<?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>IRCT2013012412255N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>prevention and control of obesity in primary school children in Tehran</public_title>
      <acronym></acronym>
      <scientific_title>Developing and evaluating of  an interventional model to prevent and control childhood obesity in the fifth-graders. Tehran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>360</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12351</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>overweight/obesity.</hc_freetext>
      <i_freetext>Intervention 1: The approach of intervention is knowledge translation. The intervention will be multi-component  including nutrition education (parents and students), increased physical activity, and changing of the schools, environment. The education will be monthly and weekly sessions for parents and students, respectively. The parents are taught about childhood obesity and its causes. They will also learn strategies to increase physical activity and vegetable and fruit consumption, as well as decrease consumption of high energy foods by their children.Nutrition education of the students will be done done by health instructors of the schools who have been trained for this work. The content of the education will be mainly Iranian food pyramid, food groups, and energy value of the food groups. To increase physical activity of the students,  weekly exercise sessions under supervision of their schools’ coach will be done in schools. Finally, the school canteens will becolsely supevised with particular attention to the type of foods (snacks, etc.) offered for sale. Intervention 2: During the intervention period nothing will be done in comparison schools. At the end of intervention an educational session for parents(1.5 h) will be held for all comparison schools.</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>Maryam Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition &amp; Biochemistry, School of Public Health, Poursina Ave., Qods Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6640 2095</telephone>
        <email>mamini@razi.tums.ac.ir</email>
        <affiliation>Department of Community Nutrition, School of Nutrition &amp; Dietetics, Tehran University of Medical Sci</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Abolghassem Djazayery</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutrition &amp; Biochemistry, School of Health, Poursina Ave., Qods Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6640 2095</telephone>
        <email>jazaiers@tums.ac.ir</email>
        <affiliation>Department of Community Nutrition, School of Nutrition and Dietetics, Tehran University of Medical S</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Incusion criteria: BMI-Z-Score &gt; or =1(WHO), students in the fifth or sixth grades&#13;
Exclusion criteria: metabolic disorders (hypo or hyperthyroidisim), any disease which interfere with adherence to the intervention, intake of any appetite-reducing drug, doing professional sports, being on a weight reduction diet</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The approach of intervention is knowledge translation. The intervention will be multi-component  including nutrition education (parents and students), increased physical activity, and changing of the schools, environment. The education will be monthly and weekly sessions for parents and students, respectively. The parents are taught about childhood obesity and its causes. They will also learn strategies to increase physical activity and vegetable and fruit consumption, as well as decrease consumption of high energy foods by their children.Nutrition education of the students will be done done by health instructors of the schools who have been trained for this work. The content of the education will be mainly Iranian food pyramid, food groups, and energy value of the food groups. To increase physical activity of the students,  weekly exercise sessions under supervision of their schools’ coach will be done in schools. Finally, the school canteens will becolsely supevised with particular attention to the type of foods (snacks, etc.) offered for sale.</i_keyword>
      <i_keyword>During the intervention period nothing will be done in comparison schools. At the end of intervention an educational session for parents(1.5 h) will be held for all comparison schools.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>BMI. Timepoint: before and 6 month after the intervention. Method of measurement: weight by digital scalem height by stadiometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Waist an hip circumferences. Timepoint: Before and 6 months after the intervention. Method of measurement: Tape meter.</sec_outcome>
      <sec_outcome>Triceps skinfold. Timepoint: Before and 6 months after the intervention. Method of measurement: Caliper.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: Before and 6 months after the intervention. Method of measurement: Standardized questionnaire.</sec_outcome>
      <sec_outcome>Energy intake. Timepoint: Before and 6 months after the intervention. Method of measurement: 24 h food recall.</sec_outcome>
      <sec_outcome>Daily total fat intake. Timepoint: Before and 6 months after the intervention. Method of measurement: 24-h food recall.</sec_outcome>
      <sec_outcome>Percentage of energy from fat. Timepoint: Before and 6 months after the intervention. Method of measurement: 24-h food recall.</sec_outcome>
      <sec_outcome>Total daily intake of  carbohydrate. Timepoint: Before and 6 months after the intervention. Method of measurement: 24-h food recall.</sec_outcome>
      <sec_outcome>Percentage of energy from carbohydrate. Timepoint: Before and 6 months after the intervention. Method of measurement: 24-h food recall.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Ministry of Health and Medical Education</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Ministry of Health and Medical Education</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-04-15</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>P.O.Box 14155-6446, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
