<?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>IRCT2014051017639N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-13</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan University of Medical Science</primary_sponsor>
      <public_title>Nutrition education among obese adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effectiveness of  theory-based Educational intervention program and common education on anthropometric parameters, biochemical and blood pressure in  obese adolescents.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16170</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: After screening the eligible participants were randomly assigned to the control group or the intervention group by simple randomization. In this case, all of the 100 participants numbered from 1 to 100 and divided in two groups based on odds and even numbers. Then, by coin toss the participants with odds number were considered as intervention group and the participants with even number were considered as control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity in adolescents.</hc_freetext>
      <i_freetext>Intervention 1: Intervention1: Educational intervention based on education model (HBM)  &#13;
The intervention group (n=46) participated in 12 educational sessions (one session/week) including educational lecture, group discussion, question-answer, pamphlet, booklet, power-point slide show on physical activity and its advantages, obesity and its consequences, susceptibility of obese people to cardiovascular disease and diabetes and healthy eating key-points based on the food guide pyramid. Intervention 2: Intervention 2: The control group was assigned a usual program which included simple recommendations to reduce the intake of energy-dense foods such as fried foods, fast foods, cream, sugar and soft drinks in their diet and increasing the consumption of vegetables and fruits  and doing more physical activity.</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>Mojgan Nourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Hezar Jerib Avenue, Isfahan University of Medical Sciences, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2671</telephone>
        <email>nourian@hlth.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Science/Nutrition Department</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Nourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Hezar Jerib Avenue, Isfahan University of Medical Sciences, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2671</telephone>
        <email>nourian@hlth.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria&#13;
•	Age between 12–18 years&#13;
•	Overweight or obese (BMI in the 85th–95th percentile or ≥95th percentile for age and sex)&#13;
•	Abdominal obesity (waist circumference ≥90th percentile for age and sex based on waist circumference cut-offs for Iranian children and adolescents)&#13;
&#13;
Exclusion criteria &#13;
•	History of diabetes and/or cardiovascular disease &#13;
•	Disease of the liver or any endocrine organ&#13;
•	Use of medication affecting serum lipids and serum glucose level &#13;
•	Following any prescribed diet and/or exercise program in the 6 months prior to the study</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>17 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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention1: Educational intervention based on education model (HBM)  &#13;
The intervention group (n=46) participated in 12 educational sessions (one session/week) including educational lecture, group discussion, question-answer, pamphlet, booklet, power-point slide show on physical activity and its advantages, obesity and its consequences, susceptibility of obese people to cardiovascular disease and diabetes and healthy eating key-points based on the food guide pyramid.</i_keyword>
      <i_keyword>Intervention 2: The control group was assigned a usual program which included simple recommendations to reduce the intake of energy-dense foods such as fried foods, fast foods, cream, sugar and soft drinks in their diet and increasing the consumption of vegetables and fruits  and doing more physical activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dietary intake-physical activity. Timepoint: Before the intervention, at 3 months after the intervention and 3 months after the end of the intervention. Method of measurement: Food record Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Biochemical measurements, Blood Pressure, waist circumference. Timepoint: Before of the intervention, at 3 months after the intervention  and 3 months after the end of the intervention. Method of measurement: Enzymatic method, kit (Parsazmoon), immunoturbidimetric method using Rondex commercially kit, Sphygmomanometer-Tape.</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>Vice chancellor for research, Isfahan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-08-20</approval_date>
        <contact_name>Ethics committee of UPM university in Malaysia</contact_name>
        <contact_address>UPM university in Malaysia Selangor Selangor Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
