<?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>IRCT20130311012792N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-21</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Education Based on Health Belief Model on Promoting Preventive Behaviors of Mothers from Girls' Early Puberty</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effectiveness of Education and Lack of Education Based on Health Belief Model on Promoting the Preventive Behaviors of Mothers from  Girls' Early Puberty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28963</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preventive Behaviors of Early Puberty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Implementing educational sessions (Two one-hour sessions), based on health belief model with lecture, question and answer method, and educational pamphlet for the mothers of the test group. Intervention 2: Control group: No educational sessions (no intervention).</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>Mina Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Sciences, Sheykh Bahahei Ave., Molla Sadra Ave., Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1698749511</zip>
        <telephone>+98 21 7634 4759</telephone>
        <email>minajalali765@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheykh Bahaei Ave., Molla Sadra Ave., Baqiyatallah University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1698749511</zip>
        <telephone>+98 76344759</telephone>
        <email>mahrooz.javadi@hotmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers (the samples) who having literacy to read and write
participating in educational sessions and tests in before and after education
Mothers who having five to seven years old girl
Mothers not having a history of early puberty
Mothers not having a child with early puberty</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>43 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cancel continue participating in educational sessions</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Implementing educational sessions (Two one-hour sessions), based on health belief model with lecture, question and answer method, and educational pamphlet for the mothers of the test group</i_keyword>
      <i_keyword>Control group: No educational sessions (no intervention)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive Behaviors of Early Puberty. Timepoint: Before and one Month after the Educational Intervention. Method of measurement: Researcher-made questionnaire based on Health Belief Model.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Perceived susceptibility. Timepoint: Before and one Month after the Educational Intervention. Method of measurement: Researcher-made questionnaire based on Health Belief Model.</sec_outcome>
      <sec_outcome>Perceived severity. Timepoint: Before and one Month after the Educational Intervention. Method of measurement: Researcher-made questionnaire based on Health Belief Model.</sec_outcome>
      <sec_outcome>Perceived benefits. Timepoint: Before and one Month after the Educational Intervention. Method of measurement: Researcher-made questionnaire based on Health Belief Model.</sec_outcome>
      <sec_outcome>Perceived barriers. Timepoint: Before and one Month after the Educational Intervention. Method of measurement: Researcher-made questionnaire based on Health Belief Model.</sec_outcome>
      <sec_outcome>Self-efficacy. Timepoint: Before and one Month after the Educational Intervention. Method of measurement: Researcher-made questionnaire based on Health Belief Model.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-12</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah University of Medical Sciences, Sheykh Bahaei Ave., Molla Sadra Ave., Vanak Square. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
