Main objective of the project:
Determining the Effect of Teaching Peers on Prevention of Highly Risked Behaviors in Adolescent Girls
Design
Two arm parallel group randomized clinical trial. Total sample size: 120
Random assignment to intervention and control groups, not blind, not apply
Settings and conduct
One of the second high school students in the 17th district of Tehran
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Teenage girls aged 15 to 18 years old؛Having the consent to participate in the study؛Lack of physical problems or problems of understanding and learning with the views of schools and self-expression؛ Choosing peer educators based on people's desire, competence and acceptability with the view of managers.
Exit criteria: Absence of two consecutive sessions of training sessions؛ Transfer from school
Intervention groups
Samples in each intervention and control group 60.They are randomly assigned to 6-member friendly groups and will be divided into two groups of test and control. In this study, high-risk behaviors of adolescents in three domains: unintentional and intentional injuries , Nutritional behaviors and physical activity. In order to carry out the intervention for each cluster, 1 student will be selected as a coach of 10 peers. The training program will then be provided to 4 peers for 90 minutes twice a week for peer educators. After conducting the classes, Each of the coaches in the 6-person group teaches prevention of high-risk behaviors. After 6 weeks, educational intervention will be measured.Finally, in the form of a session and a booklet on prevention of high-risk behaviors for the control group, they will be presented
Main outcome variables
Determination and comparison of nutritional behaviors; Physical activity; Intentional and unintentional injuries
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180716040499N1
Registration date:2019-02-10, 1397/11/21
Registration timing:retrospective
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Elham Noei Aghabagher
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2631 1520
Email address
e-noeia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-27, 1397/07/05
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
2018-09-27, 1397/07/05
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
The effect of peer education on prevention of high risk behaviors among in adolescent girls
Public title
effect of peer education on prevention of high risk behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Selection of peer educators based on people's desire, competence and acceptability with the view of managers.
Having the consent to participate in the study
Teenage girls aged 15 to 18 years old
Choosing peer educators based on people's desire, competence and acceptability with the view of managers.
Exclusion criteria:
Having physical problems or problems of understanding and learning With Self-declaration and opinion of school principal
Age
From 15 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-step random sampling method will be used. To do this, out of 12 high schoolsof girls covered by area 17, randomly one school will be selected. The research samples were assigned to 60 subjects in each experimental and control group. For random assignment of the samples randomly, the students were coded according to the volume of the desired 6-member friendly groups and divided into two groups Test and control.
From 12 schools
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
Ethics committee School of Nursing Midwifery ,Tehran University of Medical Sciences
Street address
East Nusrat, Dr Mirkhani Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.TUMS.FNM.REC.1397.006
Health conditions studied
1
Description of health condition studied
The effect of peer education on prevention of high risk behaviors among in adolescent girls
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pevention of high risk behavior
Timepoint
befor and 6 weeks after the intervention
Method of measurement
High-risk behaviors questionnaire for 18-18 year-old adolescents
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:peer education in intervention group
Category
Prevention
2
Description
Control group: no intervention in control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Moallem Shahid Dokhanchi High school
Full name of responsible person
Elham Noei Aghabagher
Street address
No. 24539, Shahid Solati Alley, Shahid ELmi Street, Abouzar Blvd
City
Tehran
Province
Tehran
Postal code
6611223344
Phone
+98 21 5570 8711
Email
se@medu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahzad Pashaei
Street address
East Nusrat,Dr Mirkhani Street,Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
fnm@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Elham Noei Aghabagher
Position
Student Master of Community health nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East Nusrat, Dr Mirkhani St, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
elham_na27@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Noei Aghabagher
Position
Student Master of Community health nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East Nusrat, Dr Mirkhani St, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
elham_na27@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Noei Aghabagher
Position
Student Master of Science in Community health nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East Nusrat, Dr Mirkhani St, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
e-noeia@razi.tums.ac.ir
Web page address
http://fnm.tums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
After the article is published, it is possible to access data
To whom data/document is available
All interested
Under which criteria data/document could be used
To conduct research
From where data/document is obtainable
Email Researcher
What processes are involved for a request to access data/document