<?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>IRCT20120525009856N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-25</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Economic incentives and weight loss</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of economic motivation on weight reduction women in Kermanshah</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>103</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46063</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention group: In this study, all subjects (103 people) received intervention. Intervention included financial incentives, seasonal diet, nutritional training, and physical activity.Participants were followed for 12 months. For the first 6 months of each month, they were given diet, nutrition, and physical activity training and encouraged if they lost weight. After the end of 6 months, they were asked not to go back and continue the same lifestyle and training they had seen to maintain their weight. Body composition and lipid profile were measured again at 12 months. People who kept their weight constant for six months received financial incentives.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mitra Darbandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3710 2015</telephone>
        <email>m.darbandi@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Yahya Pasdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3826 2005</telephone>
        <email>yahya.pasdar@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age over 30 years
obese women (BMI≥30 kg/m2)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>53 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>pregnant women
People who have been following a special diet  from last 6 months to lose weight</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, all subjects (103 people) received intervention. Intervention included financial incentives, seasonal diet, nutritional training, and physical activity.Participants were followed for 12 months. For the first 6 months of each month, they were given diet, nutrition, and physical activity training and encouraged if they lost weight. After the end of 6 months, they were asked not to go back and continue the same lifestyle and training they had seen to maintain their weight. Body composition and lipid profile were measured again at 12 months. People who kept their weight constant for six months received financial incentives</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Month 1,2,3,4,5,6,12. Method of measurement: in term of kg, by using body analyzer instrumen.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Month 1,2,3,4,5,6,12. Method of measurement: in term of kg/m2, by using body analyzer instrumen.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum Total triglycerides. Timepoint: Month 1,3,6. Method of measurement: by using biochemical kits (Monobind ELISA kit).</sec_outcome>
      <sec_outcome>Serum LDL. Timepoint: Month 1,3,6. Method of measurement: by using Friedewald equation.</sec_outcome>
      <sec_outcome>Serum HDL. Timepoint: Month 1,3,6. Method of measurement: by using biochemical kits (Monobind ELISA kit).</sec_outcome>
      <sec_outcome>Serum total cholostrol. Timepoint: Month 1,3,6. Method of measurement: by using biochemical kits (Monobind ELISA kit).</sec_outcome>
      <sec_outcome>Serum fasting blood sugar. Timepoint: Month 1,3,6. Method of measurement: by using biochemical kits (Monobind ELISA kit).</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-02</approval_date>
        <contact_name>Kermanshah University of Medical Sciences, Kermanshah, Iran</contact_name>
        <contact_address>Deputy of Research and Technology, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
