<?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>IRCT2013103115211N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-11-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sceineces</primary_sponsor>
      <public_title>The effect of of nutrition and physical activity education on nutrition and exercise behaviors  weight in overweight and obese adolescents.</public_title>
      <acronym>SCT: Social cognitive theory</acronym>
      <scientific_title>Study on the Effect of Nutrition Education and Physical Activity intervention using Social Cognitive Theory  for Overweight and Obese Student Girls of Middle School of Shahinshahr.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14540</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: students and their parents will be taught about nutrition and physical activity with participating in theory and practical seminars, conferences and workshops (12 sessions and each session 60 minutes). In addition, 6 sessions will be held for Individual Counseling about nutrition and physical activity for students (each session 60 minutes). Other parts of education are comprised from sending 48 messages for students and their parents, educational CD and holding practical exercise classes for students (40 sessions and each session 90 minutes). All interventions will be done in 6 months. Intervention 2: Control group: During study no intervention will be done in control group. but after that, four education sessions will be held in control group for students and their parents. (each session will be 90 minutes ).</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>Mohamad Bagherniya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8897 4463</telephone>
        <email>m_bagherniya@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sceineces</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Ali Keshavarz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No6, Poursina St, 16th-azar St, Keshavarz Blv, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8897 4463</telephone>
        <email>s_akeshavarz@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Second and third grade female students in middle schools who according to the WHO 2007 Tables have Body Math Index  above the 85th percentile; Student's age are between 12 to 16 years; Students do not have any of the exclusion criteria.&#13;
 Exclusion criteria: Using drugs which associated with overweight and obesity, such as nerve drugs, corticosteroids and so on; Received and followed any diet by students for losing weight before the study; Students who have any Metabolic diseases such as endocrine disorders, thyroid disease, diabetes and so on.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>16 years</agemax>
      <gender>Female</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: students and their parents will be taught about nutrition and physical activity with participating in theory and practical seminars, conferences and workshops (12 sessions and each session 60 minutes). In addition, 6 sessions will be held for Individual Counseling about nutrition and physical activity for students (each session 60 minutes). Other parts of education are comprised from sending 48 messages for students and their parents, educational CD and holding practical exercise classes for students (40 sessions and each session 90 minutes). All interventions will be done in 6 months.</i_keyword>
      <i_keyword>Control group: During study no intervention will be done in control group. but after that, four education sessions will be held in control group for students and their parents. (each session will be 90 minutes )</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Before intervention, three months after starting intervention, at the end, after intervention. Method of measurement: digital scale.</prim_outcome>
      <prim_outcome>Height. Timepoint: Before intervention, three months after starting intervention, at the end, after intervention. Method of measurement: height gauge.</prim_outcome>
      <prim_outcome>Body Math Index. Timepoint: Before intervention, three months after starting intervention, at the end, after intervention. Method of measurement: wieght/height2.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Before intervention, three months after starting intervention, at the end, after intervention. Method of measurement: non-elastic flexible tape.</prim_outcome>
      <prim_outcome>Nutritional behavior. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Physical activity behavior. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Nutrition self efficacy. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Physical activity self efficacy. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived social support in nutrition. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived social support in physical activity. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Outcome expectation in nutrition. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Outcome expectation in physical activity. Timepoint: Before intervention and after intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Department of Education of Shahinshahr city</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 Sceineces</source_name>
      <source_name>Department of Education of Shahinshahr city</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-11-19</approval_date>
        <contact_name>Vice-Chancellor for Research, Tehran University of Medical Sciences</contact_name>
        <contact_address>4th fl, Main Organization of Tehran University of Medical Sciences, Qods corner, Keshavarz Blv, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
