<?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>IRCT2016121824340N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-25</date_registration>
      <primary_sponsor>Vice Chancellor for research of Urmia University of Medical Sciences</primary_sponsor>
      <public_title>The impact of counseling on dietary behaviors among anemic pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The   effect  of  intervention  based  on  health  belief  model on dietary behavior promotion among pregnant  women  with  iron  deficiency  anemia  attending to health center</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20573</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: After selecting the people of each center based on the criteria of entry and exit , randomly using a packet in a blind and blind envelope, the control group will be 30 and the intervention group will be 30 people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After completing a researcher-made questionnaire based on the Health Belief Model by the intervention group on anemia and nutrition during pregnancy, the educational and counseling sessions for the intervention group were held through 4 sessions of 60-90 minutes (one session every week) and these educational contents were given to the patients via lecture, Group discussion, question and answer as well as individual nutrition counseling according to the health belief model  and according to the country's guidelines. Intervention 2: Control group: After completing a researcher-made questionnaire based on the health belief model, the control group did not undergo any educational interventions on anemia and nutrition during pregnancy. The control group received only routine health care from their care providers.</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>Hamideh Mohaddesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery Faculty Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3327 5496</telephone>
        <email>hmohaddesi.han@gmail.com</email>
        <affiliation>Urmia University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamideh Mohaddesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University Of Medical Science, Nursing and Midwifery Faculty  Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44332754963</telephone>
        <email>hmohaddesi.han@gmail.com</email>
        <affiliation>Urmia 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>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : aged between 35-18 years; no specific underlying disease :chronic renal failure and infection of HI, parasitic infections, malaria, schistosomiasis and hookworm infections; iron deficiency anemia :Hemoglobin less than 11 mg per deciliter and willingness to enter the study; ability to read and write; experiencing last pregnancy less than last three years.&#13;
&#13;
 Exclusion criteria: Pre-eclampsia and eclampsia; gestational diabetes; preterm delivery; hyperemesis gravidarom; high and low BMI below 18.5 and over 25.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Nutritiona</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>D50.9 Iron deficiency anaemia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After completing a researcher-made questionnaire based on the Health Belief Model by the intervention group on anemia and nutrition during pregnancy, the educational and counseling sessions for the intervention group were held through 4 sessions of 60-90 minutes (one session every week) and these educational contents were given to the patients via lecture, Group discussion, question and answer as well as individual nutrition counseling according to the health belief model  and according to the country's guidelines.</i_keyword>
      <i_keyword>Control group: After completing a researcher-made questionnaire based on the health belief model, the control group did not undergo any educational interventions on anemia and nutrition during pregnancy. The control group received only routine health care from their care providers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dietary behavior. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
      <prim_outcome>Knowledge. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
      <prim_outcome>Perceived susceptibility. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
      <prim_outcome>Perceived severity. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
      <prim_outcome>Perceived benefits. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
      <prim_outcome>Perceived barriers. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
      <prim_outcome>Cues  to action. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
      <prim_outcome>Self efficacy. Timepoint: Pretest (Before intervention) and post test (Two months after intervention). Method of measurement: Questionnaire created based on Health Belief Model.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemoglobin. Timepoint: One month after  iron therapy and 26th-30th week of pregnancy. Method of measurement: Health records.</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 of Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-19</approval_date>
        <contact_name>Ethics committee of  Urmia University of Medical Sciences</contact_name>
        <contact_address>(postal code:571478334), Urmia University of Medical Sciences, Orghance Street, Resalat blvd, Urmia Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
