An interventional study of Brief smoking cessation advice and Warning leaflet in Smoking Cessation and Health Promotion, sponsored by The University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care
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.
304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.
This study's planned enrollment of 134 is below the median of 154 across 285 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
Behavioral: Brief smoking cessation advice · Behavioral: Warning leaflet · Behavioral: Self-help smoking cessation booklet
Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).
The warning leaflet contains pictorial depictions of the adverse health effects of smoking.
The self-help smoking cessation booklet includes commonly used smoking cessation strategies.
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.
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.
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.
Biochemically validated smoking abstinence
Verified by exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml
Time frame: 6-month follow-up
Biochemically validated smoking abstinence
Verified by exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml
Time frame: 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?"
Time frame: 1-, 3-, and 6-months follow-ups
Smoking reduction
Defined by a reduction of≥50% in daily cigarette consumption compared with baseline.
Time frame: 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?"
Time frame: 1-, 3-, and 6-months follow-ups
Number of pieces of xylitol gum used
Total daily count used during the intervention period
Time frame: 1- and 3-month follow-ups
Frequency of using xylitol gum
Average number of chewing episodes per day.
Time frame: 1- and 3-month follow-ups
Duration of use
Average time spent chewing each piece.
Time frame: 1- and 3-month follow-ups
Plan to share: No
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