<?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>IRCT2014022316701N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-03-31</date_registration>
      <primary_sponsor>Hamadan University of Medical Sciences - Vice chanellor for Research and Technology</primary_sponsor>
      <public_title>The effect of education on prenatal supplements</public_title>
      <acronym></acronym>
      <scientific_title>Survey effect of educational program by BASNEF model on nutritional supplements use during pregnancy among pregnant women referred to health centers in Hamadan city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15549</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>Condition 1: nutritional supplements use during pregnancy. Condition 2: nutritional supplements use during pregnancy. Condition 3: nutritional supplements use during pregnancy. Condition 4: nutritional supplements use during pregnancy. Condition 5: nutritional supplements use during pregnancy. Condition 6: nutritional supplements use during pregnancy. Condition 7: nutritional supplements use during pregnancy. Condition 8: nutritional supplements use during pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: A training manual utilizes the scientific literature by the researcher will be provided after confirmation of its validity and reliability will be held in 4 sessions (one session per week) and about 60 minutes for each session for  the third  month pregnant women in the intervention group. Teaching methods will include lectures, group discussions and questions and answers. Intervention 2: For the control group, there will be no educational intervention.</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>Tahere etesamifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan - opposite of Mardom Park - Hamadan University of Medical Sciences</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1838 0574</telephone>
        <email>ICT@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahere Etesamifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan - opposite of Mardom Park - Hamadan University of Medical Sciences</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1838 0574</telephone>
        <email>ICT@umsha.ac.ir</email>
        <affiliation>Hamadan 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: Third trimester pregnant women referred to health centers in north of Hamadan;  Written informed consent by the pregnant women under study; Lack of a ban on pregnancy supplements use.Exclusion criteria: Pregnant women who do not wish to continue participating in the study; Ban the use of one or all three supplements during pregnancy, in terms of doctor or midwife; Termination of pregnancy during the study for any reason (including abortion, and the doctor's advice, ...); Change the location so that they will be removed from the covered  population; Refusing to participate in workshop two sessions and more.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E50</hc_code>
      <hc_code>E51</hc_code>
      <hc_code>E53</hc_code>
      <hc_code>E54</hc_code>
      <hc_code>E55</hc_code>
      <hc_code>E56</hc_code>
      <hc_code>E58</hc_code>
      <hc_code>E61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vitamin A deficiency</hc_keyword>
      <hc_keyword>Thiamine deficiency</hc_keyword>
      <hc_keyword>Deficiency of other B group vitamins</hc_keyword>
      <hc_keyword>Ascorbic acid deficiency</hc_keyword>
      <hc_keyword>Vitamin D deficiency</hc_keyword>
      <hc_keyword>Other vitamin deficiencies</hc_keyword>
      <hc_keyword>Dietary calcium deficiency</hc_keyword>
      <hc_keyword>Deficiency of other nutrient elements</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A training manual utilizes the scientific literature by the researcher will be provided after confirmation of its validity and reliability will be held in 4 sessions (one session per week) and about 60 minutes for each session for  the third  month pregnant women in the intervention group. Teaching methods will include lectures, group discussions and questions and answers.</i_keyword>
      <i_keyword>For the control group, there will be no educational intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nutritional supplements use during pregnancy. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</sec_outcome>
      <sec_outcome>Belifes &amp; evaluational of behavioral outcome. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</sec_outcome>
      <sec_outcome>Attitude toward the behavior. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</sec_outcome>
      <sec_outcome>Normative beliefs. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</sec_outcome>
      <sec_outcome>Subjective norms. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</sec_outcome>
      <sec_outcome>Behavioral intention. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</sec_outcome>
      <sec_outcome>Enabling factors. Timepoint: Before the intervention, immediately after intervention, and two months after the end of intervention. Method of measurement: Made questionnaire.</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>Hamadan University of Medical Sciences - Vice chanellor for Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-04-08</approval_date>
        <contact_name>Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamadan - Fahmideh strett - opposit Mardom Park Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
