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Development and Effectiveness of cognitive, behavioral and social interventions on smoke use prevention (CIPS) among adolescents (15-19 Years Old) pirbakran city: a community-based Mixed method Study

Protocol summary

Study aim
Determination and comparison of mean scores of cognitive variables one and six months after the intervention - Determining and comparing the mean scores of social variables one and six months after the intervention - Determination and comparison of smoking behavior in adolescents one month and six months after the intervention
Design
Samples were categorized into two sexes and each category 2 high school and secondary school will consider as a cluster. The proportion of each school will determine by the sample size(73 persons). Since the samples studied one and six months after the intervention are not necessarily the same as those before the intervention (73 persons), the researcher and the other team members have no information about the sample.
Settings and conduct
The intervention is a community-based without a control group that will take about two months. Educational intervention in the form of a city-wide exhibition on the outcomes of smoking, sending educational messages, designing educational reference sites, holding paintings on the outcomes of smoking in schools, educational sessions, etc. for some adolescents and their parents.
Participants/Inclusion and exclusion criteria
Residing in Pirbakran, Adolescents age 15-19 years
Intervention groups
The intervention is a community-based without a control group that will take about two months. Educational intervention in the form of a city-wide exhibition on the outcomes of smoking, sending educational messages through social networks, establishing banners in the environment, designing educational reference sites, holding paintings on the outcomes of smoking in schools, educational sessions, etc.
Main outcome variables
using smoking, Outcome expectancy, Self-regulation, Self-efficacy, Self-esteem, Family and School Function

General information

Reason for update
Acronym
CIPS
IRCT registration information
IRCT registration number: IRCT20200101045980N1
Registration date: 2020-02-04, 1398/11/15
Registration timing: registered_while_recruiting

Last update: 2020-02-04, 1398/11/15
Update count: 0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
hajar rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3744 2638
Email address
h.rezaee@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-27, 1398/04/06
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and Effectiveness of cognitive, behavioral and social interventions on smoke use prevention (CIPS) among adolescents (15-19 Years Old) pirbakran city: a community-based Mixed method Study
Public title
Development and Effectiveness of cognitive, behavioral and social interventions on smoke use prevention (CIPS) among adolescents (15-19 Years Old): a community-based Mixed method Study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Residing in Pirbakran city adolescents 15-19 Years Old
Exclusion criteria:
Questionnaires are incomplete
Age
From 15 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 73
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is a community-based study without a control group. All participants receive educational intervention directly and indirectly.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City
City
Isfahan
Province
Isfehan
Postal code
8178963539
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.116

Health conditions studied

1

Description of health condition studied
smoking
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cigarette smoking behavior
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire

2

Description
Outcome expectancy in a research-made questionnaire from a Mixed Study
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire from a Mixed Study

3

Description
Outcome expectation in a research-made questionnaire from a Mixed Study
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire from a Mixed Study

4

Description
Self-regulation in a research-made questionnaire from a Mixed Study
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire from a Mixed Study

5

Description
Self-efficacy in a research-made questionnaire from a Mixed Study
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire from a Mixed Study

6

Description
Self-esteem in a research-made questionnaire from a Mixed Study
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire from a Mixed Study

7

Description
Family Function in a research-made questionnaire from a Mixed Study
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire from a Mixed Study

8

Description
School Function in a research-made questionnaire from a Mixed Study
Timepoint
Before intervention, one and six months after intervention
Method of measurement
research-made questionnaire from a Mixed Study

Secondary outcomes

empty

Intervention groups

1

Description
Educational intervention in the form of a city-wide exhibition on the outcomes of smoking, sending educational messages through social networks, drawing competitions on the consequences of smoking and secondhand smoke in schools, designing educational reference websites, holding educational sessions. It will do for some adolescent and parents.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Pir Bakran City Schools
Full name of responsible person
Hajar Rezaei
Street address
First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City
City
Isfahan
Province
Isfehan
Postal code
8178963539
Phone
+98 31 3744 2638
Email
h.rezaee@hlth.mui.ac.ir
Web page address
http://nocigarette.blogfa.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences., Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Rezaei
Position
PhD Candidate, Health Education and Health Promotion, Department of Health Education and Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City
City
Isfahan
Province
Isfehan
Postal code
8178963539
Phone
+98 31 3744 2638
Email
h.rezaee@hlth.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Rezaei
Position
PhD Candidate, Health Education and Health Promotion, Department of Health Education and Promotion,F
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City
City
Isfahan
Province
Isfehan
Postal code
8178963539
Phone
+98 31 3744 2638
Email
h.rezaee@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Rezaei
Position
PhD Candidate, Health Education and Health Promotion, Department of Health Education and Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City
City
Isfahan
Province
Isfehan
Postal code
8178963539
Phone
+98 31 3744 2638
Email
h.rezaee@hlth.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' data file, consent form, codes used in the analysis, data classification system, and statistical analysis plan will provide to the responsible persons if necessary for accuracy of the information and... The study protocol will publish as a rational model of education to prevent smoking in adolescents The results of this study and the clinical trial report will publish in the form of an article.
When the data will become available and for how long
From the second half of the year 1399
To whom data/document is available
Research committees and responsible for the journal to verify the results of the study
Under which criteria data/document could be used
- Considering the development of the questionnaire the use of this questionnaire in future studies - the use of interventions to prevent smoking in adolescents
From where data/document is obtainable
E-mail the Research Committees and the journal responsible for the validity of the study results
What processes are involved for a request to access data/document
Valid e-mail-related research organizations
Comments
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