- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07649018
Gen AI Powered Behavioral Support Plus Chewing Gum Intervention for Construction Workers Who Smoke: A Pragmatic, Pilot, Cluster Randomized Controlled Trial
Build to Quit 「築建無煙」: Gen AI Powered Behavioral Support Plus Chewing Gum Intervention for Construction Workers Who Smoke: A Pragmatic, Pilot, Cluster Randomized Controlled Trial
The goal of this pilot trial is to learn if 1-week NRT sampling, 3-week chewing gum, and 12-week chatbot-delivered instant messaging support works to help smoking cessation in construction workers who smoke. It will also learn about the feasibility, acceptability, and preliminary effectiveness of delivering the comprehensive intervention in construction settings. The main questions it aims to answer are:
- Will the integrated intervention, comprising NRT sampling, chewing gum, and chatbot-delivered instant messaging support, show feasibility, acceptability, and appropriateness for delivery in construction worksite settings?
- Will participants who receive the comprehensive intervention have a higher validated abstinence rate than those who receive NRT sampling alone?
Researchers will compare the integrated intervention, comprising NRT sampling, chewing gum, and chatbot-delivered instant messaging support, to the standard care group (NRT sampling alone) to see if the integrated intervention works to promote smoking cessation.
Participants in the intervention group will receive:
- AWARD advice and brief video
- 1-week NRT sampling
- 3-week chewing gum
- 12-week chatbot-based instant messaging support (via WhatsApp)
연구 개요
상태
정황
상세 설명
Hong Kong has achieved a sustained reduction in daily cigarette smoking, from 23.3% in the early 1980s to 8.5% in 2025. However, the current prevalence remains above the Government's Towards 2025 target of 7.8%, indicating the need for continued and targeted cessation efforts. The construction industry represents a particularly important setting for intervention, as recent legislative amendments to designate construction sites as no-smoking areas have further strengthened the policy basis for promoting smoke-free worksites.
Construction workers (CWs) are a high-priority population for smoking cessation because they have consistently higher smoking prevalence than many other occupational groups and the general population. In Hong Kong, a workplace health study found that 45% of construction workers were daily smokers, nearly twice the prevalence among office clerks/professionals. For CWs, smoking may compound existing occupational health risks by increasing susceptibility to respiratory and cardiovascular diseases in a physically demanding and dust-exposed work environment.
This study proposes a comprehensive worksite-targeted smoking cessation intervention model for CWs who smoke in Hong Kong, integrating NRT sampling, chewing gum support, and chatbot-delivered instant messaging. NRT is an evidence-based pharmacotherapy for reducing nicotine withdrawal symptoms and supporting smoking abstinence, and has been widely used in community-based cessation interventions. For CWs, short-term NRT sampling may provide immediate access to evidence-based pharmacological support, reduce early withdrawal symptoms, and lower the initial barrier to treatment uptake in a worksite setting. Chewing gum may complement NRT sampling by serving as a low-cost behavioral substitute for smoking, particularly by replacing the hand-to-mouth and oral routines associated with cigarette use. Chatbot-delivered instant messaging support can further extend the intervention beyond the worksite by providing 24/7 support, reminders for NRT and chewing gum use, and real-time assistance during cravings or high-risk smoking situations.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Man Ping Wang, PhD
- 전화번호: +852 3917 6636
- 이메일: mpwang@hku.hk
연구 연락처 백업
- 이름: Mengyao Li, Mphil
- 전화번호: +852 6851 8462
- 이메일: lmy0814@connect.hku.hk
연구 장소
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Hong Kong
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Hong Kong, Hong Kong, 홍콩, 999077
- Hong Kong Council on Smoking and Health (COSH)
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연락하다:
- Fung Wong
- 전화번호: +852 2180 5186
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부수사관:
- Tai Hing Lam, MD
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부수사관:
- Tzu Tsun Luk, PhD
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부수사관:
- Xiaoyun Xie, MPH
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부수사관:
- Mengyao Li, Mphil
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부수사관:
- Ziqiu Guo, PhD
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부수사관:
- Yilan Wu, Mphil
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Smoke at least one cigarette per day in the preceding 3-month
- Able to communicate in Cantonese (including reading and writing Chinese)
- Saliva cotinine 30 ng/ml or above
- Intent to quit / reduce smoking
- Have instant messaging tool (WhatsApp) installed
- Able to use instant messaging tool (e.g., WhatsApp) for communication.
Exclusion Criteria:
- Smokers who are participating in other smoking cessation programmes
- Smokers who are using any smoking cessation medication
- Smokers who are presenting with the following oral diseases, including recent oral surgery or tooth extraction, unstable dentures, significant tooth mobility or advanced periodontal disease, temporomandibular pain or dysfunction, or painful oral mucosal lesions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 개입 그룹
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내용은 금연의 장점, 흡연과 질병, 금연방법, 금단증상 대처방법, 금연선언 등에 대한 정보를 담고 있다.
수상 조언에는 흡연 이력에 대한 질문, 고위험에 대한 경고, 종료하라는 조언, 흡연자를 흡연 중단 서비스 (추천 카드 포함)를 참조하고 다시 수행하는 것이 포함됩니다.
내용은 간단한 정보와 기존 금연 서비스, 연락 방법, 동기 부여 정보 및 강력한 지원 메시지 또는 슬로건의 하이라이트로 구성됩니다.
The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and secondhand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking.
Participants in both group will receive a 1-week supply of free nicotine gum (2 mg or 4 mg).
The dosage of nicotine gum will be guided by participants' daily cigarette consumption, in accordance with recommendations from the Department of Health.
Research assistants will explain the benefits of NRT for smoking cessation, provide instructions on the correct use of nicotine gum, encourage participants to continue using nicotine gum after completing the free sample where appropriate, and advise participants to reduce smoking or make a quit attempt when using NRT.
Participants in the intervention group will receive 6 packs of chewing gum at baseline (2 packs per week).
Chewing gum will be presented as a practical strategy to replace the hand-to-mouth and oral routines associated with smoking, particularly during work breaks, after meals, in other smoking-related situations at construction sites, or when participants are unwilling to use nicotine gum.
Participants in the intervention group will receive 12 weeks of instant messaging support delivered by the LLM-based chatbot accessible via WhatsApp platform.
The chatbot, powered by Claude model (or more advanced model available) using prompt-engineering and agent-based techniques, will deliver theory-based and structured intervention alongside freeform, on-demand support.
The structured intervention session deploys the 5As model (Ask, Advise, Assess, Assist, and Arrange follow-up) and 5Rs model (Relevance, Risks, Rewards, Roadblocks, Repetition), as used in our previous telephone-counselling trials and recommended by WHO for brief SC intervention.
Participants in both groups will receive a brief motivational video (15-second) via WhatsApp.
The video will feature a construction worker who successfully quit smoking in our previous trial, providing a relatable peer role model for participants.
The video will welcome participants to the programme, encourage them to make a quit attempt, and promote early use of nicotine gum as a practical strategy for managing cravings and supporting smoking cessation.
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활성 비교기: 대조군
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내용은 금연의 장점, 흡연과 질병, 금연방법, 금단증상 대처방법, 금연선언 등에 대한 정보를 담고 있다.
수상 조언에는 흡연 이력에 대한 질문, 고위험에 대한 경고, 종료하라는 조언, 흡연자를 흡연 중단 서비스 (추천 카드 포함)를 참조하고 다시 수행하는 것이 포함됩니다.
내용은 간단한 정보와 기존 금연 서비스, 연락 방법, 동기 부여 정보 및 강력한 지원 메시지 또는 슬로건의 하이라이트로 구성됩니다.
The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and secondhand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking.
Participants in both group will receive a 1-week supply of free nicotine gum (2 mg or 4 mg).
The dosage of nicotine gum will be guided by participants' daily cigarette consumption, in accordance with recommendations from the Department of Health.
Research assistants will explain the benefits of NRT for smoking cessation, provide instructions on the correct use of nicotine gum, encourage participants to continue using nicotine gum after completing the free sample where appropriate, and advise participants to reduce smoking or make a quit attempt when using NRT.
Participants in both groups will receive a brief motivational video (15-second) via WhatsApp.
The video will feature a construction worker who successfully quit smoking in our previous trial, providing a relatable peer role model for participants.
The video will welcome participants to the programme, encourage them to make a quit attempt, and promote early use of nicotine gum as a practical strategy for managing cravings and supporting smoking cessation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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생화학적으로 검증된 금욕
기간: 6개월 추적
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호기 CO 수준 <4ppm 및 타액 코티닌 수준 ≤30ng/ml로 정의
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6개월 추적
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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생화학적으로 검증된 금욕
기간: 3개월 추적
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호기 CO 수준 <4ppm 및 타액 코티닌 수준 ≤30ng/ml로 정의
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3개월 추적
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자체보고 된 7 일 포인트 유병률 금욕
기간: 3 개월 및 6 개월 후속 조치
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후속 조치 전 7 일 동안 퍼프를 피우지 않은 흡연자
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3 개월 및 6 개월 후속 조치
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자체보고 감소
기간: 1-, 2-, 3- 및 6 개월 후속 조치
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기준선 일일 담배 수의 50% 이상 감소로 정의
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1-, 2-, 3- 및 6 개월 후속 조치
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흡연 중단 서비스의 자체보고 된 사용
기간: 1-, 2-, 3- 및 6 개월 후속 조치
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1-, 2-, 3 개 및 6 개월 후속 조치에서 금연 서비스 사용.
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1-, 2-, 3- 및 6 개월 후속 조치
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Family well-being
기간: 3- and 6-month follow-ups
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Family well-being will be assessed using the 3H scale, which measures perceived family health, happiness, and harmony on a 0-10 scale.
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3- and 6-month follow-ups
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Perceived family happiness
기간: 3- and 6-month follow-ups
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Perceived family happiness will be measured using a single-item self-reported family happiness scale ranging from 0 to 10.
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3- and 6-month follow-ups
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment rate
기간: Baseline
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Defined as the number of participants divided by the number of eligible smokers
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Baseline
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Retention rate
기간: 1-, 2-, 3- and 6-month follow-ups
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Defined as the number of participants who completed the follow-up divided by the number of participants
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1-, 2-, 3- and 6-month follow-ups
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Chatbot usability
기간: 3-month follow-up
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Chatbot usability will be evaluated using the 11-item Bot Usability Scale (BUS), which assesses perceived effectiveness, efficiency, and satisfaction.
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3-month follow-up
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Acceptability of NRT sampling
기간: 1-, 2-, 3- and 6-month follow-ups
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Acceptability of NRT sampling will be assessed through 4 brief items (score range from 0 to10) on perceived usefulness for craving relief, perceived side effects, willingness to continue using NRT after the free sample, and overall satisfaction with the NRT gum.
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1-, 2-, 3- and 6-month follow-ups
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Acceptability of chewing gum
기간: 1-, 2-, 3- and 6-month follow-ups
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Acceptability of chewing gum will be assessed through 3 brief items (score range from 0 to 10) on perceived usefulness for behavioral substitution, perceived fit with construction worksite routines, and willingness to continue using chewing gum as a cessation aid.
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1-, 2-, 3- and 6-month follow-ups
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Self-reported adverse events
기간: 1-, 2-, 3- and 6-month follow-ups
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Self-reported adverse events related to nicotine gum and chewing gum will be assessed using a binary question: "Have you experienced any adverse events when using nicotine gum or chewing gum?"
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1-, 2-, 3- and 6-month follow-ups
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공동 작업자 및 조사자
수사관
- 수석 연구원: Man Ping Wang, PhD, The University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Build to Quit
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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