Developing a Community Support Program to Help People Quit Smoking.

NCT07432152 | Enrolling By Invitation DMC

• 1 other identifier: NRCT322425
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Smoking Cessation

Keywords

smoking cessation; workforce; Community Health Workers; community; Digital Health

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

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).

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.

Other: Standard Care for Smoking Cessation

Interventions

Smoking cessation in communities OTHER

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.

Smoking Cessation Service System in communities

Standard Care for Smoking Cessation OTHER

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.

Standard Care Service System

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (2)

Ban Nong Chan Sub-district

Chaloem Phra Kiat, Saraburi, 18240, Thailand

Location

Than Kasem Sub-district

Phra Phutthabat, Saraburi, 18120, Thailand

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Residence Characteristics; Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Surintorn Kalampakorn

  Department of Public Health Nursing, Faculty of Public Health, Mahidol University, Thailand

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The Statistician and the Research Analysis Team are masked to the group allocation during the statistical processing phase to minimize analysis bias. To ensure the integrity of the results, the randomization code and group assignments are kept in sealed envelopes and are not revealed to the personnel performing the analysis until all statistical tests are finalized. The statistician evaluates the primary and secondary outcomes using coded identifiers (e.g., Group A and Group B) without knowledge of which cluster received the "New Normal" system intervention. Unblinding occurs only after the final analysis is complete and the research team has reached a unanimous consensus on the interpretation of the findings. Due to the behavioral nature of the community-based intervention (use of the Line Application and Village Health Volunteer home visits), it is not possible to mask the investigators and outcome assessors during the implementation phase.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: February 9, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available starting 6 months after article publication and will remain accessible for up to 5 years.
• 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.

Locations

TH (2)