Protocol summary

Study aim
Determining the effect of peer education on knowledge, attitude and preventive behaviors related to type 2 diabetes amgon Adolescents of Tehran City
Design
This study has an intervention and control group that are randomly selected. Randomization is based on the list of schools and the list of students of selected schools.
Settings and conduct
After the necessary coordination, first the city of Tehran is divided into 5 parts according to the geographical map (northeast, southeast, center, northwest and southwest) and a municipal region is selected from each part, then refer to the education of the region. The list of high schools of the first period is prepared and according to the list of schools, a girls 'school and a boys' school are randomly selected (10 schools in total) and in each school from each grade based on the sample size and the share allocated to that school, knowledge Students will enter the study randomly based on the inclusion criteria. The questionnaires that were designed and psychometric in the first stage will be used in this stage to collect information and perform the intervention. . Based on the educational needs assessment of the target group, educational content is provided for them (definition of type 2 diabetes, causes and modifiable causes of type 2 diabetes, symptoms and complications, and ways to prevent type 2 diabetes). In this study, the peer method will be used for the intervention.
Participants/Inclusion and exclusion criteria
Inclusion requirements: Students studying in the first year of high school, students' willingness to participate in the study, Exclusion requirements: People with type 1 and 2 diabetes
Intervention groups
In this study, we have two groups: intervention group and control group. The intervention group receivededucation in type 2 diabetes
Main outcome variables
Preventive behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200811048361N1
Registration date: 2020-12-30, 1399/10/10
Registration timing: retrospective

Last update: 2020-12-30, 1399/10/10
Update count: 0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Ameneh Pooresmaeildorosteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5614 6580
Email address
am.pooresmaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and Psychometrics of a tool for measurement of Knowledge, Attitude and Preventive Behaviors of Type 2 Diabetes amgon Adolescents and its Application in an Interventional Study Using Peer Education
Public title
"The effect of peer education on knowledge, attitude and preventive behaviors related to type 2 diabetes amgon Adolescents of Tehran City"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
High school students studying in the first period The willingness of students to participate in study Lack of diabetes, type one and two
Exclusion criteria:
People with type 1 diabetes and type 2 diabetes
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in the first stage of the study (psychometrics) is multi-stage sampling. First, the city of Tehran is divided into 5 parts (northeast, southeast, center, northwest and southwest) according to the geographical map, and a municipal district is selected from each part, then a list of high schools for the first period is prepared. According to the list of schools, a school for girls and a school for boys are randomly selected (a total of 10 schools) and in each school from each grade based on the sample size and the share allocated to that school, students according to the inclusion criteria, will enter the study randomly. Sampling of the second part of the study (intervention): From the selected areas for sampling the psychometric section of an area was randomly selected and 4 schools were selected from girls' schools and these 4 schools were randomly assigned to the intervention and control group. Will be given (2 schools in the intervention group and 2 schools in the control group). The choice of schools will be such that the intervention group is geographically far enough from the control group so as not to interfere with education.
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 of Shahid Beheshti University of Medical Sciences
Street address
No. 12, Shahid Sebghati Alley, Salman Farsi Ave., Islamshahr
City
Islamshahr
Province
Tehran
Postal code
33139-37897
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.SBMU.PHNS.REC.1398.146

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Awareness scores obtained after the test
Timepoint
At the beginning of the study (before the intervention) and 2 months after the intervention
Method of measurement
questionnaire

2

Description
Attitude scores obtained after the test
Timepoint
At the beginning of the study (before the intervention) and 2 months after the intervention
Method of measurement
questionnaire

3

Description
Behavior scores obtained after the test
Timepoint
At the beginning of the study (before the intervention) and 2 months after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Preventive behaviors
Timepoint
At the beginning of the study (before the intervention) and 2 months after the intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: In this study, the educational intervention process will begin in a peer-to-peer manner by selecting a group of teaching peers. 12 students will be selected as peer educators. Selected peers, in 8 sessions of 1.5 hours with educational content including the areas mentioned in the questionnaire (definition of type 2 diabetes, causes and modifiable causes of type 2 diabetes, complications and ways to prevent type 2 diabetes) Will find. The trainings will be done to the peer group through lectures and questions and answers, using educational aids such as whiteboards and booklets. Then the training to the intervention group is started by the teaching peers for 2 months in eight sessions and each session lasts for 30 minutes. The method of providing trainings to the intervention group by peers is mainly through lectures, questions and answers, group discussions, installation of educational tracts containing health messages in public places of the school and inserting health messages on the blackboard of the classroom before the teachers arrive.
Category
Prevention

2

Description
Control group: While studying, the control group does not receive educational intervention. At the end of the work, educational intervention will be presented to the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected schools in Tehran
Full name of responsible person
Ameneh pooresmaeildorosteh
Street address
No. 12, Shahid Sebghati Alley, Salman Farsi Ave., Islamshahr
City
Islamshahr
Province
Tehran
Postal code
33139-37897
Phone
+98 21 5614 6580
Email
am.pooresmaeili@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarqi
Street address
No. 2660, Valiasr Ave., Shahid Beheshti School of Pharmacy, Tehran
City
Tehran
Province
Tehran
Postal code
6153- 14155
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
Web page address
https://fa.irct.ir/user/trial/50221/update/sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ameneh pooresmaeildorosteh
Position
PhD student in health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No. 12, Shahid Sebghati Alley, Salman Farsi Ave., Islamshahr
City
Islamshahr
Province
Tehran
Postal code
33139-37897
Phone
+98 21 5614 6580
Email
am.pooresmaeili@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sakineh Rakhshanderou
Position
Assistant Professor of Health Education & Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health and Saftey, Shahid Beheshti University of Medical Sciences, Tabnak Ave., Daneshjou Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
19835-35511
Phone
+98 212243 2036-7
Email
S_rakhshanderou@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ameneh pooresmaeildorosteh
Position
PhD student in health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No. 12, Shahid Sebghati Alley, Salman Farsi Ave., Islamshahr
City
Islamshahr
Province
Tehran
Postal code
33139-37897
Phone
0098 2146580
Email
am.pooresmaeili@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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