Determining the effect of educational intervention program to preventive cigarette smoking on female high school students
Design
Based on the results of the qualitative part of the study, the study was designed and performed on 300 adolescent girls in two control groups (n=150) and intervention (n=150) without randomization and blindness. Data collection will be performed using a researcher-made questionnaire (valid and reliable) based on the results of the qualitative section. The data will be analyzed using SPSS statistical software version 22 using descriptive and inferential methods. Significant levels in all tests will be determined to be less than 0.05. The statistical population studied will be selected by a multi-stage sampling method. First, a list of all high school girls will be prepared, and then the samples will be randomly divided into two groups of intervention and control.
Settings and conduct
This study will be performed on female high school students in Mashhad.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The student is in the second grade of high school, resident of Mashhad, and willing to participate in the study.
Exclusion criteria:
Having one or more session absentee at training sessions, students who participated in the pre-test but were not present in the post-test, and changing their schools.
Intervention groups
In this intervention study, a training program on cigarette smoking was conducted for 4 sessions of 2 hours for students in the experimental group for a maximum of one month.
Main outcome variables
Determine the average score of students' preventive behaviors in relation to cigarette smoking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180722040559N5
Registration date:2020-06-19, 1399/03/30
Registration timing:prospective
Last update:2020-06-19, 1399/03/30
Update count:0
Registration date
2020-06-19, 1399/03/30
Registrant information
Name
Alireza Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3851 4548
Email address
jafaria962@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-05-08, 1400/02/18
Actual recruitment start date
2020-08-09, 1399/05/19
Actual recruitment end date
2020-10-11, 1399/07/20
Trial completion date
2021-05-10, 1400/02/20
Scientific title
Explaining the process of smoking in girls’ adolescents, Implementing and evaluating this process to prevent cigarette smoking
Public title
The effect of educational intervention program to preventive cigarette smoking on female high school students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The student is in the second grade of high school
Resident of Mashhad
Willing to participate in the study
Exclusion criteria:
Having one or more session absentee at training sessions
Students who participated in the pre-test but were not present in the post-test
Changing their schools
Age
From 15 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Actual sample size reached:
300
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical sciences
Street address
School of Health, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.MUMS.REC.1398.153
Health conditions studied
1
Description of health condition studied
The preventive of cigarette smoking
ICD-10 code
305.1
ICD-10 code description
Tobacco use disorder
Primary outcomes
1
Description
The preventive cigarette smoking
Timepoint
One month after the meeting and after the test made by questionnaire, the two groups will be measured
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, training program was performed with 4 sessions of 120 minutes
Category
Prevention
2
Description
Control group: No intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Female high school
Full name of responsible person
Alireza Jafari
Street address
School of Health, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3851 4548
Email
jafari.ar94@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Street address
School of Health, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3851 4548
Email
jafari.ar94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
School of Health, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3851 4548
Email
jafari.ar94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
School of Health, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
051- 38514548
Email
jafari.ar94@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
School of Health, Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3851 4548
Email
jafari.ar94@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Potential data is shareable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Start the access period one month after the publication of result
Under which criteria data/document could be used
Researchers working in academia
From where data/document is obtainable
Data is sent through an official request and by email
What processes are involved for a request to access data/document