Intervention for Adolescent Tobacco Initiation Prevention (IATIP)

University College London (UCL)

Status: Not yet enrolling

Conditions: Well-being; Tobacco Prevention; Health Behaviour

Treatments: Behavioral: Intervention for Adolescent Tobacco Initiation Prevention (IATIP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06399588

22645/004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,280 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Bangladeshi school adolescent
• Students at one of the participating schools
• Students of Years 8 and 9

Exclusion criteria

• Students of physical and mental impairment
• don't understand and read the 'Bangla' language
• don't have parental consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,280 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention for Adolescent Tobacco Initiation Prevention (IATIP)

Control group

No Intervention group

Description:

Participating schools in the control group will maintain their regular ongoing activities without introducing the IATIP. Students in the control group will not receive any specific anti-tobacco or health and well-being promotion materials beyond their standard school curriculum.