<?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>IRCT201105183706N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-31</date_registration>
      <primary_sponsor>Vice chancellor for research,Tabriz University of Medical Science</primary_sponsor>
      <public_title>Effect of an educational package on nutritional knowledge, beliefs and behaviors  in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of educational package on nutritional knowledge, beliefs and behaviors in  pregnant women :A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-07-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3801</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nutrition during pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: implementation of a nutritional education package, i.e. at first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife, will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects can also get telephone counseling about nutrition. Intervention 2: Control group: implementation of a sex education package, i.e. at first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife with special short education in sexual health in pregnancy, will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects and their husbands  can also get telephone counseling about sexual health.</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>Fatemeh Omidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South shariati</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>44931-83648</zip>
        <telephone>+98 14 2762 1281</telephone>
        <email>fatemeomidi45@yahoo.com; omidi_f90@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Mohammad-Alizadeh-charandabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, South Shariati</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 2699</telephone>
        <email>alizades@tbzmed.ac.ir</email>
        <affiliation>Faculty of Nursing And Midwifery, Tabriz University of Medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: pregnant women in 8-14 weeks of pregnancy; having health records in Karaj city health centers; willing to stay in Karaj, Iran during pregnancy; no history of known chronic disorders such as: cardiovascular, renal, respiratory, gastrointestinal, blood, autoimmune, diabetes, lupus, thyroid, epilepsy, chronic hypertension, cancer; no history of bleeding and threatened abortion, multiple pregnancy, PROM and preterm delivery, severe nausea and vomiting in pregnancy, intrauterine growth retardation, preclampsia, gestational diabetes and  infertility; not being smoker, alcohol and drug user and  having six years or more school education &#13;
Exclusion criteria: termination of pregnancy for any reason within 6 weeks after the second educational session.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supervision of normal pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: implementation of a nutritional education package, i.e. at first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife, will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects can also get telephone counseling about nutrition.</i_keyword>
      <i_keyword>Control group: implementation of a sex education package, i.e. at first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife with special short education in sexual health in pregnancy, will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects and their husbands  can also get telephone counseling about sexual health.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge, bliefs and behaviors of nutrition on  pregnant women. Timepoint: Before intervention, one month after intervention,in 24-28 weeks of pregnancy,in 36-40 weeks of pregnancy. Method of measurement: Through self-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight gain of mother. Timepoint: Before intervention, one month after intervention,in 24-28 weeks of pregnancy,in 36-40 weeks of pregnancy. Method of measurement: Recorded weight gain in the health record.</sec_outcome>
      <sec_outcome>Child birth weight. Timepoint: Within the 12 hours after birth. Method of measurement: Weight recorded in the summary birth record.</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 Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-05-26</approval_date>
        <contact_name>Research deputy, Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
