<?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>IRCT2016110530707N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-22</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24315</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each adolescent will be recruited at the pediatric clinic to which they referred for treatment. Randomization will be performed after checking eligibility criteria, signing of informed consent, and baseline assessment. An independent biostatistician will randomize  the adolescents into two groups (CBT and TAU) using software program  and stratifying with the pediatric clinics.</study_design>
      <phase>2-3</phase>
      <hc_freetext>overweight or obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive behavioral therapy (CBT) will be used in this study. Intervention group will receive CBT consisted of six weekly, face to face sessions. Intervention 2: Control group: This group will not receive any treatment during the study.they will receive counseling sessions at the end of study similar to intervention group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Fatemeh Miri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin  Medical University, Shahid Bahoonar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>59811-34197</zip>
        <telephone>+98 28 3337 4872</telephone>
        <email>f.miri@qums.ac.ir</email>
        <affiliation>Qazvin Medical Science University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir H Pakpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Social Determinants of Health Research Center</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3323 9259</telephone>
        <email>Pakpour_amir@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age 13–18 years
BMI ≥85th percentile for age and gender
ability to attend CBT sessions</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cushing Disease
hypoparathyroidism
being pregnant
having clinical mental health conditions or psychosis, taking specific medications that affected their weight
participating in another weight loss RCT</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E65, E66, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity and other hyperalimentation   / 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>Intervention group: Cognitive behavioral therapy (CBT) will be used in this study. Intervention group will receive CBT consisted of six weekly, face to face sessions.</i_keyword>
      <i_keyword>Control group: This group will not receive any treatment during the study.they will receive counseling sessions at the end of study similar to intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: before intervention and after 6 month. Method of measurement: balance scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body mass index. Timepoint: before and after intervention. Method of measurement: weigh(kg)/(height)2.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: baseline and 6 month after intervention. Method of measurement: meter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: at baseline and 6 month after intervention. Method of measurement: meter.</sec_outcome>
      <sec_outcome>Energy intake. Timepoint: at baseline and 6 month after intervention. Method of measurement: food frequency questionnair.</sec_outcome>
      <sec_outcome>Physical activity. Timepoint: at baseline and 6 month after intervention. Method of measurement: physical activity questionnair.</sec_outcome>
      <sec_outcome>Health-related quality of life. Timepoint: at baseline and 6 month after intervention. Method of measurement: quality of life questionnaire.</sec_outcome>
      <sec_outcome>Self efficacy. Timepoint: at baseline and 6 month after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Body composition. Timepoint: at baseline and 6 month after intervention. Method of measurement: body analyser.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-19</approval_date>
        <contact_name>Qazvin Medical Science University Ethics committee</contact_name>
        <contact_address>Medical Science University, Shahid Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
