<?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>IRCT2013110815318N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-20</date_registration>
      <primary_sponsor>Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dietary and Physical activities counseling on children with metabolic syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effectiveness of  Dietary and Physical Activities Counseling on Components of Metabolic Syndrome in School Age  Children With Metabolic Syndrom</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14597</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>metabolic syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A:&#13;
Children and their parents will be placed in a group based nutrition education program. The training consisted of four consecutive and An interval of one week and Time is 120 minutes.These sessions will be led by the researcher. Intervention 2: Intervention group B:&#13;
Children and their parents will be placed in a group based  Physical activity education program. The training consisted of four consecutive and An interval of one week and Time is 120 minutes.These sessions will be led by the researcher. Intervention 3: Intervention group c:&#13;
Children and their parents will be placed in a group based on both physical activity and nutrition education program .Tutorial sessions for eight consecutive, Twice in a week  and four weeks , time will be 120 minutes .These sessions will be led by the researcher. Intervention 4: The control group: &#13;
 in this period will not be under any kind of formal training (no 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ashraf Alsadat Hakim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 1373 8622</telephone>
        <email>hakim – a@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashraf alsadat hakim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan Autobahn</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 1373 8622</telephone>
        <email>hakim – a@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for intervention:&#13;
1 - Diagnosis of metabolic syndrome defined according to the International Diabetes Federation and the doctor&#13;
2 - The minimum age is 12 years and maximum 6 years&#13;
3 - with the patient and the patient's caregivers Bymarbashd lives.&#13;
4 - Children and parents are willing to participate in the study.&#13;
5 - patients and families who have not previously participated in the training groups.&#13;
6 - no use of drugs affecting lipid metabolism, glucose and blood pressure&#13;
&#13;
Exclusion criteria for intervention:&#13;
   1 - at least not to participate in a training session.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A:&#13;
Children and their parents will be placed in a group based nutrition education program. The training consisted of four consecutive and An interval of one week and Time is 120 minutes.These sessions will be led by the researcher.</i_keyword>
      <i_keyword>Intervention group B:&#13;
Children and their parents will be placed in a group based  Physical activity education program. The training consisted of four consecutive and An interval of one week and Time is 120 minutes.These sessions will be led by the researcher.</i_keyword>
      <i_keyword>Intervention group c:&#13;
Children and their parents will be placed in a group based on both physical activity and nutrition education program .Tutorial sessions for eight consecutive, Twice in a week  and four weeks , time will be 120 minutes .These sessions will be led by the researcher.</i_keyword>
      <i_keyword>The control group: &#13;
 in this period will not be under any kind of formal training (no action)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal obesity (waist Circumference ). Timepoint: Before intervention, Two months after intervention, four months after intervention. Method of measurement: waist Circumference According to cm by Using a height gauge.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Before intervention, Two months after intervention, four months after intervention. Method of measurement: According to Millimeters of mercury and by useing Manometer.</prim_outcome>
      <prim_outcome>Triglycerides. Timepoint: Before intervention, Two months after intervention, four months after intervention. Method of measurement: According to Mg per deciliter by Using blood samples.</prim_outcome>
      <prim_outcome>High-density lipoprotein. Timepoint: Before intervention, Two months after intervention, four months after intervention. Method of measurement: According to Mg per deciliter by Using blood samples.</prim_outcome>
      <prim_outcome>Fast Blood Suger. Timepoint: Before intervention, Two months after intervention, four months after intervention. Method of measurement: According to Mg per deciliter by Using blood samples.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-05</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz Jundishapur University of Medical Science, Golestan Autobahn, Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
