<?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>IRCT20190822044580N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-19</date_registration>
      <primary_sponsor>Medical University of Yazd</primary_sponsor>
      <public_title>The Effectiveness of Reality Therapy Based on Choice Theory along with diet Therapy on lose weight of over weight People</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Reality Therapy Based on Choice Theory along with diet Therapy on Biochemical Indicators in Obese People: The Mediating Role of Bipolar Thinking and Body Image</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41758</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects from one to fifty were assigned to A and B and then divided into two groups: intervention and control with random allocation software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Overweight and obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Reality Therapy according to the protocol specified by Psychologist for 8 sessions in the first three weeks of study combined with Low calorie diet that reduced 500 calorie per person by Nutritionist. Intervention 2: Control group:Nutritionist gave Low calorie diet with 500 calorie limitation per person.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data obtained for this study are available in journals

When:
This data is presented as an article by the end of the year 2020

To whom:
This data will be only available to researchers working in academia

Conditions:
The data in this study are only authorized with the permission of the design of other statistical analyzes

Where to obtain:
reza eftekhar
email: rezaeft.nut@gmail.com
cellphone number:00989150406372

How to obtain:
Just send an email with full specifications of individual expression. you need 48 hours for getting data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hassan Mozaffari Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd University of Medical Sciences Building</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>009838367636</telephone>
        <email>mozaffari.kh@gmail.com</email>
        <affiliation>Medical University of Yazd</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Mozaffari Khosravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoghi, Yazd University of Medical Sciences Building</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916978477</zip>
        <telephone>+98 35 3836 7636</telephone>
        <email>mozaffari.kh@gmail.com</email>
        <affiliation>Medical University of Yazd</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 18 to 65
body mass index between 25 to 35
individuals don't use drugs that increasing apetite
individual hasn't use drug or supplement for two month ago
individual hasn't  do bariatric surgery
individual has not been pregnancy or lactation
He/She had dichotomous thinking
He/She had body image disorder</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>depression disorder
personality disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Reality Therapy according to the protocol specified by Psychologist for 8 sessions in the first three weeks of study combined with Low calorie diet that reduced 500 calorie per person by Nutritionist</i_keyword>
      <i_keyword>Control group:Nutritionist gave Low calorie diet with 500 calorie limitation per person</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dichotomous Thinking Scale in Dichotomous Thinking Questionnaire. Timepoint: "Measuring Dichotomous thinking at the beginning of the study (before the intervention) and at the end of the reality therapy intervention". Method of measurement: Dichotomous Thinking Questionnaire.</prim_outcome>
      <prim_outcome>Body Image Scale in Body Image Concern Inventory Questionnaire. Timepoint: "Measuring  Body Image Concern Inventory at the beginning of the study (before the intervention) and at the end of the reality therapy intervention". Method of measurement: Body Image Concern Inventory Questionnaire.</prim_outcome>
      <prim_outcome>Individuals body weight. Timepoint: measuring of body weight in 1, 4, 11 weeks. Method of measurement: By using inbody device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>High-density lipoprotein. Timepoint: High-density lipoprotein levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>Low-density lipoprotein. Timepoint: low-density lipoprotein levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>Cholesterol. Timepoint: cholesterol levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: triglyceride levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>High-sensitivity C-reactive protein. Timepoint: high-sensitivity C-reactive protein levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: fasting blood sugar levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>Complete blood count. Timepoint: Complete blood count levels were measured before and after the study. Method of measurement: Using approved kits and cell counter.</sec_outcome>
      <sec_outcome>Aspartate Aminotransferase. Timepoint: Aspartate Aminotransferase levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>Alanin Aminotransferase. Timepoint: Alanin Aminotransferase levels were measured before and after the study. Method of measurement: outoanalyzer bt3000.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: hip circumference were measured before, middle and after the study. Method of measurement: By using inbody device.</sec_outcome>
      <sec_outcome>Abdomen circumference. Timepoint: abdomen circumference were measured before, middle and after the study. Method of measurement: By using inbody device.</sec_outcome>
      <sec_outcome>Body fat mass. Timepoint: body fat mass were measured before, middle and after the study. Method of measurement: By using inbody device.</sec_outcome>
      <sec_outcome>Free fat mass. Timepoint: free fat mass were measured before, middle and after the study. Method of measurement: By using inbody device.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: body mass index were measured before, middle and after the study. Method of measurement: By using inbody device.</sec_outcome>
      <sec_outcome>Total Body Water. Timepoint: Total Body Water were measured before, middle and after the study. Method of measurement: By using inbody device.</sec_outcome>
      <sec_outcome>Minerals. Timepoint: minerals were measured before, middle and after the study. Method of measurement: By using inbody device.</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>thesis master degree</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-21</approval_date>
        <contact_name>Ethics committee school of Public Health-Shahid Sadoghi University of Medical Sciences</contact_name>
        <contact_address>Shahid Sadoughi Blvd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
