Health Warning Label, Hypertension, Non Communicable Chronic Diseases, Tobacco Cessation
Conditions
Keywords
Tobacco cessation, Graphic health warnings (GHWs), Non-communicable diseases (NCDs), Cluster randomized controlled trial (RCT), Pharmacist-led counseling
Brief 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. 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.
Interventions
BEHAVIORALGraphical health warnings
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.
BEHAVIORALGraphical health warnings plus pharmacist-led counselling
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.
OTHERRoutine 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.
Sponsors
Hitotsubashi University
Global Public Health Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Without pregnancy and lactation * Without cognitive or psychiatric conditions, * Without severe medical conditions, * Participation in other studies, and inability to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 7-day point prevalence abstinence | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cigarette Consumption | 6 and 12 months. | Change in the number of cigarettes smoked per day among participants from baseline.medication adherence. |
| Quit Attempts | 6 and 12 months. | Proportion of participants reporting at least one quit attempt during the follow-up period.medication adherence. |
| Readiness to Quit Smoking | 6 and 12 months. | Change in participants' readiness to quit smoking, assessed using stages of change or validated readiness scales. |
| Improvement in Knowledge About Smoking Harms | 6 and 12 months. | Percentage increase in correct responses to questions on the health effects of smoking. |
| Improved Hypertension Management | 6 and 12 months. | Proportion of hypertensive participants achieving BP \<140/90 mmHg or reporting medication adherence. |
| Improved Diabetes Management | 6 and 12 months. | Proportion of participants with diabetes reporting glucose monitoring, medication adherence, or controlled HbA1c (if available). |
| Change in Quality-Adjusted Life Years (QALYs) | 6 and 12 months. | Incremental QALYs gained from baseline to 12 months, based on health utility measures (e.g., EQ-5D).stroke, cardiac events). |
| Hospital Admissions | 6 and 12 months. | Number of participants reporting hospital admission related to NCDs (e.g., hypertension, stroke, cardiac events). |
| Increase in Physical Activity | 6 and 12 months. | Increase in days per week with at least 30 minutes of moderate activity. |
| Diet Quality | 6 and 12 months. | 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). |
| Incremental Cost-Effectiveness Ratio | At 12 months. | Cost per QALY gained comparing intervention arms to control. |
| Image-Based Biomarker Assessment (Exploratory Secondary Outcome) | Time Frame: Baseline and 12 months. | 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. |
Countries
Bangladesh
Contacts
CONTACTMd. Mizanur Rahman, PhD
PRINCIPAL_INVESTIGATORMd. Mizanur Rahman
Hitotsubashi University
Outcome results
None listed