<?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>IRCT20200224046600N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-03</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Health Belief Model Training on High Risk Behaviors of Female Students</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Education based on Health Belief Model on High Risk Health Behaviors among Female Students of the Mashhad University of Medical Sciences.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46162</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: From among the Dormitories for Girls in Mashhad University of Medical Sciences, two Dormitories will be Randomly Selected by lottery. Thus, the Control Group will be Selected from one Dormitory and the Intervention Group will be Selected from another.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of Education based on Health Belief Model on High Risk Health Behaviors among Students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Intervention will be Conducted weekly in Six 60- to 90 Minute Sessions. The Method of Delivering the Training will be based on the Content of each Session, with lectures using Power Point and film Screening (with the approval of the Ethics Committee representative), Question and Answer, Group Discussion, and role Playing. Intervention 2: Control group: Education is Received on a Regular basis (Meaning Educational Materials or Tutorials that Students use Available Resources that Include both Groups). But after the Study, if the Study is Successful, the Control Group will also be offered Training.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasrin Zahmatkesh Rokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery, Ebne Sina Avenue، Doktora Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91889-93684</zip>
        <telephone>+98 51 3893 4278</telephone>
        <email>zahmatkeshrz971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Ebrahimzadeh Zgemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery, Ebne Sina Avenue، Doktora Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>EbrahimzadehZS@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed Consent to Participate in the Research
Their gender is Female
Having a Phone Number to Call
Student of Undergraduate or Postgraduate or PHD in one of the Faculties of Medical Sciences in Mashhad
Residence in Dormitories Covered by Mashhad University of Medical Sciences
Students must be between 18 and 30 Years of age.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Questionnaires are not Completed Properly
Not Participating in more than One Training Session
Vacation or Quit Studying for any Reason
Accidents (Death of a Loved one, Earthquake, Accidents and Illness).</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Intervention will be Conducted weekly in Six 60- to 90 Minute Sessions. The Method of Delivering the Training will be based on the Content of each Session, with lectures using Power Point and film Screening (with the approval of the Ethics Committee representative), Question and Answer, Group Discussion, and role Playing.</i_keyword>
      <i_keyword>Control group: Education is Received on a Regular basis (Meaning Educational Materials or Tutorials that Students use Available Resources that Include both Groups). But after the Study, if the Study is Successful, the Control Group will also be offered Training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tobacco Smoking Behavior Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Youth Health Risk Behaviors Questionnaire (2019).</prim_outcome>
      <prim_outcome>Addiction Behavior and Substance Abuse Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Youth Health Risk Behaviors Questionnaire (2019).</prim_outcome>
      <prim_outcome>Unhealthy Sexual Behaviors Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Youth Health Risk Behaviors Questionnaire (2019).</prim_outcome>
      <prim_outcome>Physical Inactivity Behavior Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Youth Health Risk Behaviors Questionnaire (2019).</prim_outcome>
      <prim_outcome>Unhealthy Eating Behavior Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Youth Health Risk Behaviors Questionnaire (2019).</prim_outcome>
      <prim_outcome>Scores of Behaviors related to Injuries. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Youth Health Risk Behaviors Questionnaire (2019).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perceived Sensitivity Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Researcher-made Questionnaire based on Health Belief Model Constructs.</sec_outcome>
      <sec_outcome>Perceived Severity Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Researcher-made Questionnaire based on Health Belief Model Constructs.</sec_outcome>
      <sec_outcome>Perceived Benefit score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Researcher-made Questionnaire based on Health Belief Model Constructs.</sec_outcome>
      <sec_outcome>Perceived Barriers Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Researcher-made Questionnaire based on Health Belief Model Constructs.</sec_outcome>
      <sec_outcome>Practice Guide Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Researcher-made Questionnaire based on Health Belief Model Constructs.</sec_outcome>
      <sec_outcome>Self-Efficacy Score. Timepoint: Before Intervention, Immediately and One Month after Intervention. Method of measurement: Researcher-made Questionnaire based on Health Belief Model Constructs.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-21</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Central Organization of Mashhad University of Medical Sciences ، Daneshgah Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
