Health Warnings and Counseling at Primary Health Care Centers for Smoking Cessation and NCD Prevention: A Randomized Controlled Trial in Bangladesh and Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,400
- 试验地点
- 1
- 主要终点
- Self-reported 7-day point prevalence abstinence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Without pregnancy and lactation
- •Without cognitive or psychiatric conditions,
- •Without severe medical conditions,
- •Participation in other studies, and inability to consent.
研究组 & 干预措施
GHW-only intervention
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.
干预措施: Graphical health warnings (Behavioral)
GHW 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.
干预措施: Graphical health warnings plus pharmacist-led counselling (Behavioral)
Standard care control
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.
干预措施: Routine pharmacy services (no intervention) (Other)
结局指标
主要结局
Self-reported 7-day point prevalence abstinence
时间窗: 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
Verified smoking cessation rates
时间窗: Baseline, 6 months, and 12 months post-intervention.
Percentage of participants who report smoking cessation
Change in Systolic Blood Pressure (SBP)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Baseline, 6 months, and 12 months.
Percentage increase in correct responses to questions on the health effects of smoking.
次要结局
- Improved Hypertension Management(6 and 12 months.)
- Improved Diabetes Management(6 and 12 months.)
- Hospital Admissions(6 and 12 months.)
- Increase in Physical Activity(6 and 12 months.)
- Incremental Cost-Effectiveness Ratio(At 12 months.)
- Image-Based Biomarker Assessment (Exploratory Secondary Outcome)(Time Frame: Baseline and 12 months.)
- Reduction in Cigarette Consumption(6 and 12 months.)
- Quit Attempts(6 and 12 months.)
- Readiness to Quit Smoking(6 and 12 months.)
- Improvement in Knowledge About Smoking Harms(6 and 12 months.)
- Change in Quality-Adjusted Life Years (QALYs)(6 and 12 months.)
- Diet Quality(6 and 12 months.)
- Change in Cigarette Consumption(6 and 12 months.)
- Improved Hypertension Management(6 and 12 months.)
- Improved Diabetes Management(6 and 12 months.)
- Hospital Admissions(6 and 12 months.)
- All-Cause Mortality(Up to 12 months.)
- Increase in Physical Activity(6 and 12 months.)
- Incremental Cost-Effectiveness Ratio(At 12 months.)
- Image-Based Biomarker Assessment (Exploratory Secondary Outcome)(Time Frame: Baseline and 12 months.)
研究者
Md. Mizanur Rahman, PhD
Associate Professor
Hitotsubashi University