<?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>IRCT2016070228747N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-02</date_registration>
      <primary_sponsor>Vice chancellor for research, Gonabad university of medical sciences</primary_sponsor>
      <public_title>Effects of a Training Program on the Control of Overweight and Obesity.</public_title>
      <acronym>-</acronym>
      <scientific_title>Effects of a Participatory Training Program on the Control of Overweight and Obesity in Female Adolescents.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23236</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: After screening the eligible (with inclusion criteria) participants were randomly assigned to the control and the intervention group. For this purpose four schools were selected randomly among of all the schools and then randomly two in control group and the two others in intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity and Overweight.</hc_freetext>
      <i_freetext>Intervention 1: Interventions group: Training program was designed by the researcher on proper nutritional behaviors, balanced physical activity and nutritional counseling. The program was reinforced by educational aid tools and lecture and group discussion procedures. This program was performed in weekly one-hour session for six weeks. Intervention 2: Control group: In the control group no intervention was conducted.</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>Marjan Mirzania</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 5027</telephone>
        <email>m.mirzania2025@gmail.com; m.mirzania4910@gmail.com; mirzania.m@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marjan Mirzania</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gonabad University of Medical Sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 5027</telephone>
        <email>m.mirzania2025@gmail.com; m.mirzania4910@gmail.com; mirzania.m@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being girl; 12 to 14 years old; Being obese or overweight based on WHO references; Willing to participate by the side of each participant and her family; Without any disability. Exclusion criteria: Absence in more than one session of education.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>14 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Simple obesity NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions group: Training program was designed by the researcher on proper nutritional behaviors, balanced physical activity and nutritional counseling. The program was reinforced by educational aid tools and lecture and group discussion procedures. This program was performed in weekly one-hour session for six weeks.</i_keyword>
      <i_keyword>Control group: In the control group no intervention was conducted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Overewight. Timepoint: Immediately before intervention and two month after intervention. Method of measurement: Weight was measured (with participant in socks with no shoes and wearing a light gown) to the nearest 0.5 kg using a medical weight scale, zeroed and calibrated before each weight. A stadiometer calibrated in 0.5 cm intervals, was used to measure the height in bare foot, while the feet sticking together and the knees, hip, shoulder, and back were aligned with a vertical line. Their BMI was also calculated (weight in kilograms divided by the square of the height in meters).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Obesity. Timepoint: Immediately before intervention and two month after intervention. Method of measurement: Weight was measured (with participant in socks with no shoes and wearing a light gown) to the nearest 0.5 kg using a medical weight scale, zeroed and calibrated before each weight. A stadiometer calibrated in 0.5 cm intervals, was used to measure the height in bare foot, while the feet sticking together and the knees, hip, shoulder, and back were aligned with a vertical line. Their BMI was also calculated (weight in kilograms divided by the square of the height in meters).</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, Gonabad university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-15</approval_date>
        <contact_name>Ethics committee of Gonabad university of medical sciences</contact_name>
        <contact_address>Gonabad university of medical sciences, next to the Asian road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of. Gonabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
