Health Warnings and Counseling for Smoking Cessation

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

Overview

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

• Behavioral Graphical 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 qualit
• Behavioral Graphical 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 prev
• 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.

Primary outcome measures

• Self-reported 7-day point prevalence abstinence [Time frame: 6 months and 12 months post-intervention.]

Secondary outcome measures (12)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Bangladesh · 1 center

• Global Public Health Research Foundation — Dhaka

Identifiers

NCT: NCT07098065 · GHW Trial for smokers

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗