Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief smoking cessation advice | Behavioral | Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically validated smoking abstinence | Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically validated smoking abstinence | Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml | 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?" |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pieces of xylitol gum used | Total daily count used during the intervention period | 1- and 3-month follow-ups |
| Frequency of using xylitol gum | Average number of chewing episodes per day. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengyao Li, Mphil | Contact | +852 6851 8462 | lmy0814@connect.hku.hk | |
| Man Ping Wang, PhD | Contact | +852 3917 6636 | mpwang@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Man Ping Wang, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, The University of Hong Kong | Hong Kong | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Warning leaflet | Behavioral | The warning leaflet contains pictorial depictions of the adverse health effects of smoking. |
|
| Self-help smoking cessation booklet | Behavioral | The self-help smoking cessation booklet includes commonly used smoking cessation strategies. |
|
| 4-week xylitol gum intervention | Behavioral | 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 leaflet | Behavioral | 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 support | Behavioral | 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. |
|
| 1-, 3-, and 6-months follow-ups |
| Smoking reduction | Defined by a reduction of≥50% in daily cigarette consumption compared with baseline. | 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?" | 1-, 3-, and 6-months follow-ups |
| 1- and 3-month follow-ups |
| Duration of use | Average time spent chewing each piece. | 1- and 3-month follow-ups |