<?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>IRCT20151208025431N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Improve food and nutrition literacy among 10-12 years-old school children of Baneh using Intervention Mapping approach</public_title>
      <acronym></acronym>
      <scientific_title>Development, implementation and evaluation of an intervention to improve food and nutrition literacy among 10-12 years-old school children of Baneh using Intervention Mapping approach</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32094</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Designing a study based on intervention mapping approach which has six steps, Randomization description: Simple Random Cluster Lottery: Randomization is done using a simple random clustering method whose classes include four regions of the north, south, east and west of the city of Baneh   and in each class each school is considered as a cluster, which these clusters, four schools (clusters) will be selected for each region which has two schools (one for boys and one for girls) for the intervention group and two schools (one for boys and one for girls) will also be for the control group. In each district there are 4 schools and in total in the whole city of Baneh, 16 schools will be selected.
Given that the total number of non-profit primary schools is 4 schools whether or not they choose to influence the outcome of the study will not be effective, therefore  to prevent their potential confounding effect, selection of the above schools  abandoned and all elementary state schools that include 48 schools will be selected.
excluded from the selection of these schools and all elementary state schools that include 48 School will be selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Development, implementation and evaluation of an intervention to improve food and nutrition literacy among 10-12 years-old school children of Baneh using Intervention Mapping approach.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Theory-based interventions based on SCT theory and the needs assessments that have been taken before the study begins and the level of food and nutrition literacy, weight and height before intervention and 3 and 6 months after the intervention. Intervention 2: Control group: The control group will not intervene and only level of food and nutrition Literacy , weight and height were measured baseline and 3, 6 months after the 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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ahmadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 76835,Taban Alley10,Shahid Motahari St,Baneh, Kurdistan, Iran</address>
        <city>Baneh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6691776835</zip>
        <telephone>+98 87 3426 6817</telephone>
        <email>moahmadpour5885@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Elham Shakibazeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3333</telephone>
        <email>shakibazadeh@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>10-12 years-old elementary school children of Baneh City which schooling during the study course.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Elementary students over 12 years of age or under 10 years of age</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z55.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other problems related to education and literacy    Inadequate teaching</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Theory-based interventions based on SCT theory and the needs assessments that have been taken before the study begins and the level of food and nutrition literacy, weight and height before intervention and 3 and 6 months after the intervention.</i_keyword>
      <i_keyword>Control group: The control group will not intervene and only level of food and nutrition Literacy , weight and height were measured baseline and 3, 6 months after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve food and nutrition literacy among 10-12 years-old school children of Baneh using Intervention Mapping approach. Timepoint: Measuring food and nutrition literacy  at the beginning of the study ,3 and 6 months after the intervention . Method of measurement: Standard questionnaire.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Measuring weight at the beginning of the study ,3 and 6 months after the intervention . Method of measurement: Digital Sohenle Scale with 100g accuracy.</prim_outcome>
      <prim_outcome>Height. Timepoint: Measuring height at the beginning of the study ,3 and 6 months after the intervention . Method of measurement: Strip meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improve food and nutrition literacy among 10-12 years-old school children. Timepoint: 0,3&amp;6 Month. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Weight. Timepoint: 0,3&amp;6 Month. Method of measurement: Digital Sohenle Scale with 100g accuracy.</sec_outcome>
      <sec_outcome>Height. Timepoint: 0,3&amp;6 Month. Method of measurement: Strip meter.</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>School of Public Health, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-13</approval_date>
        <contact_name>Ethics committee of tehran University of Medical Sciences</contact_name>
        <contact_address>Poursina Street, Quds Ave, Keshavarz Boulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
