Xylitol Gum for Promoting Smoking Cessation

NCT ID: NCT07240545

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation Health Promotion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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.

Group Type EXPERIMENTAL

Brief smoking cessation advice

Intervention Type BEHAVIORAL

Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).

Warning leaflet

Intervention Type BEHAVIORAL

The warning leaflet contains pictorial depictions of the adverse health effects of smoking.

Self-help smoking cessation booklet

Intervention Type BEHAVIORAL

The self-help smoking cessation booklet includes commonly used smoking cessation strategies.

4-week xylitol gum intervention

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Control group

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.

Group Type ACTIVE_COMPARATOR

Brief smoking cessation advice

Intervention Type BEHAVIORAL

Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).

Warning leaflet

Intervention Type BEHAVIORAL

The warning leaflet contains pictorial depictions of the adverse health effects of smoking.

Self-help smoking cessation booklet

Intervention Type BEHAVIORAL

The self-help smoking cessation booklet includes commonly used smoking cessation strategies.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief smoking cessation advice

Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).

Intervention Type BEHAVIORAL

Warning leaflet

The warning leaflet contains pictorial depictions of the adverse health effects of smoking.

Intervention Type BEHAVIORAL

Self-help smoking cessation booklet

The self-help smoking cessation booklet includes commonly used smoking cessation strategies.

Intervention Type BEHAVIORAL

4-week xylitol gum intervention

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.

Intervention Type BEHAVIORAL

Instructional leaflet

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.

Intervention Type BEHAVIORAL

12-week instant message support

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Wang Man-Ping

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Man Ping Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Nursing, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mengyao Li, Mphil

Role: CONTACT

+852 6851 8462

Man Ping Wang, PhD

Role: CONTACT

+852 3917 6636

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mengyao Li

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Chew 2 quit

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.