<?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>IRCT2014042315797N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-07-12</date_registration>
      <primary_sponsor>Vice chancellor for research, Hamadan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of health promotion interventions on nutritional behaviors</public_title>
      <acronym></acronym>
      <scientific_title>Effect of community-based health promotion interventions on nutritional behaviors of households in Hamadan city  by  applying the combined model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>842</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14955</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nutritional behaviors.</hc_freetext>
      <i_freetext>Intervention 1: Interventions will be performed using Train to trainer strategy to promote nutritional behaviors of mothers and students. In this method, teachers and school health educators will be trained, to teach the students about healthy eating behaviors. Finally, mothers will be trained by students. Interventions for 3 months included: education about food groups and nutritional behaviors; providing educational aids including pamphlet, booklet, display video and banner installation; holding painting competitions and providing wallpaper to promote nutritional behaviors. To assess the rate of learning, mothers and students will write their homework in the logbook. Intervention 2: For the control group will not perform any of the action that will be taken for the intervention 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Zeinab Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65155</zip>
        <telephone>+98 81 3838 1641</telephone>
        <email>hashemi_boshra@yahoo.com; z.hashemi@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mohammad Mahdi Hazavehei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3838 1641</telephone>
        <email>hazavehei@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Fifth grade student; mother or supervisor of the child who is charged with the responsibility of cooking in the family Exclusion criteria:  Transferring student to another school.; lack of willingness of students to continue participating in the study; lack of willingness of mother or child supervisor to continue participating in the study; having specific diet due to illness or other reasons</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inappropriate diet and eating habits</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions will be performed using Train to trainer strategy to promote nutritional behaviors of mothers and students. In this method, teachers and school health educators will be trained, to teach the students about healthy eating behaviors. Finally, mothers will be trained by students. Interventions for 3 months included: education about food groups and nutritional behaviors; providing educational aids including pamphlet, booklet, display video and banner installation; holding painting competitions and providing wallpaper to promote nutritional behaviors. To assess the rate of learning, mothers and students will write their homework in the logbook.</i_keyword>
      <i_keyword>For the control group will not perform any of the action that will be taken for the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Constructs of combined health education and promotion model. Timepoint: Before and after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Practice. Timepoint: Before and after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Knowledge. Timepoint: Before and after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Food consumption. Timepoint: Before and after intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>BMI (Body Mass Index). Timepoint: Before and after intervention. Method of measurement: Height and weight measurements.</sec_outcome>
      <sec_outcome>WHR (Waist to hip ratio). Timepoint: Before and after intervention. Method of measurement: Waist and hip circumferences.</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>Vice chancellor for research, Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-17</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamadan University of Medical Sciences, Shahid Fahmideh A, Hamadan, Iran Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
