended to other public hospitals if needed.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nicotine Replacement Therapy (NRT) Sampling, Behavioral: mHealth-based motivational counselling, Behavioral: Brief cessation advice and self-help materialA 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. |
| Control group | Active comparator | Behavioral: Brief cessation advice and self-help materialParticipants in the control group will only receive brief advice on SHS protective measures. Self-help materials will also be provided without follow-up interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Parents (mainly fathers) aged ≥18 years and smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
- 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
- Owned a smartphone and can use an instant messaging app (e.g., WhatsApp, Facebook) Inclusion criteria for children
- Children aged <18 years who attended the clinic or were admitted to the pediatric ward
Key exclusion criteria (5 listed)
- Smokers having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- Smokers using smoking cessation medications or other smoking cessation services or projects Exclusion criteria for children
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy (NRT) SamplingParticipants 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). | Behavioural | Intervention group |
| mHealth-based motivational counsellingThe 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). | Behavioural | Intervention group |
| Brief cessation advice and self-help materialAt 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. | Behavioural | Control group, Intervention group |
Primary outcome
Biochemically validated abstinence
Time frame: 3-months follow-ups
Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device
17 secondary outcomes
Biochemically validated abstinence
Time frame: 6-month follow-up
Past 7-day point prevalence abstinence (PPA)
Time frame: 3-month follow-up
Past 7-day point prevalence abstinence (PPA)
Time frame: 6-month follow-up
Smoking reduction
Time frame: 3-month follow-up
Smoking reduction
Time frame: 6-month follow-up
Use of smoking cessation services
Time frame: 3-month follow-up
Use of smoking cessation services
Time frame: 6-month follow-up
Respiratory symptoms
Time frame: 3-month follow-up
Respiratory symptoms
Time frame: 6-month follow-up
Perceived family well-being
Time frame: 3-month follow-up
Perceived family well-being
Time frame: 6-month follow-up
Self-reported life quality
Time frame: 3-month follow-up
Self-reported life quality
Time frame: 6-month follow-up
Self-reported secondhand exposure
Time frame: 3-month follow-up
Self-reported secondhand exposure
Time frame: 6-month follow-up
Self-reported thirdhand exposure
Time frame: 3-month follow-up
Self-reported thirdhand exposure
Time frame: 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy (NRT) Sampling, mHealth-based motivational counselling and Brief cessation advice and self-help material in people with Cigarette Smoking and mHealth Intervention, 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengzhi Zhao, PhD (+852 6561 4500, lubabezz@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated abstinence (time frame: 3-months follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.