Набор скоро начнётся NCT07240545

Xylitol Gum for Promoting Smoking Cessation

Без фазы С лечением Smoking Cessation Health Promotion

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Brief smoking cessation advice, Warning leaflet, Self-help smoking cessation booklet, 4-week xylitol gum intervention.
Кому может быть актуально: Состояния в реестре: Smoking Cessation, Health Promotion. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Гонконг
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое Brief smoking cessation advice
Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).
Поведенческое Warning leaflet
The warning leaflet contains pictorial depictions of the adverse health effects of smoking.
Поведенческое Self-help smoking cessation booklet
The self-help smoking cessation booklet includes commonly used smoking cessation strategies.
Поведенческое 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.
Поведенческое 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.
Поведенческое 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.

Первичные конечные точки

Biochemically validated smoking abstinence [Срок оценки: 6-month follow-up]

Вторичные конечные точки (4)

Biochemically validated smoking abstinence [Срок оценки: 3-month follow-up]
Self-report 7-day point-prevalence abstinence [Срок оценки: 1-, 3-, and 6-months follow-ups]
Smoking reduction [Срок оценки: 1-, 3-, and 6-months follow-ups]
Quit attempt [Срок оценки: 1-, 3-, and 6-months follow-ups]

Критерии участия

Критерии включения

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