Developing a Community Support Program to Help People Quit Smoking.

Development of the Smoking Cessation Service System for Communities.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Smoking cessation in communities; Other: Standard Care for Smoking Cessation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Saraburi
    • Chaloem Phra Kiat, Saraburi, Thailand, 18240
      • Ban Nong Chan Sub-district
    • Phra Phutthabat, Saraburi, Thailand, 18120
      • Than Kasem Sub-district

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informal worker, defined as an individual engaged in an occupation outside the formal employment system, typically lacking social security benefits or formal employment contracts (e.g., street vendors, agricultural laborers, motorcycle taxi drivers, freelancers).
• Current smoker, defined as an individual who has smoked at least one cigarette daily or non-daily within the past 30 days.
• Residing in the study area (Mueang Saraburi District) for at least 3 months prior to enrollment.
• Owns a smartphone with reliable internet access and is proficient in using mobile applications (specifically the Line Application).
• Able to speak, read, and communicate clearly in Thai.
• Willing and able to provide written informed consent to participate in the full duration of the 6-month study.

Exclusion Criteria:

• Individuals currently participating in other smoking cessation programs or concurrent clinical research studies.
• Individuals with physical or mental health conditions that may impair their ability to provide accurate information or consistently participate in digital follow-up (e.g., severe cognitive impairment, advanced terminal illness).
• Planning to relocate outside the designated study area within the next 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking Cessation Service System in communities; 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; 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.
Active Comparator: Standard Care Service System; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and 3 months post-intervention.

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: National Research Council of Thailand
• Investigators: Study Chair: Surintorn Kalampakorn, Department of Public Health Nursing, Faculty of Public Health, Mahidol University, Thailand

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: smoking cessation; community; Digital Health; Community Health Workers; workforce
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Population Characteristics; Demography; Epidemiologic Measurements; Standard of Care; Residence Characteristics
• Other Study ID Numbers: NRCT322425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available starting 6 months after article publication and will remain accessible for up to 5 years.
• IPD Sharing Access Criteria: Data will be shared with researchers whose proposed use of the data has been approved by a relevant ethical committee and who provide a methodologically sound proposal. Requests should be directed to the corresponding author at surintorn.kal@mahidol.ac.th. To gain access, data requestors will be required to sign a data access agreement to ensure data security and participant privacy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No