Health Warnings and Counseling for Smoking Cessation

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07098065
• Lead Sponsor: Hitotsubashi University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5052

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Verified smoking cessation rates	Baseline, 6 months, and 12 months post-intervention.	Percentage of participants who report smoking cessation
Change in Systolic Blood Pressure (SBP)	Baseline, 6 months, and 12 months.	Mean change in systolic blood pressure (mmHg) from baseline to 6 and 12 months. Changes in Blood pressure in the target intervention group (Whose SBP\<140 mmHg and DBP\<90 mmHg were in the baseline) Changes in SBP and DBP of the patients at baseline, at 12 months and 18 months post-intervention.; Changes in Blood pressure in the target intervention group (Whose SBP\<140 mmHg and DBP\<90 mmHg were in the baseline)
Change in Diastolic Blood Pressure (DBP)	Baseline, 6 months, and 12 months.	Mean change in diastolic blood pressure (mmHg) from baseline to 6 and 12 months.
Change in Quality-Adjusted Life Years (QALYs)	Baseline, 6 months, and 12 months.	Incremental QALYs gained from baseline to 12 months, based on health utility measures (e.g., EQ-5D).
Improvement in Knowledge About Smoking Harms	Baseline, 6 months, and 12 months.	Percentage increase in correct responses to questions on the health effects of smoking.

Secondary Outcome Measures

Name	Time	Method
Improved Diabetes Management	6 and 12 months.	Proportion of participants with diabetes reporting glucose monitoring, medication adherence, or controlled HbA1c (if available).
Improved Hypertension Management	6 and 12 months.	Proportion of hypertensive participants achieving BP \<140/90 mmHg or reporting medication adherence.
Hospital Admissions	6 and 12 months.	Number of participants reporting hospital admission related to NCDs (e.g., hypertension, stroke, cardiac events).
All-Cause Mortality	Up to 12 months.	Number of deaths (any cause) among enrolled participants during the study period.
Increase in Physical Activity	6 and 12 months.	Increase in days per week with at least 30 minutes of moderate activity.
Incremental Cost-Effectiveness Ratio	At 12 months.	Cost per QALY gained comparing intervention arms to control.