Smoking CessationNCT06261385
Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
A study testing typology-based intervention and Routine Treatment in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- typology-based intervention and Routine Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a daily smoker before enrolling into the smoking cessation service
- Not using cigarettes for past 7 days
- Received at least 4 weeks of smoking cessation service before enrolling into the study
- Aged 18 years or above
- No barriers in speaking and listening Cantonese and Mandarin and reading Chinese
- SC counsellors from local SC clinics under Tung Wah Group of Hospitals Integrated Center on Smoking Cessation and United Christian Nethersole Community Health Service
Who cannot join
- Have unstable physical or psychological conditions as advised by doctors or counsellors
- Have become pregnant in the past two months
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.
Read the detailed description
This pilot study includes three phases. The first phase will be a Q-sorting process on the Q-statements which have been developed in the pilot study. Phase 2 will be the development of a typology assessment tool, intervention protocol, and training. Phase 3 will be a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the typology-based intervention. Ethics approval will be obtained from the Institutional Review Board of the University of Hong Kong/Hong Kong Authority Hong Kong West Cluster.
This study protocol complies with the Declaration of Helsinki and the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP).
Phase 1 Q-method study (5 months) In phase 1, ex-smokers will be recruited online and in local community-based SC clinics. Mass mails including study details will be sent to all HKU staff and students. Recruitment ads will also be posted on online platforms such as Google, Facebook, and Instagram. Participants will be directed to an online Qualtrics to complete a brief screening questionnaire and provide their contact information for the sign-up process. SC clinics or services under Tung Wah Group of Hospitals, Pok Oi Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong, which offer behaviour and/or pharmacological interventions. The investigators have successful experience collaborating with these service providers in recruiting smokers for several projects. For example, the investigators recruited 1,008 ex-smokers from these service providers in an HMRF-funded project in 2018-2019 (Project No. 15163001). In these clinics, potential participants shall be identified by the SC counsellors and referred to our research assistants to proceed with enrolment. In phase 3, the investigators will only recruit ex-smokers from SC clinics, because biochemical verification of both abstinence and habitual tobacco use before quitting in ex-smokers recruited from the community does not exist.
The Q-statements have been developed in our aforementioned pilot study. The Q-sorting process will be conducted on an online platform "easyHTMLQ" (Appendix 2), which is designed for completion of the Q-sorting. In this self-explanatory website, participants can easily drag the statements into the Q-sort grid according to their agreement level, and provide detailed reasons for their choices. Also, the research assistant will communicate with participants online and monitor the Q-sorting process. After the Q-sort process, the results will be documented and exported for further data analysis.
Phase 2 Intervention development (6 months) In phase 2, the investigators shall invite SC counsellors from the above SC clinics to participate in either face-to-face or online project meetings to provide feedback on the intervention protocols.
This phase aims to develop a typology assessment tool and design a typology-based intervention protocol, using the findings in Phase 1, the 3 aforementioned principles of typology-based intervention, and current smoking cessation guidelines. The screening protocol will include distinguishing statements found in Phase 1 that can characterise ex-smokers. The intervention protocol will include specific counselling principles and content for each ex-smoker class and a series of typology-based e-messages to be delivered to the corresponding class of ex-smokers via WhatsApp after counselling. The counselling shall take 5 to 10 minutes and can be fitted in current intervention protocols (5A/5R/Motivational Interview), that can address quit motivation, smoking cues and nicotine dependence.
After intervention development, the project team will invite SC counsellors for a project meeting to provide feedback on the intervention protocols. Afterwards, the project team shall revise the protocols and deliver a briefing for the SC counsellors who will deliver the intervention in Phase 3.
Phase 3 Pilot randomized control trial (7 months) The pilot 2-arm, parallel, open-labelled RCT (allocation ratio 1:1) aims to examine the feasibility, acceptability and preliminary efficacy of the typology-based intervention. SC counsellors who attend the briefing in Phase 2 will screen and recruit their SC clients to receive the typology-based intervention for smoking cessation. The SC counsellors from local clinical settings that can recruit a relatively large number of participants within the 12-week recruitment will be included, to ensure timely recruitment of sufficient participants.
During the last remote consultation with a client (mostly at 4 weeks), the SC counsellors will assess their eligibility. If they are eligible, the SC counsellors will seek their written consent and randomize them to either the intervention group or the control group. In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by our research staff for 4 weeks.
In the control group, routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and no e-messages will be sent. The investigators only deploy usual practice but not equal contact/attention treatment for the control group because the investigators aim for a superiority trial to assess the preliminary efficacy of the new intervention.
- Conditions
- Smoking Cessation
- Being tested
- typology-based intervention, Routine Treatment
- Keywords
- Q-methdololgy, Relapse Prevention, Randomized Controlled Trial
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
typology-based interventionBehavioural
The typology-based intervention includes:
- typology-based counselling,
- personalized E-message based on the counselling content discussed
- a booklet introducing the typology of quit identity.
All interventions and materials are delivered by smoking counselling.
Routine TreatmentBehavioural
The routine smoking cessation intervention includes:
- Routine counselling generic advice on preventing smoking relapse
- Brief e-messages that consist of general quit advice for 4 weeks.
Counsellors implement both routine practices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by the counsellor for 4 weeks. Receives: Behavioral: typology-based intervention |
| Control Group | Active comparator | In the control group, the routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and they will receive brief e-messages that only consist of general quit advice for 4 weeks. Receives: Behavioral: Routine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported abstinence in the past 30 days at 2-month follow-up
Measured: 2 months
iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence
Participants who report tobacco abstinence will be invited for a biochemical validation to test if his/her saliva cotinine is less than 30ng/ml measured by the iScreen OFD Cotinine Saliva Test Kit.
Measured: 2 months
the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
We will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree).
Also, we will have 4 acceptability questions for ex-smokers to answer. We would like to observe if there is a difference between the intervention group and the control group
Measured: 2 months
Secondary outcomes (16)
Time required for the counselling
The average time required for the typological counselling in minutes
Measured: End of all follow-up (approximately 6 month)
Compliance rate of the SC counsellors in following the intervention protocol
There were 26 questions in the counselling protocol. SC counsellors have to record the number of questions asked during the typological counselling. The rate is calculated by "number of questions asked"/26.
Measured: End of all follow-up (approximately 6 month)
Proportion of screened clients who participate in the RCT
The proportion is calculated by "Number of enrolled participants" / "Total number of participant screened"
Measured: End of all follow-up (approximately 6 month)
Dropout rate of the participants who consent to the RCT
The dropout rate is calculated by "Number of participants dropout from study" / "Total number of enrolled participant"
Measured: End of all follow-up (approximately 6 month)
Satisfaction on the SC counsellors
Satisfaction on the SC counsellors is measured by a 5 point Likert scale reported by the enrolled participants.
Measured: 2 months
Satisfaction on the e-messages
Satisfaction on the e-messages is measured by a 10 point Likert scale reported by the enrolled participants.
Measured: 2 months
Frequency of reading the e-messages
The Frequency of reading the e-messages is measured by 5 point Likert scale, which includes the option (5) I read all of them, (4) I read most of them, (3) I read half of them, (2) I read some of them, and (1) I read none of them.
Measured: 2 months
Perceived effectiveness on the intervention
The perceived effectiveness on the intervention is measured by a 10 point likert scale. Participant will rate the usefulness of the messages in helping them to maintain smoking abstinence (10: Very useful | 0: Useless).
Measured: 2 months
Satisfaction on the enrolment procedures
Satisfaction on the enrolment procedures is measured by a 10 point Likert scale reported by the participants (0: The enrollment procedure is slow and complicated | 10: the enrollment procedure is fast and simple).
Measured: 2 months
Intention to recommend the intervention to other smokers
Intention to recommend the intervention to other smokers is measured by a 10 point Likert scale, 10: strongly recommended to other smokers | 0: not recommended to other smoker
Measured: 2 months
Satisfaction about the intervention from SC counsellor
Satisfaction about the intervention from SC counsellor is measured by a 5 point Likert scale. SC counsellor will rate the effectiveness of the typological counselling in helping their client to quit smoking, from 1: very ineffective to 5: very effective.
Measured: End of all follow-up (approximately 6 month)
Perceived appropriateness of the intervention length from SC counsellor
The perceived appropriateness of the intervention length from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the length of the typological counselling is suitable for their client, from 1 strongly disagree to 5 strongly agree.
Measured: End of all follow-up (approximately 6 month)
Satisfaction on the enrolment and counselling procedures from SC counsellors
The satisfaction on the enrolment procedures from SC counsellors is measured by a 5 point Likert scale. Counsellors will be asked if they agreed that enrolment and counselling procedures is simple and could be easily done in the SC clinics, from 1: strongly disagree to 5: strongly agree.
Measured: End of all follow-up (approximately 6 month)
Perceived effectiveness of the screening tool from SC counsellor
The perceived effectiveness of the screening tool from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the typological intervention can help them screen out smokers who are prone to relapse, from 1: strongly disagree to 5: strongly agree.
Measured: End of all follow-up (approximately 6 month)
Perceived clients' acceptance of the intervention from SC counsellor
The Perceived clients' acceptance of the intervention from SC counsellor is measured by a 5 point Likert scale. Participants are asked if they agreed that counselling content provided the SC counselling gain their trust and acceptance, from 1: strongly disagree to 5: strongly agree.
Measured: 2 months
Intention to apply this intervention in other clients from SC counsellors
Intention to apply this intervention in other clients from SC counsellors is measured by a 5 point Likert scale. SC counsellors are asked if they want to apply the typological intervention to other clients in future, 1: I will not apply it to my client in the future, 5: I want to apply it my client in the future.
Measured: End of all follow-up (approximately 6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start23 Jan 2024
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm: Intervention group and Control group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Dr. Derek Yee-Tak Cheung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261385
- Sponsor's protocol ID
- typology
- Status last verified
- Jun 2025
- First submitted
- 29 Jan 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data and documentation will be available upon request
Publications
McGhee SM, Ho LM, Lapsley HM, Chau J, Cheung WL, Ho SY, Pow M, Lam TH, Hedley AJ. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control. 2006 Apr;15(2):125-30. doi: 10.1136/tc.2005.013292.
PubMed 16565461Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 70: Pattern of Smoking. Hong Kong: Census & Statistics Department 2020.
World Health Organization. A guide for tobacco users to quit. Geneva: World Health Organization; 2014.
Lam TH. Absolute risk of tobacco deaths: one in two smokers will be killed by smoking: comment on "Smoking and all-cause mortality in older people". Arch Intern Med. 2012 Jun 11;172(11):845-6. doi: 10.1001/archinternmed.2012.1927. No abstract available.
PubMed 22688993Food and Health Bureau, Department of Health. Towards 2025: Strategy and action plan to prevent and control non-communicable diseases in Hong Kong. Hong Kong: Department of Health; 2018.
Hartmann-Boyce J, Livingstone-Banks J, Ordonez-Mena JM, Fanshawe TR, Lindson N, Freeman SC, Sutton AJ, Theodoulou A, Aveyard P. Behavioural interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD013229. doi: 10.1002/14651858.CD013229.pub2.
PubMed 33411338Jackson SE, McGowan JA, Ubhi HK, Proudfoot H, Shahab L, Brown J, West R. Modelling continuous abstinence rates over time from clinical trials of pharmacological interventions for smoking cessation. Addiction. 2019 May;114(5):787-797. doi: 10.1111/add.14549. Epub 2019 Jan 29.
PubMed 30614586Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.
PubMed 27060875Livingstone-Banks J, Norris E, Hartmann-Boyce J, West R, Jarvis M, Hajek P. Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD003999. doi: 10.1002/14651858.CD003999.pub5.
PubMed 30758045Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 64: Pattern of Smoking. Hong Kong: Census & Statistics Department 2018.
Smith AL, Chapman S, Dunlop SM. What do we know about unassisted smoking cessation in Australia? A systematic review, 2005-2012. Tob Control. 2015 Jan;24(1):18-27. doi: 10.1136/tobaccocontrol-2013-051019. Epub 2013 Sep 11.
PubMed 24026163Cheung YT, Chan CH, Lai CK, Chan WF, Wang MP, Li HC, Chan SS, Lam TH. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Oct 22;17(10):e238. doi: 10.2196/jmir.4829.
PubMed 26494159Luk TT, Cheung YTD, Chan HC, Fok PW, Ho KS, Sze CD, Lam TH, Wang MP. Mobile Chat Messaging for Preventing Smoking Relapse Amid the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Jan 5;25(2):291-297. doi: 10.1093/ntr/ntac045.
PubMed 35166327Tajfel H, Turner JC. The Social Identity Theory of Intergroup Behavior. In: Sidanius JTJJ, editor. Political psychology: Key readings. Key readings in social psychology. New York, NY, US: Psychology Press; 2004. p. 276-93.
Oyserman D, Smith GC, Elmore K. Identity-based motivation: Implications for health and health disparities. J Soc Iss. 2014;70(2):206-25.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06261385
- Acronym / sponsor ID
- typology
- Conditions
- Smoking Cessation
- Keywords
- Q-methdololgy, Relapse Prevention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Feb 2024 (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.
This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.
Detailed description
This pilot study includes three phases. The first phase will be a Q-sorting process on the Q-statements which have been developed in the pilot study. Phase 2 will be the development of a typology assessment tool, intervention protocol, and training. Phase 3 will be a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the typology-based intervention. Ethics approval will be obtained from the Institutional Review Board of the University of Hong Kong/Hong Kong Authority Hong Kong West Cluster.
This study protocol complies with the Declaration of Helsinki and the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP).
Phase 1 Q-method study (5 months) In phase 1, ex-smokers will be recruited online and in local community-based SC clinics. Mass mails including study details will be sent to all HKU staff and students. Recruitment ads will also be posted on online platforms such as Google, Facebook, and Instagram. Participants will be directed to an online Qualtrics to complete a brief screening questionnaire and provide their contact information for the sign-up process. SC clinics or services under Tung Wah Group of Hospitals, Pok Oi Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong, which offer behaviour and/or pharmacological interventions. The investigators have successful experience collaborating with these service providers in recruiting smokers for several projects. For example, the investigators recruited 1,008 ex-smokers from these service providers in an HMRF-funded project in 2018-2019 (Project No. 15163001). In these clinics, potential participants shall be identified by the SC counsellors and referred to our research assistants to proceed with enrolment. In phase 3, the investigators will only recruit ex-smokers from SC clinics, because biochemical verification of both abstinence and habitual tobacco use before quitting in ex-smokers recruited from the community does not exist.
The Q-statements have been developed in our aforementioned pilot study. The Q-sorting process will be conducted on an online platform "easyHTMLQ" (Appendix 2), which is designed for completion of the Q-sorting. In this self-explanatory website, participants can easily drag the statements into the Q-sort grid according to their agreement level, and provide detailed reasons for their choices. Also, the research assistant will communicate with participants online and monitor the Q-sorting process. After the Q-sort process, the results will be documented and exported for further data analysis.
Phase 2 Intervention development (6 months) In phase 2, the investigators shall invite SC counsellors from the above SC clinics to participate in either face-to-face or online project meetings to provide feedback on the intervention protocols.
This phase aims to develop a typology assessment tool and design a typology-based intervention protocol, using the findings in Phase 1, the 3 aforementioned principles of typology-based intervention, and current smoking cessation guidelines. The screening protocol will include distinguishing statements found in Phase 1 that can characterise ex-smokers. The intervention protocol will include specific counselling principles and content for each ex-smoker class and a series of typology-based e-messages to be delivered to the corresponding class of ex-smokers via WhatsApp after counselling. The counselling shall take 5 to 10 minutes and can be fitted in current intervention protocols (5A/5R/Motivational Interview), that can address quit motivation, smoking cues and nicotine dependence.
After intervention development, the project team will invite SC counsellors for a project meeting to provide feedback on the intervention protocols. Afterwards, the project team shall revise the protocols and deliver a briefing for the SC counsellors who will deliver the intervention in Phase 3.
Phase 3 Pilot randomized control trial (7 months) The pilot 2-arm, parallel, open-labelled RCT (allocation ratio 1:1) aims to examine the feasibility, acceptability and preliminary efficacy of the typology-based intervention. SC counsellors who attend the briefing in Phase 2 will screen and recruit their SC clients to receive the typology-based intervention for smoking cessation. The SC counsellors from local clinical settings that can recruit a relatively large number of participants within the 12-week recruitment will be included, to ensure timely recruitment of sufficient participants.
During the last remote consultation with a client (mostly at 4 weeks), the SC counsellors will assess their eligibility. If they are eligible, the SC counsellors will seek their written consent and randomize them to either the intervention group or the control group. In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by our research staff for 4 weeks.
In the control group, routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and no e-messages will be sent. The investigators only deploy usual practice but not equal contact/attention treatment for the control group because the investigators aim for a superiority trial to assess the preliminary efficacy of the new intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm: Intervention group and Control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: typology-based interventionIn the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by the counsellor for 4 weeks. |
| Control Group | Active comparator | Behavioral: Routine TreatmentIn the control group, the routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and they will receive brief e-messages that only consist of general quit advice for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being a daily smoker before enrolling into the smoking cessation service
- Not using cigarettes for past 7 days
- Received at least 4 weeks of smoking cessation service before enrolling into the study
- Aged 18 years or above
- No barriers in speaking and listening Cantonese and Mandarin and reading Chinese
Key exclusion criteria (2 listed)
- Have unstable physical or psychological conditions as advised by doctors or counsellors
- Have become pregnant in the past two months
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 |
|---|---|---|
| typology-based interventionThe typology-based intervention includes: 1. typology-based counselling, 2. personalized E-message based on the counselling content discussed 3. a booklet introducing the typology of quit identity. All interventions and materials are delivered by smoking counselling. | Behavioural | Intervention group |
| Routine TreatmentThe routine smoking cessation intervention includes: 1. Routine counselling generic advice on preventing smoking relapse 2. Brief e-messages that consist of general quit advice for 4 weeks. Counsellors implement both routine practices. | Behavioural | Control Group |
Primary outcome
self-reported abstinence in the past 30 days at 2-month follow-up
Time frame: 2 months
iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence
Time frame: 2 months
Participants who report tobacco abstinence will be invited for a biochemical validation to test if his/her saliva cotinine is less than 30ng/ml measured by the iScreen OFD Cotinine Saliva Test Kit.
the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
Time frame: 2 months
We will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree). Also, we will have 4 acceptability questions for ex-smokers to answer. We would like to observe if there is a difference between the intervention group and the control group
16 secondary outcomes
Time required for the counselling
Time frame: End of all follow-up (approximately 6 month)
Compliance rate of the SC counsellors in following the intervention protocol
Time frame: End of all follow-up (approximately 6 month)
Proportion of screened clients who participate in the RCT
Time frame: End of all follow-up (approximately 6 month)
Dropout rate of the participants who consent to the RCT
Time frame: End of all follow-up (approximately 6 month)
Satisfaction on the SC counsellors
Time frame: 2 months
Satisfaction on the e-messages
Time frame: 2 months
Frequency of reading the e-messages
Time frame: 2 months
Perceived effectiveness on the intervention
Time frame: 2 months
Satisfaction on the enrolment procedures
Time frame: 2 months
Intention to recommend the intervention to other smokers
Time frame: 2 months
Satisfaction about the intervention from SC counsellor
Time frame: End of all follow-up (approximately 6 month)
Perceived appropriateness of the intervention length from SC counsellor
Time frame: End of all follow-up (approximately 6 month)
Satisfaction on the enrolment and counselling procedures from SC counsellors
Time frame: End of all follow-up (approximately 6 month)
Perceived effectiveness of the screening tool from SC counsellor
Time frame: End of all follow-up (approximately 6 month)
Perceived clients' acceptance of the intervention from SC counsellor
Time frame: 2 months
Intention to apply this intervention in other clients from SC counsellors
Time frame: End of all follow-up (approximately 6 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 16565461McGhee SM, Ho LM, Lapsley HM, Chau J, Cheung WL, Ho SY, Pow M, Lam TH, Hedley AJ. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control. 2006 Apr;15(2):125-30. doi: 10.1136/tc.2005.013292.
- BackgroundCensus & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 70: Pattern of Smoking. Hong Kong: Census & Statistics Department 2020.
- BackgroundWorld Health Organization. A guide for tobacco users to quit. Geneva: World Health Organization; 2014.
- Background: PubMed 22688993Lam TH. Absolute risk of tobacco deaths: one in two smokers will be killed by smoking: comment on "Smoking and all-cause mortality in older people". Arch Intern Med. 2012 Jun 11;172(11):845-6. doi: 10.1001/archinternmed.2012.1927. No abstract available.
- BackgroundFood and Health Bureau, Department of Health. Towards 2025: Strategy and action plan to prevent and control non-communicable diseases in Hong Kong. Hong Kong: Department of Health; 2018.
- Background: PubMed 33411338Hartmann-Boyce J, Livingstone-Banks J, Ordonez-Mena JM, Fanshawe TR, Lindson N, Freeman SC, Sutton AJ, Theodoulou A, Aveyard P. Behavioural interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD013229. doi: 10.1002/14651858.CD013229.pub2.
- Background: PubMed 30614586Jackson SE, McGowan JA, Ubhi HK, Proudfoot H, Shahab L, Brown J, West R. Modelling continuous abstinence rates over time from clinical trials of pharmacological interventions for smoking cessation. Addiction. 2019 May;114(5):787-797. doi: 10.1111/add.14549. Epub 2019 Jan 29.
- Background: PubMed 27060875Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.
- Background: PubMed 30758045Livingstone-Banks J, Norris E, Hartmann-Boyce J, West R, Jarvis M, Hajek P. Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD003999. doi: 10.1002/14651858.CD003999.pub5.
- BackgroundCensus & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 64: Pattern of Smoking. Hong Kong: Census & Statistics Department 2018.
- Background: PubMed 24026163Smith AL, Chapman S, Dunlop SM. What do we know about unassisted smoking cessation in Australia? A systematic review, 2005-2012. Tob Control. 2015 Jan;24(1):18-27. doi: 10.1136/tobaccocontrol-2013-051019. Epub 2013 Sep 11.
- Background: PubMed 26494159Cheung YT, Chan CH, Lai CK, Chan WF, Wang MP, Li HC, Chan SS, Lam TH. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Oct 22;17(10):e238. doi: 10.2196/jmir.4829.
- Individual participant dataSharing planned: Yes. Research data and documentation will be available upon request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing typology-based intervention and Routine Treatment in people with Smoking Cessation, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 5 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported abstinence in the past 30 days at 2-month follow-up (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261385, which also lists 25 linked publications.
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 5 Jan 2026.