Clinical Trials Logo

Clinical Trial Summary

This school-based cluster randomized controlled trial aims to assess the feasibility of implementing the Adolescent Tobacco Initiation Prevention (IATIP) and evaluate the potential efficacy of IATIP in preventing tobacco initiation and promoting the health and well-being of school adolescents in Dhaka, Bangladesh. The intervention consists of three 40-minute sessions, delivered over three successive days, including knowledge and skill-based lectures, interactive activities, and materials targeting tobacco prevention and health promotion.


Clinical Trial Description

Background and Aims: Adolescent tobacco use is a significant public health challenge, particularly in low- and middle-income countries like Bangladesh. An Intervention for Adolescent Tobacco Initiation Prevention (IATIP) has been developed to address this issue. This study aims to assess the feasibility of implementing the IATIP and evaluate its potential efficacy in preventing tobacco initiation and promoting health and well-being. Design: Pilot feasibility school-based cluster randomized controlled trial. Setting: Secondary schools in Dhaka city, Bangladesh. Participants: Adolescents in school years 8 and 9 attending participating schools in Dhaka (K = 8 clusters; N~1280 participants). Intervention: The intervention consists of three 40-minute sessions, delivered over three successive days, including knowledge and skill-based lectures, interactive activities, and materials targeting tobacco prevention and health promotion. This intervention was developed based on evidence gathered from a quantitative survey, qualitative focus groups, and a systematic review. Measurements: The primary outcome is the feasibility of the intervention, assessed with recruitment and attrition rates, fidelity of delivery and acceptability. Secondary outcomes include the change in intention to initiate tobacco use; tobacco knowledge, attitudes, and beliefs; skills development related to tobacco resistance; and the promotion of mental well-being. Data will be collected through structured questionnaires administered at baseline and 1-month follow-up assessments for both intervention and control groups. A post-intervention process evaluation will be conducted among the students who participated in the intervention and the teachers using a mixed-method approach, incorporating both questionnaires and semi-structured interviews, to gain insights into intervention implementation, facilitation, participant experiences, and identify potential areas for improvement. Comments: This pilot feasibility trial addresses a critical gap in tobacco prevention initiatives tailored for Bangladeshi school adolescents. By combining evidence-based strategies, IATIP aims to empower adolescents with the knowledge and skills needed to resist tobacco initiation, while also targeting specific components to improve health and well-being, recognising the interconnected challenges of tobacco use and health and well-being among adolescents. Successful implementation of this pilot trial has the potential to reduce the intention to initiate tobacco use, limit exposure to second-hand smoke, and contribute to the overall health and well-being of school adolescents. Given the scalability of school-based interventions, the trial's success may pave the way for future large-scale definitive trials, influencing national policies and strategies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06399588
Study type Interventional
Source University College, London
Contact Sahadat Hossain, MSPH
Phone +447448006075
Email sahadat.hossain.21@ucl.ac.uk
Status Not yet recruiting
Phase N/A
Start date May 2, 2024
Completion date December 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04152824 - Readiness Supportive Leadership Training N/A
Completed NCT03555435 - Pilot Study of Peer-Supported Online Problem-Solving Program N/A
Completed NCT03274934 - The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control N/A
Not yet recruiting NCT05888415 - WELL-being Improvement Following Sophrology Practice
Completed NCT02191553 - Differential Effect of Four Mindfulness Exercises N/A
Completed NCT02906306 - Effects of Individual and Group Occupational Therapy on General Self-Efficacy, Psychological Well-Being, Personal Independence and Occupational Therapy in Older Adults N/A
Completed NCT01376986 - Activation of Young Men - Population-Based Randomised Controlled Trial N/A
Recruiting NCT03356691 - The Evaluation Complementary Spirit Therapy N/A
Completed NCT04955457 - BDNF Promoter Methylation: Effects on Cognition, Stress and Anxiety and Depression Symptom in Healthy Women.
Completed NCT02544412 - A Well-being Training for Preservice Teachers N/A
Completed NCT05486156 - Evaluation of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature N/A
Completed NCT03306654 - Efficacy of Three Online Well-Being Programs to Improve Work-Related Outcomes N/A
Recruiting NCT02898285 - Promoting Sport Participation During Early Parenthood N/A
Completed NCT04719858 - Effect of #LIFEGOALS on Adolescents' Mental Health N/A
Completed NCT05397249 - The Impact of Mindfulness and Spirituality on Student Well-being N/A
Completed NCT04139005 - Well-being and the HM App Pilot (WHAP) Study N/A
Enrolling by invitation NCT04602832 - Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 N/A
Active, not recruiting NCT05931432 - A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID N/A
Enrolling by invitation NCT05068765 - The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers N/A
Completed NCT05608304 - Formal Versus Informal Mindfulness Among University Students With and Without Recent Nonsuicidal Self-injury N/A