Tobacco CessationNCT07098065
Health Warnings and Counseling for Smoking Cessation
A study testing Graphical health warnings and Graphical health warnings plus pharmacist-led counselling in people with Tobacco Cessation and Health Warning Label, run by Hitotsubashi University at 1 site in Bangladesh.
Trial summary
Tobacco use remains persistently high across South Asia, despite numerous public health efforts, and continues to significantly contribute to the burden of non-communicable diseases (NCDs) such as cardiovascular disease, hypertension, diabetes, and stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tobacco Cessation, Health Warning Label, Hypertension
- What is being tested?
- Graphical health warnings and Graphical health warnings plus pharmacist-led counselling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Feb 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and older
- Adults (≥18 years) who are current smokers (daily or occasional) and regular visitors to participating pharmacies.
- Permanent resident of the study area,
- Access to mobile phone
- Able to operate smartphone or tablet.
Who cannot join
- Without pregnancy and lactation
- Without cognitive or psychiatric conditions,
- Without severe medical conditions,
- Participation in other studies, and inability to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Global Public Health Research Foundation
Dhaka
Kanok Ahammed
About this study
Official title: Health Warnings and Counseling at Primary Health Care Centers for Smoking Cessation and NCD Prevention: A Randomized Controlled Trial in Bangladesh and Pakistan
Tobacco use remains persistently high across South Asia, despite numerous public health efforts, and continues to significantly contribute to the burden of non-communicable diseases (NCDs) such as cardiovascular disease, hypertension, diabetes, and stroke. Community pharmacists-widely accessible and trusted within their communities-are an underutilized resource for delivering public health interventions. Graphic health warnings (GHWs), recommended by the World Health Organization (WHO), have been shown to promote smoking cessation, but are rarely paired with personalized counseling by healthcare providers.
This study aims to evaluate both the effectiveness and cost-effectiveness of integrating GHWs with pharmacist-led personalized counseling at primary healthcare pharmacies in Bangladesh and Pakistan. A cluster randomized controlled trial (RCT) will be conducted, enrolling 3,240 adult participants in Bangladesh and ~160 participants in Pakistan (for feasibility study) from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW only (distribution of printed booklets); (2) GHW + counseling (pharmacist-led counselling sessions based on booklets at baseline and six months, with monthly SMS reminders); or (3) standard care (usual pharmacy services with no additional materials).
The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. The primary outcome is self-reported 7-day point prevalence abstinence at 12 months (validated where feasible). Secondary outcomes include reduction in cigarettes per day, quit attempts, readiness to quit, awareness of tobacco harms, diet and physical activity scores, quality of life, blood pressure control among hypertensive participants, and cost-effectiveness. Feasibility outcomes in Pakistan include recruitment rate, participant retention, intervention fidelity and acceptability. Bayesian statistical models will be used to assess efficacy, and economic evaluations will determine the cost-effectiveness of the interventions. The findings aim to inform scalable public health strategies for tobacco control and NCD prevention in resource-limited settings.
- Being tested
- Graphical health warnings, Graphical health warnings plus pharmacist-led counselling, Routine pharmacy services (no intervention)
- Keywords
- Tobacco cessation, Graphic health warnings (GHWs), Non-communicable diseases (NCDs), Cluster randomized controlled trial (RCT), Pharmacist-led counseling
- Medical subject headings
- Tobacco Use Cessation, Hypertension, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graphical health warningsBehavioural
This group will receive only graphical health warnings (GHWs) featuring images proposed by the Bangladesh Tobacco Control Cell, explicitly illustrating smoking-related harms, such as mouth diseases, damaged teeth and gums, lung diseases and cancer, heart diseases and cardiovascular damage, and throat and oral cancer. Additionally, these warnings will clearly highlight the benefits of quitting smoking-including improved overall health, reduced disease risks, financial savings, and enhanced quality of life-as well as practical cessation techniques. Participants will receive these GHW materials at baseline and again at the six-month follow-up to reinforce these critical health messages; however, this intervention group will not receive any counselling services. Monthly SMS reminders will also be sent to participants, prompting them to review the GHW leaflet and reinforcing the negative health impacts of smoking and the benefits of quitting.
Graphical health warnings plus pharmacist-led counsellingBehavioural
Participants in this group will receive graphical health warnings (GHWs) featuring Bangladesh Tobacco Control Cell-approved images clearly depicting smoking-related harms (e.g., mouth diseases, damaged teeth and gums, lung cancer, heart disease, and oral cancer). Additionally, they will receive personalized counselling from community pharmacists, focused on the specific health and financial benefits of quitting, practical cessation techniques, strategies for overcoming barriers, and relapse prevention. This combined intervention will be provided at baseline and reinforced at a six-month follow-up. Monthly SMS reminders will also be sent, reinforcing key messages on the harmful effects of smoking and benefits of cessation.
Routine pharmacy services (no intervention)Other
Participants in this group will receive only routine pharmacy services based on standard pharmacy practice guidelines applicable in each country. They will not receive any additional graphical health warnings or counselling interventions. Outcomes will be assessed at baseline, 6 months, and 12 months, consistent with the intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| GHW-only intervention | Experimental | This group will receive only graphical health warnings (GHWs) featuring images proposed by the Bangladesh Tobacco Control Cell, explicitly illustrating smoking-related harms, such as mouth diseases, damaged teeth and gums, lung diseases and cancer, heart diseases and cardiovascular damage, and throat and oral cancer. Additionally, these warnings will clearly highlight the benefits of quitting smoking-including improved overall health, reduced disease risks, financial savings, and enhanced quality of life-as well as practical cessation techniques. Participants will receive these GHW materials at baseline and again at the six-month follow-up to reinforce these critical health messages; however, this intervention group will not receive any counselling services. Monthly SMS reminders will also be sent to participants, prompting them to review the GHW leaflet and reinforcing the negative health impacts of smoking and the benefits of quitting. Receives: Behavioral: Graphical health warnings |
| GHW plus pharmacist-led counselling | Experimental | Participants in this group will receive graphical health warnings (GHWs) featuring Bangladesh Tobacco Control Cell-approved images clearly depicting smoking-related harms (e.g., mouth diseases, damaged teeth and gums, lung cancer, heart disease, and oral cancer). Additionally, they will receive personalized counselling from community pharmacists, focused on the specific health and financial benefits of quitting, practical cessation techniques, strategies for overcoming barriers, and relapse prevention. This combined intervention will be provided at baseline and reinforced at a six-month follow-up. Monthly SMS reminders will also be sent, reinforcing key messages on the harmful effects of smoking and benefits of cessation. Receives: Behavioral: Graphical health warnings plus pharmacist-led counselling |
| Standard care control | Active comparator | Participants in this group will receive only routine pharmacy services based on standard pharmacy practice guidelines applicable in each country. They will not receive any additional graphical health warnings or counselling interventions. Outcomes will be assessed at baseline, 6 months, and 12 months, consistent with the intervention groups. Receives: Other: Routine pharmacy services (no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported 7-day point prevalence abstinence
The primary outcome is self-reported 7-day point prevalence abstinence at 12 months. Will be measured by percentage of participants who report smoking cessation
Measured: 6 months and 12 months post-intervention.
Secondary outcomes (12)
Change in Cigarette Consumption
Change in the number of cigarettes smoked per day among participants from baseline.medication adherence.
Measured: 6 and 12 months.
Quit Attempts
Proportion of participants reporting at least one quit attempt during the follow-up period.medication adherence.
Measured: 6 and 12 months.
Readiness to Quit Smoking
Change in participants' readiness to quit smoking, assessed using stages of change or validated readiness scales.
Measured: 6 and 12 months.
Improvement in Knowledge About Smoking Harms
Percentage increase in correct responses to questions on the health effects of smoking.
Measured: 6 and 12 months.
Improved Hypertension Management
Proportion of hypertensive participants achieving BP <140/90 mmHg or reporting medication adherence.
Measured: 6 and 12 months.
Improved Diabetes Management
Proportion of participants with diabetes reporting glucose monitoring, medication adherence, or controlled HbA1c (if available).
Measured: 6 and 12 months.
Change in Quality-Adjusted Life Years (QALYs)
Incremental QALYs gained from baseline to 12 months, based on health utility measures (e.g., EQ-5D).stroke, cardiac events).
Measured: 6 and 12 months.
Hospital Admissions
Number of participants reporting hospital admission related to NCDs (e.g., hypertension, stroke, cardiac events).
Measured: 6 and 12 months.
Increase in Physical Activity
Increase in days per week with at least 30 minutes of moderate activity.
Measured: 6 and 12 months.
Diet Quality
Change in dietary behaviour assessed using a composite diet quality score based on frequency and type of food consumption (e.g. fruit, vegetables, processed foods).
Measured: 6 and 12 months.
Incremental Cost-Effectiveness Ratio
Cost per QALY gained comparing intervention arms to control.
Measured: At 12 months.
Image-Based Biomarker Assessment (Exploratory Secondary Outcome)
Quantitative features extracted from facial photographs, eye photographs, and chest X-rays will be analyzed to examine associations with smoking exposure, blood pressure, and cardiometabolic risk markers.
Measured: Time Frame: Baseline and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Feb 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitotsubashi University
- Sponsor type
- University, hospital or other
- Collaborators
- Global Public Health Research Foundation
- Responsible party
- Principal investigator, Md. Mizanur Rahman, PhD, Hitotsubashi University
- Investigators
- Md. Mizanur Rahman, Principal investigator, Hitotsubashi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098065
- Sponsor's protocol ID
- GHW Trial for smokers
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Warnings and Counseling at Primary Health Care Centers for Smoking Cessation and NCD Prevention: A Randomized Controlled Trial in Bangladesh and Pakistan
- ClinicalTrials.gov ID
- NCT07098065
- Acronym / sponsor ID
- GHW Trial for smokers
- Keywords
- Tobacco cessation, Graphic health warnings (GHWs), Non-communicable diseases (NCDs), Cluster randomized controlled trial (RCT), Pharmacist-led counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- Hitotsubashi UniversityUniversity, hospital or other
- Collaborators
- Global Public Health Research Foundation
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 Aug 2025 (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.
Tobacco use remains persistently high across South Asia, despite numerous public health efforts, and continues to significantly contribute to the burden of non-communicable diseases (NCDs) such as cardiovascular disease, hypertension, diabetes, and stroke. Community pharmacists-widely accessible and trusted within their communities-are an underutilized resource for delivering public health interventions. Graphic health warnings (GHWs), recommended by the World Health Organization (WHO), have been shown to promote smoking cessation, but are rarely paired with personalized counseling by healthcare providers.
This study aims to evaluate both the effectiveness and cost-effectiveness of integrating GHWs with pharmacist-led personalized counseling at primary healthcare pharmacies in Bangladesh and Pakistan. A cluster randomized controlled trial (RCT) will be conducted, enrolling 3,240 adult participants in Bangladesh and ~160 participants in Pakistan (for feasibility study) from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW only (distribution of printed booklets); (2) GHW + counseling (pharmacist-led counselling sessions based on booklets at baseline and six months, with monthly SMS reminders); or (3) standard care (usual pharmacy services with no additional materials).
The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. The primary outcome is self-reported 7-day point prevalence abstinence at 12 months (validated where feasible). Secondary outcomes include reduction in cigarettes per day, quit attempts, readiness to quit, awareness of tobacco harms, diet and physical activity scores, quality of life, blood pressure control among hypertensive participants, and cost-effectiveness. Feasibility outcomes in Pakistan include recruitment rate, participant retention, intervention fidelity and acceptability. Bayesian statistical models will be used to assess efficacy, and economic evaluations will determine the cost-effectiveness of the interventions. The findings aim to inform scalable public health strategies for tobacco control and NCD prevention in resource-limited settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GHW-only intervention | Experimental | Behavioral: Graphical health warningsThis group will receive only graphical health warnings (GHWs) featuring images proposed by the Bangladesh Tobacco Control Cell, explicitly illustrating smoking-related harms, such as mouth diseases, damaged teeth and gums, lung diseases and cancer, heart diseases and cardiovascular damage, and throat and oral cancer. Additionally, these warnings will clearly highlight the benefits of quitting smoking-including improved overall health, reduced disease risks, financial savings, and enhanced quality of life-as well as practical cessation techniques. Participants will receive these GHW materials at baseline and again at the six-month follow-up to reinforce these critical health messages; however, this intervention group will not receive any counselling services. Monthly SMS reminders will also be sent to participants, prompting them to review the GHW leaflet and reinforcing the negative health impacts of smoking and the benefits of quitting. |
| GHW plus pharmacist-led counselling | Experimental | Behavioral: Graphical health warnings plus pharmacist-led counsellingParticipants in this group will receive graphical health warnings (GHWs) featuring Bangladesh Tobacco Control Cell-approved images clearly depicting smoking-related harms (e.g., mouth diseases, damaged teeth and gums, lung cancer, heart disease, and oral cancer). Additionally, they will receive personalized counselling from community pharmacists, focused on the specific health and financial benefits of quitting, practical cessation techniques, strategies for overcoming barriers, and relapse prevention. This combined intervention will be provided at baseline and reinforced at a six-month follow-up. Monthly SMS reminders will also be sent, reinforcing key messages on the harmful effects of smoking and benefits of cessation. |
| Standard care control | Active comparator | Other: Routine pharmacy services (no intervention)Participants in this group will receive only routine pharmacy services based on standard pharmacy practice guidelines applicable in each country. They will not receive any additional graphical health warnings or counselling interventions. Outcomes will be assessed at baseline, 6 months, and 12 months, consistent with the intervention groups. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 and older
- Adults (≥18 years) who are current smokers (daily or occasional) and regular visitors to participating pharmacies.
- Permanent resident of the study area,
- Access to mobile phone
- Able to operate smartphone or tablet.
Key exclusion criteria (4 listed)
- Without pregnancy and lactation
- Without cognitive or psychiatric conditions,
- Without severe medical conditions,
- Participation in other studies, and inability to consent.
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 |
|---|---|---|
| Graphical health warningsThis group will receive only graphical health warnings (GHWs) featuring images proposed by the Bangladesh Tobacco Control Cell, explicitly illustrating smoking-related harms, such as mouth diseases, damaged teeth and gums, lung diseases and cancer, heart diseases and cardiovascular damage, and throat and oral cancer. Additionally, these warnings will clearly highlight the benefits of quitting smoking-including improved overall health, reduced disease risks, financial savings, and enhanced quality of life-as well as practical cessation techniques. Participants will receive these GHW materials at baseline and again at the six-month follow-up to reinforce these critical health messages; however, this intervention group will not receive any counselling services. Monthly SMS reminders will also be sent to participants, prompting them to review the GHW leaflet and reinforcing the negative health impacts of smoking and the benefits of quitting. | Behavioural | GHW-only intervention |
| Graphical health warnings plus pharmacist-led counsellingParticipants in this group will receive graphical health warnings (GHWs) featuring Bangladesh Tobacco Control Cell-approved images clearly depicting smoking-related harms (e.g., mouth diseases, damaged teeth and gums, lung cancer, heart disease, and oral cancer). Additionally, they will receive personalized counselling from community pharmacists, focused on the specific health and financial benefits of quitting, practical cessation techniques, strategies for overcoming barriers, and relapse prevention. This combined intervention will be provided at baseline and reinforced at a six-month follow-up. Monthly SMS reminders will also be sent, reinforcing key messages on the harmful effects of smoking and benefits of cessation. | Behavioural | GHW plus pharmacist-led counselling |
| Routine pharmacy services (no intervention)Participants in this group will receive only routine pharmacy services based on standard pharmacy practice guidelines applicable in each country. They will not receive any additional graphical health warnings or counselling interventions. Outcomes will be assessed at baseline, 6 months, and 12 months, consistent with the intervention groups. | Other | Standard care control |
Primary outcome
Self-reported 7-day point prevalence abstinence
Time frame: 6 months and 12 months post-intervention.
The primary outcome is self-reported 7-day point prevalence abstinence at 12 months. Will be measured by percentage of participants who report smoking cessation
12 secondary outcomes
Change in Cigarette Consumption
Time frame: 6 and 12 months.
Quit Attempts
Time frame: 6 and 12 months.
Readiness to Quit Smoking
Time frame: 6 and 12 months.
Improvement in Knowledge About Smoking Harms
Time frame: 6 and 12 months.
Improved Hypertension Management
Time frame: 6 and 12 months.
Improved Diabetes Management
Time frame: 6 and 12 months.
Change in Quality-Adjusted Life Years (QALYs)
Time frame: 6 and 12 months.
Hospital Admissions
Time frame: 6 and 12 months.
Increase in Physical Activity
Time frame: 6 and 12 months.
Diet Quality
Time frame: 6 and 12 months.
Incremental Cost-Effectiveness Ratio
Time frame: At 12 months.
Image-Based Biomarker Assessment (Exploratory Secondary Outcome)
Time frame: Time Frame: Baseline and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Md. Mizanur Rahman principal investigator
Hitotsubashi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graphical health warnings and Graphical health warnings plus pharmacist-led counselling in people with Tobacco Cessation and Health Warning Label, run by Hitotsubashi University at 1 site in Bangladesh.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Md. Mizanur Rahman, PhD (+818035463610, mizanurrub78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 7-day point prevalence abstinence (time frame: 6 months and 12 months post-intervention.). 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 14 Apr 2026.