Health Warnings and Counseling for Smoking Cessation

Hitotsubashi University

Status: Enrolling

Conditions: Hypertension; Non Communicable Chronic Diseases; Health Warning Label; Tobacco Cessation

Treatments: Other: Routine pharmacy services (no intervention); Behavioral: Graphical health warnings plus pharmacist-led counselling; Behavioral: Graphical health warnings

Study type: Interventional

Funder types: Other

Identifiers

NCT07098065

GHW Trial for smokers

Details and patient eligibility

About

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 5,052 adult participants in each country from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW-only intervention, (2) combined GHW and pharmacist-led counseling, or (3) standard care (control).

The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. Primary outcomes are smoking cessation rates and blood pressure reduction. Secondary outcomes include improved hypertension and diabetes management, medication adherence, lifestyle modification, reduced hospitalizations and mortality, and incremental cost-effectiveness. 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.

Enrollment: 5,052 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 and older
• Regular pharmacy visitors who currently smoke or have medically diagnosed hypertension without organ damage
• Permanent resident of the study area,
• Access to mobile phone
• Able to operate smartphone or tablet.

Exclusion criteria

• Without pregnancy and lactation
• Without cognitive or psychiatric conditions,
• Without severe medical conditions,
• Participation in other studies, and inability to consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,052 participants in 3 patient groups

GHW-only intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Graphical health warnings

GHW plus pharmacist-led counselling

Experimental group

Description:

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.

Treatment:

Behavioral: Graphical health warnings plus pharmacist-led counselling

Standard care control

Active Comparator group

Description:

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.

Treatment:

Other: Routine pharmacy services (no intervention)