An interventional study of Smoking cessation in communities and Standard Care for Smoking Cessation in Smoking Cessation, sponsored by Mahidol University. Completed at 2 sites in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Mahidol University · Not applicable, Interventional, and Health services research
Brief Summary What is the purpose of this research? The goal of this study is to test a new method to help informal workers in Thailand quit smoking. The investigators seek to determine if a community-based system using digital tools (such as the Line app) is more effective than the standard care provided by local health centers.
How will the research happen?
The investigators will divide participants into two groups:
Intervention Group: This group will receive a new support system. Trained village health volunteers (VHVs) will offer brief advice and support. Participants will also receive messages and counseling through the Line application and a telephone "Quitline" (1600).
Comparison Group: This group will receive the standard care normally provided at local health centers.
The study takes place in Saraburi, Thailand, and lasts for approximately 3 months.
Who can take part?
The study team is seeking individuals who:
Are between 18 and 60 years old.
Work in jobs without formal contracts (informal workers), such as street vendors or farmers.
Currently smoke cigarettes.
Own a smartphone with internet access.
What are the research questions?
The investigators will measure four primary outcomes after 3 months to evaluate the effectiveness of the new system:
The number of smokers who received sufficient information to decide to quit.
The number of participants who intend to quit smoking.
The number of participants who successfully quit smoking (confirmed by a breath test).
The cost and value of the program compared to the health benefits gained.
Detailed Description Background and Rationale Tobacco use remains the leading cause of preventable mortality globally, accounting for approximately 8 million deaths annually. In Thailand, smoking is the third most significant risk factor for healthy life-year loss, imposing an economic burden of 87,250 million baht (0.56% of GDP). Despite national efforts, Health Region 4-particularly Saraburi Province-exhibits some of the lowest smoking screening and cessation success rates in the nation, with 6-month quit rates as low as 0.15% to 0.00% in certain areas.
The "New Normal" era, following the COVID-19 pandemic, has highlighted the need for resilient, digitally-integrated health services. Traditional hospital-based smoking cessation clinics often fail to reach "informal workers"-a vulnerable demographic (e.g., street vendors, construction laborers, farmers) who lack formal social security, earn low wages, and face significant time and transportation barriers to accessing clinic-based care.
Study Framework
This study employs Andersen's Behavioral Model of Health Services Use (ABMHSU) to analyze and address barriers to service utilization. The model categorizes influences into three factors:
Predisposing Factors: Demographic traits, social structures, and health beliefs.
Enabling Factors: Resources such as digital literacy, family support, and community infrastructure.
Need Factors: Self-perceived health symptoms and evaluated nicotine dependence (measured via the Fagerström Test for Nicotine Dependence).
The Smoking Cessation Service System Intervention
The intervention group receives a multi-faceted community-based system developed through situation analysis and stakeholder engagement. The system is built on three core pillars:
Task Redistribution (Frontline Community Workforce): The study shifts the focus from hospital-centric care to community-led intervention. Village Health Volunteers (VHVs) act as the primary frontline, conducting household screenings and recording data via mobile applications. The Community Health Board (CHB), comprising local leaders and government officers, provides policy support and monitors progress. Professional Community Nurses serve as mentors, managing complex cases and pharmacological needs via digital consultations.
Efficient Digital Communication: To overcome accessibility barriers, the system utilizes the Line Application for two-way interactive communication. This platform facilitates:
Digital Education Prescriptions: Tailored motivational messages and knowledge sets based on the participant's stage of change.
Quitline 1600 Integration: Automated and manual links to the National Quitline for proactive counseling.
Peer Support Groups: Digital communities for social reinforcement and sharing experiences.
Integrated Behavioral and Herbal Interventions: The system combines evidence-based Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) techniques delivered through virtual platforms. Additionally, the intervention integrates Vernonia cinerea (White Flower Grass) tea as a traditional herbal therapy. Vernonia cinerea is recognized in the Thai National List of Essential Herbal Drugs for the ability to reduce nicotine cravings by altering taste perception, offering a low-cost, accessible alternative to conventional Nicotine Replacement Therapy (NRT).
Study Design and Workflow This is a cluster-randomized controlled trial (RCT) conducted at the community level to prevent data contamination.
Intervention Arm: Participants receive the comprehensive "New Normal" system including VHV home visits, Line App support, and integrated herbal/behavioral therapy.
Comparison Arm: Participants receive "Standard Care," which consists of traditional advice-giving at sub-district health promotion hospitals without the active digital follow-up or community-led task redistribution framework.
Statistical Analysis Plan Effectiveness will be analyzed using an Intention-to-Treat (ITT) approach to ensure results reflect real-world community implementation. Baseline characteristics will be compared using Chi-squared and Wilcoxon signed-rank tests. Success-defined as continuous abstinence at 6 months-will be verified through exhaled carbon monoxide (CO) monitoring using a piCO+ Smokerlyzer®. Multiple logistic regression will be used to identify significant predictors of success while controlling for confounding variables.
Summary of Changes The investigators have synthesized the technical protocols into a structured English format suitable for the "Detailed Description" field of ClinicalTrials.gov. This includes the theoretical framework (Andersen's Model), the innovative system components (Task Redistribution and Line App), and the use of Vernonia cinerea. Specific eligibility criteria and outcome measure definitions are mentioned only in context to avoid duplication with other specific modules.
304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.
This study's enrollment of 80 is below the median of 154 across 285 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm receive a multi-component smoking cessation intervention designed for the "New Normal" era. Key features include: (1) Task Redistribution: Village Health Volunteers (VHVs) act as the frontline for household screening and initial advice; (2) Digital Health: Continuous monitoring and motivational support via the Line Application and digital education prescriptions; and (3) Integrated Therapy: suggestion of traditional Thai herbal medicine (Vernonia cinerea tea) combined with behavioral techniques like Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI).
Other: Smoking cessation in communities
Participants in this arm receive the standard smoking cessation services currently available at sub-district health promotion hospitals in Thailand. This includes routine brief advice from healthcare providers when participants visit the clinic and a possible referral to hospital-based smoking cessation clinics if applicable. This arm does not include active community-level screening by VHVs, proactive digital follow-up through the Line Application, or the specific integration of the herbal intervention.
Other: Standard Care for Smoking Cessation
A multi-component community-based intervention specifically designed for informal workers. The system utilizes "Smoking cessation in communities" as its core approach, featuring three primary pillars: Task Redistribution: Village Health Volunteers (VHVs) serve as the frontline for screening and initial brief advice within households. Digital Health Integration: Utilizing the Line Application for proactive monitoring, interactive two-way communication, and "Digital Education Prescriptions" tailored to each participant's stage of change. Integrated Behavioral Therapy: Delivery of evidence-based Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) via virtual platforms and community outreach to overcome accessibility barriers.
Routine smoking cessation services are provided at sub-district health promotion hospitals according to national guidelines. This includes brief advice and potential referral to hospital clinics during patient visits, without the active community-based screening, digital follow-up via Line App, or specific herbal therapy provided in the intervention arm.
3-Month Successful Smoking Cessation Rate
Assessed using the Fagerström Test for Nicotine Dependence (FTND), a 6-item validated questionnaire. Scores range from 0 to 10; a score of 0-2 indicates very low dependence, while 8-10 indicates very high dependence, and the proportion of participants who achieve continuous abstinence from smoking for 3 months. Success is defined by self-reported 7-day point prevalence abstinence (no smoking in the last 7 days) and is biochemically verified by an exhaled carbon monoxide (CO) concentration of less than 10 ppm measured using a piCO+ Smokerlyzer® device.
Time frame: 3 months after the initial intervention.
Coverage of Information for Decision-Making
The proportion of smokers who have received comprehensive information regarding tobacco hazards and cessation benefits, as measured by the National Adult Tobacco Survey (NATS) 5-point scale. This indicator reflects the effectiveness of the community-led digital communication strategy.
Time frame: 3 months post-intervention.
Intention to Quit rate
Measured using the Motivation to Stop Scale (MTSS), which assesses the participant's stage of change. Scores range from 1 (Pre-contemplation: not thinking about quitting) to 5 (Maintenance: quit more than six months ago). A higher score indicates a higher level of motivation and readiness to quit.
Time frame: Baseline and 3 months post-intervention.
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the article (including text, tables, figures, and appendices) will be made available for sharing. This data will include smoking status, nicotine dependence scores (FTND), and biochemically verified carbon monoxide (CO) levels, ensuring that all personal identifiers are removed to protect participant confidentiality.
Supporting information: Study protocol
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Mahidol University