<?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>IRCT138706091126N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-17</date_registration>
      <primary_sponsor>Guilan University of Medical Sciences</primary_sponsor>
      <public_title>A Comparative effect of Child-to-Child and Health Educator to-Child teaching approaches on nutritional status in Elementary School Students in Rasht, 2014</public_title>
      <acronym>Effect of Child Education on nutrition</acronym>
      <scientific_title>A Comparative effect of Child-to-Child and Health Educator to-Child teaching approaches on nutritional status in Elementary School Students in Rasht, 2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>450</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/159</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Malnutrition.</hc_freetext>
      <i_freetext>Intervention 1: This is across-sectional and quasi experimental-interventional study.Samples were chosen by random-cluster sampling modelthrough which 450 students are selected from third, fourth and fifth grades from elementary schools of different districts of Rasht. The number of sample (sample size) is used to determinethe favorable and unfavorable food frequency. Data-collection tools consist of demographic questionnaire (parents' level of education, age, sex, economic situation and weight)and FFQ (food frequency questionnaire or checklist) with 54 items onsnacks. Before the intervention, the questionnaire is completed by the researcher and mother during one week and after gathering them, the items of questionnaire (checklist) will be summed upfor determining the favorable and unfavorable food frequency. This means that 54 items of authorized and unauthorized snack-foods with a variety of four main groups of food pyramid have been listed. If each student consumes 28 items of the authorized snack-foods during one week or consumes the other authorized snack-foods with the same nutritional value and a variety of four main food groups for seven times or more, she/hewill obtain 0.5 points, and if the diversity of snack-foods is not met or the students consume the unauthorized ones, they will obtain point zero. The total score for the authorized snack-foods is 14. According to the score of food frequency, the students are divided intodesirable (favorable) and undesirable (unfavorable) groups using random method. In the first group, the subjects who obtain 14 points or more for the food frequencyhave the favorable frequency which they will not be entered in the educational intervention. In the second group, the subjects who obtain a score less than 14are categorized as unfavorable frequency which they are qualified to enter the educational intervention. From 450 students with the unfavorable frequency, 174 students are selected and divided into three groups (58 students for the first group or the child-to-child group, 58 students for the second group of the health educator-to-child group and 58 students for the third group or control group). First and second groups will receive educational intervention but the third or controlgroup will get no teaching intervention.&#13;
&#13;
Some of thelittle educators will be selected for each level of studies regarding the highest score in the questionnaire (checklist) and the comments of school masters and principlesin order to recognize the student with a good rhetoric. A training course for the little educators and the health care providers will be held by the researcher (by using pamphlets, booklets and posters) at one of the schools during three sessions. Three training sessions (for 30 minutes) with the subjects about the authorized and unauthorized snack-foods, micronutrient, the role each of them plays and the fruit festival will be held for each level of studiesby the child-to-child and the educator-to-child groups at one of the school in the afternoon. There is no training course for the control group. After three weeks, a questionnaire (observation checklist) is completed by the researcher and mother during one week, which the research and mother's information will be gathered at the end of the week. Finally, the score of the food frequency will be favorably and unfavorably computed according to the determined points. The reliability and validity of the feed frequency questionnaire (checklist) was examined by the FFQ Questionnaire of Mirmiranet al. (2009) at Tehran University of Medical Sciences (TUMA). This study's FFQ results can lead to an acceptable reliability and validity for most food groups. Intervention 2: Department of Child-to-child education, peer-to-child child in three 30-minute sessions in the school.&#13;
The third, fourth and fifth classes have 58 students. Intervention 3: Group training coach children for three 30-minute sessions health educator to students in school.&#13;
The third, fourth and fifth classes have 58 students. Intervention 4: Education and other intervention control group that did not take place on students&#13;
&#13;
And the number 58 in the third and fourth classes and fifth respectively.</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>Nasrin Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwiffery school, Daneshjo st., Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 3202</telephone>
        <email>Lakeh@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwiffery school, Daneshjo st., Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 3202</telephone>
        <email>Lakeh@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclution criteria : third, fourth and fifth grades from elementary schools and completing consents,parents&#13;
&#13;
Exclution criteria :Except for the above that is exclution creteria</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E40-46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malnutrition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This is across-sectional and quasi experimental-interventional study.Samples were chosen by random-cluster sampling modelthrough which 450 students are selected from third, fourth and fifth grades from elementary schools of different districts of Rasht. The number of sample (sample size) is used to determinethe favorable and unfavorable food frequency. Data-collection tools consist of demographic questionnaire (parents' level of education, age, sex, economic situation and weight)and FFQ (food frequency questionnaire or checklist) with 54 items onsnacks. Before the intervention, the questionnaire is completed by the researcher and mother during one week and after gathering them, the items of questionnaire (checklist) will be summed upfor determining the favorable and unfavorable food frequency. This means that 54 items of authorized and unauthorized snack-foods with a variety of four main groups of food pyramid have been listed. If each student consumes 28 items of the authorized snack-foods during one week or consumes the other authorized snack-foods with the same nutritional value and a variety of four main food groups for seven times or more, she/hewill obtain 0.5 points, and if the diversity of snack-foods is not met or the students consume the unauthorized ones, they will obtain point zero. The total score for the authorized snack-foods is 14. According to the score of food frequency, the students are divided intodesirable (favorable) and undesirable (unfavorable) groups using random method. In the first group, the subjects who obtain 14 points or more for the food frequencyhave the favorable frequency which they will not be entered in the educational intervention. In the second group, the subjects who obtain a score less than 14are categorized as unfavorable frequency which they are qualified to enter the educational intervention. From 450 students with the unfavorable frequency, 174 students are selected and divided into three groups (58 students for the first group or the child-to-child group, 58 students for the second group of the health educator-to-child group and 58 students for the third group or control group). First and second groups will receive educational intervention but the third or controlgroup will get no teaching intervention.&#13;
&#13;
Some of thelittle educators will be selected for each level of studies regarding the highest score in the questionnaire (checklist) and the comments of school masters and principlesin order to recognize the student with a good rhetoric. A training course for the little educators and the health care providers will be held by the researcher (by using pamphlets, booklets and posters) at one of the schools during three sessions. Three training sessions (for 30 minutes) with the subjects about the authorized and unauthorized snack-foods, micronutrient, the role each of them plays and the fruit festival will be held for each level of studiesby the child-to-child and the educator-to-child groups at one of the school in the afternoon. There is no training course for the control group. After three weeks, a questionnaire (observation checklist) is completed by the researcher and mother during one week, which the research and mother's information will be gathered at the end of the week. Finally, the score of the food frequency will be favorably and unfavorably computed according to the determined points. The reliability and validity of the feed frequency questionnaire (checklist) was examined by the FFQ Questionnaire of Mirmiranet al. (2009) at Tehran University of Medical Sciences (TUMA). This study's FFQ results can lead to an acceptable reliability and validity for most food groups.</i_keyword>
      <i_keyword>Department of Child-to-child education, peer-to-child child in three 30-minute sessions in the school.&#13;
The third, fourth and fifth classes have 58 students.</i_keyword>
      <i_keyword>Group training coach children for three 30-minute sessions health educator to students in school.&#13;
The third, fourth and fifth classes have 58 students.</i_keyword>
      <i_keyword>Education and other intervention control group that did not take place on students&#13;
&#13;
And the number 58 in the third and fourth classes and fifth respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Education. Timepoint: A week before, a week after the intervention, three weeks after. Method of measurement: Food Frequency Questioner.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nutrition Status. Timepoint: A week before, a week after the intervention, three weeks after. Method of measurement: Food Frequency Questioner.</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>Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-24</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Guilan University of Medical Sciences, in front of Sepah Bank, West Beheshti blvd., Rasht Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
