<?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>IRCT2017081935772N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-12</date_registration>
      <primary_sponsor>Vice Chancellor for research of Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention on BMI and thyroid function test</public_title>
      <acronym>-</acronym>
      <scientific_title>The effect of educational intervention on body mass index and thyroid function tests in children and adolescents with obesity or overweight</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26936</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, the areas in Birjand were initially arranged based on school distribution, later, the elementary levels, middle schools, and high schools in each area were classified and divided into clusters, then, the random samples of each cluster were systematically selected from obese children and adolescents who had health records in Atherosclerosis and Coronary Artery Research Center. Assignment of samples to the two groups (control and intervention) is non-random.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Thyroid disorders. Condition 2: Obesity and overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, the training was lectured with PowerPoint for parents, children, and adolescents in six meetings (every month, one meeting) which included the following subjects: obesity definition and its disadvantage in childhood and adulthood; the importance and benefits of weight control; recommendations and necessary actions for weight control, lifestyle modification, healthy diet, physical activity, and parental attitudes towards children. This intervention was 6 months. Intervention 2: Control group:&#13;
In the control group, educational intervention is not performed.</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>Dr. Neda Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari Ave., Birjand, Iran</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3223 2895</telephone>
        <email>neda.ebrahimi@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Neda Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics, Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari Ave., Birjand, Iran</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3223 2895</telephone>
        <email>neda.ebrahimi@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
The children and adolescents with overweight and obesity (BMI above 85% percentile);&#13;
Non-syndromic children and adolescents with an age range of 7 to 18 years;&#13;
The parental informed consent.&#13;
Exclusion criteria:&#13;
The children who had a medical history using radioactive iodine (radioiodine), thyroid hormones, and antithyroid drugs or any medication, that may affect thyroid;&#13;
The children with a known type of endocrine or metabolic abnormalities; &#13;
Students with lack of the parental consent.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E00, E01, </hc_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of thyroid gland</hc_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, the training was lectured with PowerPoint for parents, children, and adolescents in six meetings (every month, one meeting) which included the following subjects: obesity definition and its disadvantage in childhood and adulthood; the importance and benefits of weight control; recommendations and necessary actions for weight control, lifestyle modification, healthy diet, physical activity, and parental attitudes towards children. This intervention was 6 months.</i_keyword>
      <i_keyword>Control group:&#13;
In the control group, educational intervention is not performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body mass Index (BMI). Timepoint: 6 months before and 6 months after of intervention. Method of measurement: Measuring of weight and height and calculate BMI according to a formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Thyroid function tests. Timepoint: 6 months before and 6 months after of intervention. Method of measurement: Blood test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>884</sec_id>
        <issuing_authority>Birjand University of Medical Sciences</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for research of Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-21</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Department of pediatrics, Faculty of Medicine, Birjand University of Medical Sciences (BUMS), Ghaffari avenue Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
