Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels and Smoking Behavior Among Early Adolescents in Jordan

Asthma Clinical Trial

— TAJPlus  

Official title:

Efficacy of School-Based, Peer-Led Asthma and Smoking Prevention Program on CO1 Levels, Nicotine Dependence, and Smoking Behavior Among Early Adolescents in Jordan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938976
• Other study ID #: 96/2012
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2013
• Last updated: September 5, 2013
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: University of Technology, Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Study Hypotheses:

1. adolescents in intervention schools who are given Triple A program plus ASP will show more awareness in regards to cigarettee smoking health effects and less nicotine dependencethan those in the control schools who are given Triple A alone.

2. adolescents with asthma in intervention schools who are given Triple A program plus ASP will show less asthma symptoms and better control than those in the control schools who are given Triple A alone.

3. adolescent smokers and passive smokers will exhibit higher levels of carbon monoxide (CO) in their breath than those who are not active or passive smokers.

4. there is a positive correlation between self-report questions regarding student smoking status and levels of CO in their breath

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria: students in grades 7 and 8 in Irbid city high schools, can speak and read in both Arabic and English, obtain parental agreement, attend regular school.

Exclusion Criteria:students with other chronic diseases (rather than asthma),

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Cigarettes
• Tobacco
• Waterpipe

Intervention

Behavioral:
• TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge
Its is a school-based peer-led asthma and smoking prevention program that aims at improving asthma control and lowering nicotine dependence among smokers.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Technology, Sydney	Jordan University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nicotine dependence level	Self-administered nicotine dependence scale will be used in order to measure nicotine dependence level for adolescent smokers and passive smokers	3 months	No
Primary	Asthma Contol level	The pictorial version of the asthma control test will be measured for adolescents with asthma and recent wheezing	3 months	No
Secondary	Carbon monoxide (CO) breath test	CO levels will be tested in adolescents' breath	3 months	No
Secondary	knowledge about health effects of cigarettee smoking		3 months	No