Smoking CessationNCT07432152
Developing a Community Support Program to Help People Quit Smoking.
A study testing Smoking cessation in communities in people with Smoking Cessation, run by Mahidol University at 2 sites in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking cessation in communities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesThailand
- Study dates
- 9 Feb 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Ban Nong Chan Sub-district
Chaloem Phra Kiat, Saraburi, 18240
Than Kasem Sub-district
Phra Phutthabat, Saraburi, 18120
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation in communities, Standard Care for Smoking Cessation
- Keywords
- smoking cessation, workforce, Community Health Workers, community, Digital Health
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation in communitiesOther
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.
Standard Care for Smoking CessationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation Service System in communities | Experimental | 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). Receives: Other: Smoking cessation in communities |
| Standard Care Service System | Active comparator | 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. Receives: Other: Standard Care for Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start9 Feb 2026
- Primary completion30 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-arm, cluster-randomized controlled trial (cRCT) using a parallel assignment. Randomization is performed at the community (village) level rather than the individual level to prevent "data contamination" between participants in the same neighborhood. A matched-pairs design is applied during the recruitment phase to pair communities based on socio-geographic characteristics (urban) and existing healthcare infrastructure to ensure baseline comparability. Clusters are allocated 1:1 to either the "New Normal" Smoking Cessation Service System (Intervention Arm) or Standard Care (Comparison Arm). The Intervention Arm integrates task redistribution (Village Health Volunteers as frontline), digital health (Line App-based interactive monitoring), and traditional herbal therapy (Vernonia cinerea). The study uses an Intention-to-Treat (ITT) approach for analysis. The outcome assessor and statistician are masked to group allocation to minimize bias.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Sponsor
- Investigators
- Surintorn Kalampakorn, Study chair, Department of Public Health Nursing, Faculty of Public Health, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432152
- Sponsor's protocol ID
- NRCT322425
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Smoking Cessation Service System for Communities.
- ClinicalTrials.gov ID
- NCT07432152
- Acronym / sponsor ID
- NRCT322425
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, workforce, Community Health Workers, community, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study is a two-arm, cluster-randomized controlled trial (cRCT) using a parallel assignment. Randomization is performed at the community (village) level rather than the individual level to prevent "data contamination" between participants in the same neighborhood. A matched-pairs design is applied during the recruitment phase to pair communities based on socio-geographic characteristics (urban) and existing healthcare infrastructure to ensure baseline comparability. Clusters are allocated 1:1 to either the "New Normal" Smoking Cessation Service System (Intervention Arm) or Standard Care (Comparison Arm). The Intervention Arm integrates task redistribution (Village Health Volunteers as frontline), digital health (Line App-based interactive monitoring), and traditional herbal therapy (Vernonia cinerea). The study uses an Intention-to-Treat (ITT) approach for analysis. The outcome assessor and statistician are masked to group allocation to minimize bias.
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Service System in communities | Experimental | Other: Smoking cessation in communitiesParticipants 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). |
| Standard Care Service System | Active comparator | Other: Standard Care for Smoking CessationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation in communitiesA 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. | Other | Smoking Cessation Service System in communities |
| Standard Care for Smoking CessationRoutine 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. | Other | Standard Care Service System |
Primary outcome
3-Month Successful Smoking Cessation Rate
Time frame: 3 months after the initial intervention.
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.
Coverage of Information for Decision-Making
Time frame: 3 months post-intervention.
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.
Intention to Quit rate
Time frame: Baseline and 3 months post-intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surintorn Kalampakorn study chair
Department of Public Health Nursing, Faculty of Public Health, Mahidol University, Thailand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation in communities in people with Smoking Cessation, run by Mahidol University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Month Successful Smoking Cessation Rate (time frame: 3 months after the initial intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.