Xylitol Gum for Promoting Smoking Cessation

NCT07240545 | Not Yet Recruiting DMC

• 1 other identifier: Chew 2 quit
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Health Promotion

Keywords

Xylitol gum; Smoking cessation; Hybrid type 1 effectiveness-implementation design

Outcome Measures

Primary Outcomes (1)

• Biochemically validated smoking abstinence

  Verified by exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml

  6-month follow-up

Secondary Outcomes (4)

• Biochemically validated smoking abstinence

  3-month follow-up

• Self-report 7-day point-prevalence abstinence

  1-, 3-, and 6-months follow-ups

• Smoking reduction

  1-, 3-, and 6-months follow-ups

• Quit attempt

  1-, 3-, and 6-months follow-ups

Other Outcomes (3)

• Number of pieces of xylitol gum used

  1- and 3-month follow-ups

• Frequency of using xylitol gum

  1- and 3-month follow-ups

• Duration of use

  1- and 3-month follow-ups

Study Arms (2)

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.

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.

Behavioral: Brief smoking cessation advice; Behavioral: Warning leaflet; Behavioral: Self-help smoking cessation booklet

Interventions

Brief smoking cessation advice BEHAVIORAL

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

Control group; Intervention group

Warning leaflet BEHAVIORAL

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

Control group; Intervention group

Self-help smoking cessation booklet BEHAVIORAL

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

Control group; Intervention group

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.

Intervention group

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.

Intervention group

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Man Ping Wang, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengyao Li, Mphil

CONTACT

+852 6851 8462; lmy0814@connect.hku.hk

Man Ping Wang, PhD

CONTACT

+852 3917 6636; mpwang@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: November 24, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)