<?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>IRCT2015120525368N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-15</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of diet on prevention of gestational diabetes mellitus</public_title>
      <acronym></acronym>
      <scientific_title>Effect of a low glycaemic index(LGI) diet on anthropometric measurements, glycaemia index and lipid profile in high risk pregnancy women for gestational diabetes mellitus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention of gestational diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: High risk pregnancy women for gestational diabetes mellitus  in intervention  group fall under low glycaemic index diet .Taught them what categories of foods low glycaemic index and how can replace foods with a low glycaemic index. During the intervening two months. Intervention 2: Pregnant women in the control group receive training and regular prenatal care and consultations are about food needed during pregnancy. During the intervening two months.</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>Ziba Kojori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences, School of Nutrition and Food Sciences, Razi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71756-78438</zip>
        <telephone>+98 71338235689</telephone>
        <email>zibakojori_2015@yahoo.comk.j_zb@yahoo.com</email>
        <affiliation>School Of Nutrition and Food Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Zohreh Mazloom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz University of Medical Sciences, School of Nutrition and Food Sciences, Razi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3626 3132</telephone>
        <email>zohreh.mazloom@gmail.com</email>
        <affiliation>School of Nutrition and Food Sciense</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: pregnant women with age greater than 18 years and gestational age less than 16 weeks; pregnant women with BMI&gt;27 kg/m2 and Having at leas one criterion of the risk factors for gestational diabetes: history of type 2 diabetes in first-degree relatives; previous history of gestational diabetes mellitus; History of birth weight more than 4 kg; Maternal age greater than 30 years .Exclusion criteria: Smoking and alcohol consumption; special diet; Specific drug consumption; diabetes; gestational diabetes mellitus; Impaired glucose tolerance; hypothyroidism; hyper tension</inclusion_criteria>
      <agemin>76 years</agemin>
      <agemax>1 year</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>024.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus in pregnancy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>High risk pregnancy women for gestational diabetes mellitus  in intervention  group fall under low glycaemic index diet .Taught them what categories of foods low glycaemic index and how can replace foods with a low glycaemic index. During the intervening two months.</i_keyword>
      <i_keyword>Pregnant women in the control group receive training and regular prenatal care and consultations are about food needed during pregnancy. During the intervening two months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: Before intervention and two months after intervention. Method of measurement: Blood test and measuring fasting blood glucose.</prim_outcome>
      <prim_outcome>Measure blood glucose one hour and two and three hours after feeding 100 g of glucose. Timepoint: Two months after intervention. Method of measurement: Performance OGTT.</prim_outcome>
      <prim_outcome>Fasting serum insulin. Timepoint: Before intervention and two months after intervention. Method of measurement: Blood test and measuring INS.</prim_outcome>
      <prim_outcome>Calculate Body Mass Index(BMI). Timepoint: Before intervention. Method of measurement: Ratio of weight in kg to the square of height in m2.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measure  weight. Timepoint: Before intervention and two months after intervention. Method of measurement: Digital weighing scales.</sec_outcome>
      <sec_outcome>Measure  height. Timepoint: Before intervention and two months after intervention. Method of measurement: Measured using the wall mounted stadiometer.</sec_outcome>
      <sec_outcome>Measure systolic and diastolic blood pressure. Timepoint: Before intervention and two months after intervention. Method of measurement: Blood pressure measuring device.</sec_outcome>
      <sec_outcome>Assessment of dietary intake. Timepoint: Before intervention , one months after  and two months after intervention. Method of measurement: 3-Day dietary records.</sec_outcome>
      <sec_outcome>Measure total cholesterol. Timepoint: Before intervention and two months after intervention. Method of measurement: Blood test and measuring TC.</sec_outcome>
      <sec_outcome>Measure cholesterol LDL and HDL. Timepoint: Before intervention and two months after intervention. Method of measurement: Blood test and measuring LDL and HDL.</sec_outcome>
      <sec_outcome>Measure triglyceride. Timepoint: Before intervention and two months after intervention. Method of measurement: Blood test and measuring TG.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-12</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand Blvd Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
