<?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>IRCT20221211056776N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-13</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of nutritional education in the fourth, fifth and sixth grade of elementary school students to reduce the consumption of unhealthy snacks</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of theory-based educational intervention on consumption of healthy snacks in elementary students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69573</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Cluster randomization method will be used. In this way, 2 schools will be assigned as intervention and two schools will be assigned as control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Consumption of healthy snacks in elementary students.</hc_freetext>
      <i_freetext>Intervention 1: Direct training with questions &amp; answers in the intervention group for four weeks. Intervention 2: Control group: without action.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>bahareh amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar Boulevard, Qazvin, Iran, Qazvin University of Medical Scincese</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3335 9504</telephone>
        <email>rataarya@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hadi Morshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Scincese, Shahid Bahonar Boulevard, Qazvin, Iran</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3335 9504</telephone>
        <email>hmorshedi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being students in the fourth, fifth and sixth grades of elementary school who live in the study area
Willingness and satisfaction of students and their parents to participate in the study
Being in the three stages of preparation for change, i.e. pre-thinking, thinking and preparation (according to the answers given to the algorithm of the stages of change)
Having a smart mobile phone by the student or parents to send educational messages or virtual training if needed</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participating in the study
Unavailability of the student when completing the post-test questionnaire (immigration during the research).
Suffering from physical and mental disorders and diseases that somehow prevent proper participation in the study. (Certified by a physician).</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>Direct training with questions &amp; answers in the intervention group for four weeks</i_keyword>
      <i_keyword>Control group: without action</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stages of behavior change. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>The process of behavior change. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Cognitive process. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Knowledge. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Dramatic relief. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>. Timepoint: . Method of measurement: .</prim_outcome>
      <prim_outcome>Social release. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Reciprocal conditioning. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Supportive relationships. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Balance in decision making. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Eﬃcacy. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Consumption of healthy snacks. Timepoint: Consumption of healthy snacks. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Parents' education. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Parents'jop. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Age. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Sex. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Student's weight. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Number of household dimensions. Timepoint: Before the intervention, one months after the intervention. Method of measurement: Questionnaire.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-18</approval_date>
        <contact_name>Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
