<?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>IRCT20180923041100N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-24</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Promoting Nutritional Behaviors in Students</public_title>
      <acronym></acronym>
      <scientific_title>Design and Evaluation of the Promotion Healthy and Safe Nutrition Behaviors Program in High School Female Students Using Health Action Model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34036</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Multi-stage random cluster sampling is performed. In the first stage, from four districts of educational, two districts are selected randomly Simple. In the next stage, randomly simple, two Governmental girls' high schools are selected from each district. A school is considered as an intervention group and another school is considered as the control group and is selected from two districts of four schools. In the final stage, two classes of the 8th grade from each school are selected randomly Simple. A total of 4 classes of the 8th grade are placed in the intervention group and 4th classes of the 8th grade are placed in the control group. A random numbers table is used to select randomly Simple.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Design and Evaluation of Promoting Healthy and Safe Nutrition Behaviors Program in High School Girls Students Using Health Action Model.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention is an educational type that is implemented in intervention group students to promote healthy and safe nutrition behaviors. An educational program based on educational content designed using interactive methods in educational sessions will be implemented. In addition, the pamphlet contains key points related to the final conclusion of the topics discussed in each training session is provided and will be given to the students. Intervention 2: Control group: High school girl students in Shiraz schools who do not receive any interventions.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of the data and documentation listed in above can be shared.

When:
Start the access to documentation, 3 months after the publication of the article

To whom:
Researchers that working in academic and scientific institutions

Conditions:
The provision of documentation and data files is with condition that there is no interference in the data and documentation of the study without the consent of the researcher.

Where to obtain:
Dr. Mohammad Ali  Morowatisharifabad, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran,  Email:morowatisharif@yahoo.com
Leila Moradi, School of Health, Shiraz University of Medical Sciences, Iran,  Email: lmoradi20072007@yahoo.com

How to obtain:
Send the email to the persons listed above and to review request the applicant and to provide information within a maximum of one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 16, Alley 5, Qasr- Dasht Avenue, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098717133873757</zip>
        <telephone>+98 71 3233 7799</telephone>
        <email>lmoradi20072007@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Ali Morowatisharifabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>035-38209119</zip>
        <telephone>+98 353820910014</telephone>
        <email>morowatisharif@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Eighth grade girl's students
They are studying in governmental high schools in Shiraz.
Students tend to participate in the study.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to cooperate
Not attending in the training sessions more than 2 sessions
Not attending in the post-test
Exit from the study due to a transfer of students from the school, leave the school or immigration from Shiraz.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention is an educational type that is implemented in intervention group students to promote healthy and safe nutrition behaviors. An educational program based on educational content designed using interactive methods in educational sessions will be implemented. In addition, the pamphlet contains key points related to the final conclusion of the topics discussed in each training session is provided and will be given to the students.</i_keyword>
      <i_keyword>Control group: High school girl students in Shiraz schools who do not receive any interventions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determine and compare the mean score of healthy and safe nutrition behavior of girl's students in two groups of intervention and control before and after intervention. Timepoint: At the beginning of the study (before the intervention) and 2 months after the end of the intervention. Method of measurement: Researcher-made Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-24</approval_date>
        <contact_name>National Ethics Committee in Biomedical Research</contact_name>
        <contact_address>School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
