Ignite Creation Date:
2024-05-11 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399588
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-26
Brief Title:
Intervention for Adolescent Tobacco Initiation Prevention
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Intervention for Adolescent Tobacco Initiation Prevention IATIP to Promote Health and Well-being A Protocol for a Pilot Feasibility Cluster Randomised Controlled Trial in Dhaka Bangladesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IATIP
Brief 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
Detailed 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 N1280 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 trials success may pave the way for future large-scale definitive trials influencing national policies and strategies
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 N1280 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 trials success may pave the way for future large-scale definitive trials influencing national policies and strategies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None