<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200811048361N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of peer education on knowledge, attitude and preventive behaviors related to type 2 diabetes amgon Adolescents of Tehran City"</public_title>
      <acronym></acronym>
      <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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50221</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ameneh pooresmaeildorosteh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, Shahid Sebghati Alley, Salman Farsi Ave., Islamshahr</address>
        <city>Islamshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33139-37897</zip>
        <telephone>+98 21 5614 6580</telephone>
        <email>am.pooresmaeili@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Rakhshanderou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health and Saftey, Shahid Beheshti University of Medical Sciences, Tabnak Ave., Daneshjou Blvd., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19835-35511</zip>
        <telephone>+98 212243 2036-7</telephone>
        <email>S_rakhshanderou@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People with type 1 diabetes and type 2 diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Preventive behaviors. Timepoint: At the beginning of the study (before the intervention) and 2 months after the intervention. Method of measurement: questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-04</approval_date>
        <contact_name>Ethics Committee  of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>No. 12, Shahid Sebghati Alley, Salman Farsi Ave., Islamshahr Islamshahr Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
