Evaluation of the Effectiveness of 5A-5R Counselling Services for Tobacco Cessation
NCT Number: NCT06501209
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Use Cessation
Interventions: BEHAVIORAL: 5A-5R-based counselling session|BEHAVIORAL: Counseling through mobile phone call and text message
Sponsor: BRAC University
Collaborators: Bangladesh Center for Communication Programs|Non Communicable Disease Control Program, DGHS, Bangladesh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 714
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-05-10
Completion Date: 2024-11-30
Locations: BRAC James P Grant School of Public Health, Dhaka, 1213, Bangladesh

Summary:
Noncommunicable diseases (NCDs) are a major health burden in Bangladesh, following global trends. Tobacco use, both smoking and smokeless, is a key risk factor for noncommunicable diseases (NCDs) such as cardiovascular disease, chronic lung disease, and cancer, accounting for a considerable portion of the country's mortality rate. The government has taken several steps to address this issue, including increasing tobacco pricing and implementing smoke-free rules. Despite efforts to lower tobacco demand, meeting the desired reduction in consumption appears difficult. Counseling emerges as a popular technique of smoke cessation, with research demonstrating its effectiveness. The 5A-5R counseling technique is a brief intervention that is encouraged by the Directorate General of Health Services (DGHS) in Bangladesh. This study aims to evaluate the effectiveness of mobile phone-assisted culturally appropriate 5A-5R counselling services for tobacco cessation among adults in union-level primary health care settings in Bangladesh. The trial will involve a cluster randomized controlled design with three arms: an intervention arm receiving in-person counselling, an intervention arm receiving in-person and mobile phone-assisted counselling, and a control arm receiving usual care without structured counselling. The primary outcome measures include tobacco cessation rates and reduction in tobacco consumption. The study duration is 8 months, with a preparatory phase, intervention phase, follow-up phase, and data analysis phase.

Primary Outcome Measures: Tobacco Cessation, The number of participants with a history of current tobacco use have quitted their tobacco intake in any form measured by descriptive statistics (n,%) using questionnaires., 8 months
Secondary Outcome Measures: Smoking Tobacco Reduction, Mean number of cigarette sticks consumed per day measured by descriptive statistics (mean, standard deviation) using questionnaires., 8 months|Smokeless Tobacco Reduction, Mean changes in the number of times (frequency) of smokeless tobacco consumption per day measured by descriptive statistics (mean, standard deviation) using questionnaires., 8 months|Change in knowledge, attitude, and practice of tobacco use by using 5 point Likert Scale., Proportion of change in knowledge by using a semi-structured questionnaire and increase in awareness of tobacco use by using 5 point Likert Scale., 8 months