Smoking CessationNCT07240545
Xylitol Gum for Promoting Smoking Cessation
A study testing Brief smoking cessation advice, Warning leaflet and Self-help smoking cessation booklet in people with Smoking Cessation and Health Promotion, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to learn if 4-week xylitol gum intervention works to promote smoking cessation in daily smokers. It will also learn about the feasibility and acceptability of using xylitol gum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Health Promotion
- What is being tested?
- Brief smoking cessation advice, Warning leaflet and Self-help smoking cessation booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Nov 2025to 30 Sep 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of Hong Kong aged 18 or above who smoke at least 1 cigarette per day over the past 3 months
- Have the habit of chewing gum or are willing to use chewing gum
- Can communicate in Cantonese (including reading Chinese)
- Express an intention to quit or reduce smoking
- Capable of using instant messaging tools (e.g., WhatsApp, WeChat) for communication
Who cannot join
- Have communication barriers (either physical or cognitive)
- Currently participating in other smoking cessation programs or services
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
School of Nursing, The University of Hong Kong
Hong Kong
Mengyao Li, 68518462, lmy0814@connect.hku.hk
About this study
Official title: The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial
The goal of this clinical trial is to learn if 4-week xylitol gum intervention works to promote smoking cessation in daily smokers. It will also learn about the feasibility and acceptability of using xylitol gum. The main questions it aims to answer are:
（1）Does xylitol gum help to reduce cigarette consumption and promote smoking cessation?
Researchers will compare 4-week xylitol gum intervention to the brief advice to see if xylitol gum works to promote smoking cessation.
Participants in the intervention group will receive a 3-month behavioral intervention comprising a 4-week xylitol gum aligned with 12 weeks of instant reminder message support.
Read the detailed description
This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a proactive smoking cessation intervention using xylitol chewing gum. Eligible participants will be Hong Kong residents aged ≥18 years who (1) have smoked at least one cigarette per day in the past 3 months; (2) can communicate in Cantonese (including reading Chinese); (3) express an intention to quit or reduce smoking; (4) are able to use instant messaging tools (e.g., WhatsApp); and (5) regularly chew gum or are willing to use chewing gum for smoking reduction.
A total of 134 participants will be recruited from community settings, including public housing estates across Hong Kong's 18 districts, community and university smoking hotspots, referrals from other smoking cessation programmes, and social media promotions (Facebook and Instagram). The study will adopt a hybrid type I effectiveness-implementation design. Participants will be followed up at 1, 3, and 6 months post-enrolment via telephone, following CONSORT guidelines, to assess cigarette reduction and cessation outcomes.
All participants will receive brief smoking cessation advice at baseline using the AWARD model (Ask/Assess, Warn, Advise, Refer, and Do-it-again), accompanied by a health warning leaflet and a smoking cessation information booklet.
Interventions are as follows:
Chewing gum group (intervention): Participants will receive 4 packs of xylitol gum at baseline and up to 24 packs throughout the 12-week intervention. Approximately 24 reminder messages (two per week), developed based on the Love and Care Approach framework, will be delivered via instant messaging to reinforce motivation and adherence.
Unassisted quitting group (control): Participants will receive brief advice only at baseline.
To explore user experience and acceptability, semi-structured qualitative interviews will be conducted with 20 intervention-group participants to understand their perceptions and experiences with xylitol gum use.
The primary outcome is biochemically validated smoking abstinence at 6 months, defined as exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/mL.
- Conditions
- Smoking Cessation, Health Promotion
- Being tested
- Brief smoking cessation advice, Warning leaflet, Self-help smoking cessation booklet, 4-week xylitol gum intervention, Instructional leaflet
- Keywords
- Xylitol gum, Smoking cessation, Hybrid type 1 effectiveness-implementation design
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief smoking cessation adviceBehavioural
Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).
Warning leafletBehavioural
The warning leaflet contains pictorial depictions of the adverse health effects of smoking.
Self-help smoking cessation bookletBehavioural
The self-help smoking cessation booklet includes commonly used smoking cessation strategies.
4-week xylitol gum interventionBehavioural
Participants in the intervention group will receive 4 packs of xylitol gum (approximately US $2 per pack) at baseline and will be encouraged to use it when they experience cravings.
Instructional leafletBehavioural
The instructional leaflet includes the potential benefits of xylitol gum for smoking cessation, recommended timing and dosage for use, and appropriate disposal of used gum.
12-week instant message supportBehavioural
Approximately 24 reminder messages (two per week), developed based on the Love and Care Approach framework, will be delivered over the 12-week period to reinforce motivation and adherence.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants assigned to the intervention group will receive a 3-month behavioral intervention comprising a 4-week xylitol gum aligned with 12 weeks of instant reminder message support. Receives: Behavioral: Brief smoking cessation advice; Behavioral: Warning leaflet; Behavioral: Self-help smoking cessation booklet; Behavioral: 4-week xylitol gum intervention; Behavioral: Instructional leaflet; Behavioral: 12-week instant message support |
| Control group | Active comparator | Participants in the control group will receive brief SC advice and a SC information booklet at baseline, which had been routinely used in our previous trials. Receives: Behavioral: Brief smoking cessation advice; Behavioral: Warning leaflet; Behavioral: Self-help smoking cessation booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated smoking abstinence
Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml
Measured: 6-month follow-up
Secondary outcomes (4)
Biochemically validated smoking abstinence
Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml
Measured: 3-month follow-up
Self-report 7-day point-prevalence abstinence
By asking a question, "Have you smoked (even a puff) during the past 7 days?"
Measured: 1-, 3-, and 6-months follow-ups
Smoking reduction
Defined by a reduction of≥50% in daily cigarette consumption compared with baseline.
Measured: 1-, 3-, and 6-months follow-ups
Quit attempt
By asking a question, "Have you attempted to stop smoking completely for at least 24 hours in the past 7 days?"
Measured: 1-, 3-, and 6-months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start24 Nov 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Wang, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240545
- Sponsor's protocol ID
- Chew 2 quit
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07240545
- Acronym / sponsor ID
- Chew 2 quit
- Conditions
- Smoking Cessation, Health Promotion
- Keywords
- Xylitol gum, Smoking cessation, Hybrid type 1 effectiveness-implementation design
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 24 Nov 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Nov 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 goal of this clinical trial is to learn if 4-week xylitol gum intervention works to promote smoking cessation in daily smokers. It will also learn about the feasibility and acceptability of using xylitol gum. The main questions it aims to answer are:
（1）Does xylitol gum help to reduce cigarette consumption and promote smoking cessation?
Researchers will compare 4-week xylitol gum intervention to the brief advice to see if xylitol gum works to promote smoking cessation.
Participants in the intervention group will receive a 3-month behavioral intervention comprising a 4-week xylitol gum aligned with 12 weeks of instant reminder message support.
Detailed description
This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a proactive smoking cessation intervention using xylitol chewing gum. Eligible participants will be Hong Kong residents aged ≥18 years who (1) have smoked at least one cigarette per day in the past 3 months; (2) can communicate in Cantonese (including reading Chinese); (3) express an intention to quit or reduce smoking; (4) are able to use instant messaging tools (e.g., WhatsApp); and (5) regularly chew gum or are willing to use chewing gum for smoking reduction.
A total of 134 participants will be recruited from community settings, including public housing estates across Hong Kong's 18 districts, community and university smoking hotspots, referrals from other smoking cessation programmes, and social media promotions (Facebook and Instagram). The study will adopt a hybrid type I effectiveness-implementation design. Participants will be followed up at 1, 3, and 6 months post-enrolment via telephone, following CONSORT guidelines, to assess cigarette reduction and cessation outcomes.
All participants will receive brief smoking cessation advice at baseline using the AWARD model (Ask/Assess, Warn, Advise, Refer, and Do-it-again), accompanied by a health warning leaflet and a smoking cessation information booklet.
Interventions are as follows:
Chewing gum group (intervention): Participants will receive 4 packs of xylitol gum at baseline and up to 24 packs throughout the 12-week intervention. Approximately 24 reminder messages (two per week), developed based on the Love and Care Approach framework, will be delivered via instant messaging to reinforce motivation and adherence.
Unassisted quitting group (control): Participants will receive brief advice only at baseline.
To explore user experience and acceptability, semi-structured qualitative interviews will be conducted with 20 intervention-group participants to understand their perceptions and experiences with xylitol gum use.
The primary outcome is biochemically validated smoking abstinence at 6 months, defined as exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/mL.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Brief smoking cessation advice, Behavioral: Warning leaflet, Behavioral: Self-help smoking cessation booklet, Behavioral: 4-week xylitol gum intervention, Behavioral: Instructional leaflet, Behavioral: 12-week instant message supportParticipants assigned to the intervention group will receive a 3-month behavioral intervention comprising a 4-week xylitol gum aligned with 12 weeks of instant reminder message support. |
| Control group | Active comparator | Behavioral: Brief smoking cessation advice, Behavioral: Warning leaflet, Behavioral: Self-help smoking cessation bookletParticipants in the control group will receive brief SC advice and a SC information booklet at baseline, which had been routinely used in our previous trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Residents of Hong Kong aged 18 or above who smoke at least 1 cigarette per day over the past 3 months
- Have the habit of chewing gum or are willing to use chewing gum
- Can communicate in Cantonese (including reading Chinese)
- Express an intention to quit or reduce smoking
- Capable of using instant messaging tools (e.g., WhatsApp, WeChat) for communication
Key exclusion criteria (2 listed)
- Have communication barriers (either physical or cognitive)
- Currently participating in other smoking cessation programs or services
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 |
|---|---|---|
| Brief smoking cessation adviceBrief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again). | Behavioural | Control group, Intervention group |
| Warning leafletThe warning leaflet contains pictorial depictions of the adverse health effects of smoking. | Behavioural | Control group, Intervention group |
| Self-help smoking cessation bookletThe self-help smoking cessation booklet includes commonly used smoking cessation strategies. | Behavioural | Control group, Intervention group |
| 4-week xylitol gum interventionParticipants in the intervention group will receive 4 packs of xylitol gum (approximately US $2 per pack) at baseline and will be encouraged to use it when they experience cravings. | Behavioural | Intervention group |
| Instructional leafletThe instructional leaflet includes the potential benefits of xylitol gum for smoking cessation, recommended timing and dosage for use, and appropriate disposal of used gum. | Behavioural | Intervention group |
| 12-week instant message supportApproximately 24 reminder messages (two per week), developed based on the Love and Care Approach framework, will be delivered over the 12-week period to reinforce motivation and adherence. | Behavioural | Intervention group |
Primary outcome
Biochemically validated smoking abstinence
Time frame: 6-month follow-up
Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml
4 secondary outcomes
Biochemically validated smoking abstinence
Time frame: 3-month follow-up
Self-report 7-day point-prevalence abstinence
Time frame: 1-, 3-, and 6-months follow-ups
Smoking reduction
Time frame: 1-, 3-, and 6-months follow-ups
Quit attempt
Time frame: 1-, 3-, and 6-months follow-ups
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 21 Nov 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.
Man Ping Wang, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief smoking cessation advice, Warning leaflet and Self-help smoking cessation booklet in people with Smoking Cessation and Health Promotion, 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 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: opening soon, as of the sponsor's last update on 21 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 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 Mengyao Li, Mphil (+852 6851 8462, lmy0814@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 smoking abstinence (time frame: 6-month follow-up). 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 21 Nov 2025.