<?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>IRCT2015080510324N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of training package on self-care behavior and quality of life in pregnant women with gestational diabetic.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of training package on self-care behavior and quality of life in pregnant women with gestational diabetic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10801</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>Gestational diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Interventional group: Individuals in the intervention group will receive education about self-care behaviors regarding diabetes. Education plan includes four educational sessions as group discussion about 60 minutes; held for groups of 7 to 14 persons for four consecutive weeks. At the end of the first session, a booklet will be given to intervention group.  The content of the training manual contains definition of diabetes, causes, complications, treatment and prevention of disease complications with an emphasis on physical activity and appropriate nutrition. Intervention 2: Control group: The individuals in the control group will receive routine educations of prenatal care.</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>Havin Zandi Nava</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, South Shariati Street  Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 87 3362 8972</telephone>
        <email>farnooshzandinava@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mojgan Mirghafourvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty, South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>347-51745</zip>
        <telephone>+98 41 1479 6770</telephone>
        <email>Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Pregnant women with gestational diabetes under supervision in the diabetic clinic of Tohid Hospital in Sanandaj; Diagnosis of gestational diabetes by OGTT between 24-28 weeks  of pregnancy; Singleton pregnancy ; Having at least secondary education; Self-care ability alone; Willingness to participate in the study; Possibility of going to hospital within 4 sequential weeks. &#13;
 Exclusion criteria: Having other physical diseases (asthma and heart disease) and known psychiatric disease according to patient’s expression.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus arising in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventional group: Individuals in the intervention group will receive education about self-care behaviors regarding diabetes. Education plan includes four educational sessions as group discussion about 60 minutes; held for groups of 7 to 14 persons for four consecutive weeks. At the end of the first session, a booklet will be given to intervention group.  The content of the training manual contains definition of diabetes, causes, complications, treatment and prevention of disease complications with an emphasis on physical activity and appropriate nutrition.</i_keyword>
      <i_keyword>Control group: The individuals in the control group will receive routine educations of prenatal care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care behavior. Timepoint: Before and four weeks after the end of intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and four weeks after the end of intervention. Method of measurement: Quality of life (QOL-GRAV) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gestational age at the delivery. Timepoint: After childbirth. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Delivery type. Timepoint: After childbirth. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Anthropometric indices of newborn. Timepoint: After childbirth. Method of measurement: Checklist.</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, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan  Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
