Xylitol Gum for Promoting Smoking Cessation

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation; Health Promotion

• Registration Number: NCT07240545
• Lead Sponsor: The University of Hong Kong

Brief 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. 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 Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-16
• Study First Submitted QC: 2025-11-16
• Last Update Submitted: 2025-11-16
• Study First Posted: 2025-11-21
• Last Update Posted: 2025-11-21
• Study Start: 2025-11-24
• Primary Completion: 2026-02-28
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• 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

Exclusion Criteria

• Have communication barriers (either physical or cognitive)
• Currently participating in other smoking cessation programs or services

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically validated smoking abstinence	6-month follow-up	Verified by exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml

Secondary Outcome Measures

Name	Time	Method
Quit attempt	1-, 3-, and 6-months follow-ups	By asking a question, "Have you attempted to stop smoking completely for at least 24 hours in the past 7 days?"
Biochemically validated smoking abstinence	3-month follow-up	Verified by exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml
Self-report 7-day point-prevalence abstinence	1-, 3-, and 6-months follow-ups	By asking a question, "Have you smoked (even a puff) during the past 7 days?"
Smoking reduction	1-, 3-, and 6-months follow-ups	Defined by a reduction of≥50% in daily cigarette consumption compared with baseline.

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong