Smoking CessationNCT05370352
Mobile Chat Messaging for Smoking Relapse Prevention
A study testing Standard smoking cessation treatment, Personalised chat messaging and SMS text messaging in people with Smoking Cessation, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. Taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in… 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?
- Standard smoking cessation treatment, Personalised chat messaging and SMS text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 2 sitesHong Kong
- Study dates
- 14 Mar 2023to 10 Aug 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
- Hong Kong residents aged 18 years or above
- Own a smartphone with WhatsApp installed
- Enrolled in a smoking cessation program under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
- Smoked daily before the present quit attempt
- Abstained from smoking for 3 to 30 days
Who cannot join
- Diagnosed with a mental disease or on regular psychotropic drugs
- Participating in other ongoing smoking cessation studies
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
Hong Kong
United Christian Nethersole Community Health Service Smoking Cessation Programme
Hong Kong
About this study
Official title: Effectiveness of Mobile Chat Messaging for Preventing Relapse in Smokers Who Have Recently Quit Smoking: a Randomised Controlled Trial
Most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. Taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in promoting successful quitting in people who recently quit smoking (recent abstainers) using a randomised controlled trial design.
Read the detailed description
Most smokers who made quit attempts and achieved short-term abstinence return to smoking (relapse) over time, even when aided by effective smoking cessation treatment. Since relapse mostly occurred in the first 4 weeks of abstinence, relapse prevention in the early phase of abstinence could potentially boost long-term abstinence. Several behavioural interventions for smoking relapse prevention have been proposed and tested in RCTs. Yet, a 2019 Cochrane review did not find traditional approaches, including self-help materials, telephone counselling and group therapy, effective in increasing long-term abstinence at 6 months or longer.
The widespread use of mobile devices has provided a highly accessible and scalable means for novel behavioural interventions for smoking cessation. A formative qualitative study in current smokers conducted by the investigators showed that mobile chat messaging is a feasible and acceptable platform for delivering smoking cessation support. A subsequent cluster randomised controlled trial on 1148 smokers found that mobile chat messaging combined with brief intervention was effective in increasing biochemically validated abstinence at 6 months. Nonetheless, whether mobile chat messaging could prevent relapse in recent abstainers has remained untested.
The investigators did a pilot trial to confirm the feasibility and acceptability of mobile chat messaging for relapse prevention in recent abstainers. This study aims to evaluate the effectiveness of mobile chat messaging relapse prevention intervention in promoting abstinence in recent abstainers.
- Conditions
- Smoking Cessation
- Being tested
- Standard smoking cessation treatment, Personalised chat messaging, SMS text messaging
- Keywords
- relapse prevention, recurrence, mHealth, instant messaging, WhatsApp, chatbot, conversational agent, Chinese
- Medical subject headings
- Smoking Cessation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard smoking cessation treatmentBehavioural
Standard smoking cessation treatment (behavioural and pharmacotherapy) provided by Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
Personalised chat messagingBehavioural
Personalised chat messaging focusing on smoking relapse prevention for 3 months from randomisation. A trained counsellor will interact with a participant individually and provide relapse prevention advice via WhatsApp. The participant can also access a supportive chatbot in WhatsApp, which will provide on-demand smoking relapse prevention support when the counsellor is not available (e.g., during nighttime).
SMS text messagingBehavioural
SMS text messaging on generic information about the harms of smoking and the benefits of quitting for 3 months from randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Mobile chat messaging | Experimental | Standard smoking cessation treatment + Personalised chat messaging Receives: Behavioral: Standard smoking cessation treatment; Behavioral: Personalised chat messaging |
| SMS messaging | Active comparator | Standard smoking cessation treatment + Regular SMS text messaging generic information about the harms of smoking and the benefits of quitting Receives: Behavioral: Standard smoking cessation treatment; Behavioral: SMS text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated tobacco abstinence
Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test
Measured: 6 months after randomisation
Secondary outcomes (9)
Self-reported 6-month prolonged tobacco abstinence
Not more than five lapses permitted for 6 months after baseline
Measured: 6 months after randomisation
Self-reported 7-day point prevalent tobacco abstinence
Being completely smoke-free in the past 7 days
Measured: 3 months after randomisation
Self-reported 7-day point prevalent tobacco abstinence
Being completely smoke-free in the past 7 days
Measured: 6 months after randomisation
Self-reported relapse rate
Defined as use of tobacco products for 7 consecutive days or longer
Measured: 3 months after randomisation
Self-reported relapse rate
Defined as use of tobacco products for 7 consecutive days or longer
Measured: 6 months after randomisation
Biochemically validated tobacco abstinence
Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test
Measured: 12 months after randomisation
Self-reported 12-month prolonged tobacco abstinence
Not more than five lapses permitted for 12 months after baseline
Measured: 12 months after randomisation
Self-reported 7-day point prevalent tobacco abstinence
Being completely smoke-free in the past 7 days
Measured: 12 months after randomisation
Self-reported relapse rate
Defined as use of tobacco products for 7 consecutive days or longer
Measured: 12 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start14 Mar 2023
- Primary completion16 Feb 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund, Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation, United Christian Nethersole Community Health Service Smoking Cessation Programme
- Responsible party
- Principal investigator, Tzu Tsun Luk, The University of Hong Kong
- Investigators
- Tzu Tsun Luk, PhD, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370352
- Sponsor's protocol ID
- 19201341
- Status last verified
- Apr 2025
- First submitted
- 6 May 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Request to obtain IPD can be made to the principal invesitgator on reasonable request
Publications
Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954.
PubMed 30702431Luk TT, Li WHC, Cheung DYT, Wong SW, Kwong ACS, Lai VWY, Chan SS, Lam TH, Wang MP. Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial. Contemp Clin Trials. 2019 Feb;77:70-75. doi: 10.1016/j.cct.2018.12.013. Epub 2018 Dec 26.
PubMed 30593882Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.
PubMed 33323188Luk 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 35166327Luk TT, Su X, Wong V, Chan HC, Wong GN, Lee JKH, Ho SY, Lam TH, Cheung YTD, Wang MP. Mobile Chat Messaging for Smoking Relapse Prevention: A Randomized Clinical Trial. JAMA Intern Med. 2026 Mar 1;186(3):294-302. doi: 10.1001/jamainternmed.2025.7439.
PubMed 41557345Su X, Wong V, Cheung YTD, Chan HC, Wong GN, Lee JKH, Ho SY, Wang MP, Luk TT. Mobile chat messaging for preventing relapse among people who recently quit smoking: Study protocol for a randomized controlled trial. Digit Health. 2024 Oct 21;10:20552076241291709. doi: 10.1177/20552076241291709. eCollection 2024 Jan-Dec.
PubMed 39439726
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Chat Messaging for Preventing Relapse in Smokers Who Have Recently Quit Smoking: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05370352
- Acronym / sponsor ID
- 19201341
- Conditions
- Smoking Cessation
- Keywords
- relapse prevention, recurrence, mHealth, instant messaging, WhatsApp, chatbot, conversational agent, Chinese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund, Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation, United Christian Nethersole Community Health Service Smoking Cessation Programme
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 16 Feb 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 11 May 2022 (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.
Most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. Taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in promoting successful quitting in people who recently quit smoking (recent abstainers) using a randomised controlled trial design.
Detailed description
Most smokers who made quit attempts and achieved short-term abstinence return to smoking (relapse) over time, even when aided by effective smoking cessation treatment. Since relapse mostly occurred in the first 4 weeks of abstinence, relapse prevention in the early phase of abstinence could potentially boost long-term abstinence. Several behavioural interventions for smoking relapse prevention have been proposed and tested in RCTs. Yet, a 2019 Cochrane review did not find traditional approaches, including self-help materials, telephone counselling and group therapy, effective in increasing long-term abstinence at 6 months or longer.
The widespread use of mobile devices has provided a highly accessible and scalable means for novel behavioural interventions for smoking cessation. A formative qualitative study in current smokers conducted by the investigators showed that mobile chat messaging is a feasible and acceptable platform for delivering smoking cessation support. A subsequent cluster randomised controlled trial on 1148 smokers found that mobile chat messaging combined with brief intervention was effective in increasing biochemically validated abstinence at 6 months. Nonetheless, whether mobile chat messaging could prevent relapse in recent abstainers has remained untested.
The investigators did a pilot trial to confirm the feasibility and acceptability of mobile chat messaging for relapse prevention in recent abstainers. This study aims to evaluate the effectiveness of mobile chat messaging relapse prevention intervention in promoting abstinence in recent abstainers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile chat messaging | Experimental | Behavioral: Standard smoking cessation treatment, Behavioral: Personalised chat messagingStandard smoking cessation treatment + Personalised chat messaging |
| SMS messaging | Active comparator | Behavioral: Standard smoking cessation treatment, Behavioral: SMS text messagingStandard smoking cessation treatment + Regular SMS text messaging generic information about the harms of smoking and the benefits of quitting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents aged 18 years or above
- Own a smartphone with WhatsApp installed
- Enrolled in a smoking cessation program under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
- Smoked daily before the present quit attempt
- Abstained from smoking for 3 to 30 days
Key exclusion criteria (2 listed)
- Diagnosed with a mental disease or on regular psychotropic drugs
- Participating in other ongoing smoking cessation studies
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 |
|---|---|---|
| Standard smoking cessation treatmentStandard smoking cessation treatment (behavioural and pharmacotherapy) provided by Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation | Behavioural | Mobile chat messaging, SMS messaging |
| Personalised chat messagingPersonalised chat messaging focusing on smoking relapse prevention for 3 months from randomisation. A trained counsellor will interact with a participant individually and provide relapse prevention advice via WhatsApp. The participant can also access a supportive chatbot in WhatsApp, which will provide on-demand smoking relapse prevention support when the counsellor is not available (e.g., during nighttime). | Behavioural | Mobile chat messaging |
| SMS text messagingSMS text messaging on generic information about the harms of smoking and the benefits of quitting for 3 months from randomisation. | Behavioural | SMS messaging |
Primary outcome
Biochemically validated tobacco abstinence
Time frame: 6 months after randomisation
Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test
9 secondary outcomes
Self-reported 6-month prolonged tobacco abstinence
Time frame: 6 months after randomisation
Self-reported 7-day point prevalent tobacco abstinence
Time frame: 3 months after randomisation
Self-reported 7-day point prevalent tobacco abstinence
Time frame: 6 months after randomisation
Self-reported relapse rate
Time frame: 3 months after randomisation
Self-reported relapse rate
Time frame: 6 months after randomisation
Biochemically validated tobacco abstinence
Time frame: 12 months after randomisation
Self-reported 12-month prolonged tobacco abstinence
Time frame: 12 months after randomisation
Self-reported 7-day point prevalent tobacco abstinence
Time frame: 12 months after randomisation
Self-reported relapse rate
Time frame: 12 months after randomisation
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 20 Nov 2025.
- Background: PubMed 30702431Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954.
- Background: PubMed 30593882Luk TT, Li WHC, Cheung DYT, Wong SW, Kwong ACS, Lai VWY, Chan SS, Lam TH, Wang MP. Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial. Contemp Clin Trials. 2019 Feb;77:70-75. doi: 10.1016/j.cct.2018.12.013. Epub 2018 Dec 26.
- Background: PubMed 33323188Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.
- Background: PubMed 35166327Luk 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.
- Derived from this study: PubMed 41557345Luk TT, Su X, Wong V, Chan HC, Wong GN, Lee JKH, Ho SY, Lam TH, Cheung YTD, Wang MP. Mobile Chat Messaging for Smoking Relapse Prevention: A Randomized Clinical Trial. JAMA Intern Med. 2026 Mar 1;186(3):294-302. doi: 10.1001/jamainternmed.2025.7439.
- Derived from this study: PubMed 39439726Su X, Wong V, Cheung YTD, Chan HC, Wong GN, Lee JKH, Ho SY, Wang MP, Luk TT. Mobile chat messaging for preventing relapse among people who recently quit smoking: Study protocol for a randomized controlled trial. Digit Health. 2024 Oct 21;10:20552076241291709. doi: 10.1177/20552076241291709. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No. Request to obtain IPD can be made to the principal invesitgator on reasonable 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.
Tzu Tsun Luk, PhD, RN principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard smoking cessation treatment, Personalised chat messaging and SMS text messaging in people with Smoking Cessation, run by The University of Hong Kong at 2 sites 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 5 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Biochemically validated tobacco abstinence (time frame: 6 months after randomisation). 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 NCT05370352, which also lists 6 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 20 Nov 2025.