<?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>IRCT20190528043742N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-17</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Nursing Counseling on knowledge and Practice  Dietary Compliance in Patients with Celiac Disease</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Nursing Counseling on knowledge and Practice  Dietary Compliance in Patients with Celiac Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39920</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Throw Coin (Tap and Line)
Individual
Non-Transparent, Sealed Envelopes
Randomize Sequence Hiding, Blinding description: In this study, the outcome assessor  was kept blind to randomized appropriation, either parallel or single-blind design.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Celiac disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 49 patients were interviewed by nursing counseling method in the form of seven, verbally and face-to-face groups in the Celiac Center. Two weeks after the intervention sessions, a supplementary counseling session was organized to assess possible dietary problems Became Then one week after the supplementary counseling session, the questionnaires were filled out by knowledge and practice by telephone and in person by him and supervised by a research colleague who did not know the type of study group. Intervention 2: Control group :(50 patients) were studied based on routine care of the association.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only the Original outcome Can be Shared. The Main Consequence of my Study is Adherence  of Gluten-free diet in two Groups of Test and Control, and Only the Difference Outcome is Reported in the two Groups.

When:
The article in the journal is available within 1 month.

To whom:
Only Available Working Scholars in َAcademic Institutions

Conditions:
Due to the fact that ownership of the data with the Association, Celiac Special Clinic and Islamic Azad University of Isfahan (Khorasgan) is not possible to transfer data to other research groups.

Where to obtain:
Poursina Hakim Gastrointestinal Diseases Research Center, Poursina Hakim Clinic,Third Floor,Phase I, Health Center,  Sepehr Blvd, AghaBabaee Road, Isfahan.

How to obtain:
Step 1: Visit the site of the Iranian Celiac Association or Poursina Hakim Research Center or by visiting the relevant research expert.
 Step Two: Contract Collaboration
Step 3: Operate the data under the supervision of these centers

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahere karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Isfahan Branch (Khorasgan), University Blvd., Arghavaniyeh, East Jey St.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81551-39998</zip>
        <telephone>+98 31353540019</telephone>
        <email>karimitahere63@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Ziaeirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Isfahan Branch (Khorasgan), University Blvd., Arghavaniyeh, East Jey St.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81551-39998</zip>
        <telephone>+98 31353540019</telephone>
        <email>mziaeirad@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The Desire to Participate in the Study
Individuals Diagnosed with Celiac Disease by Gastroenterologist and Confirmed by Biopsy and Blood  Positive Serology  Test
People Who have been Gluten-Free Diet for more than 6 Months
People Over 18 Years of Age</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disinclination to Continue to Participate in Research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K55-K63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>A chronic Intestinal discomfort associated with malabsorption due to gluten intolerance.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 49 patients were interviewed by nursing counseling method in the form of seven, verbally and face-to-face groups in the Celiac Center. Two weeks after the intervention sessions, a supplementary counseling session was organized to assess possible dietary problems Became Then one week after the supplementary counseling session, the questionnaires were filled out by knowledge and practice by telephone and in person by him and supervised by a research colleague who did not know the type of study group.</i_keyword>
      <i_keyword>Control group :(50 patients) were studied based on routine care of the association.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of knowledge  in Dietary Compliance in  Patients with Celiac  Disease. Timepoint: Before starting the study and 5, 8, 10 weeks after the nursing consultation. Method of measurement: Dietary Compliance about knowledge Questionnaire (Researcher).</prim_outcome>
      <prim_outcome>Level of Practice  in Dietary Compliance in  Patients with Celiac  Disease. Timepoint: Before starting the study and 5, 8, 10 weeks after the nursing consultation. Method of measurement: Dietary Compliance about Practice Questionnaire (Researcher).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-22</approval_date>
        <contact_name>Ethics Committee of Isfahan Islamic Azad University (Khorasgan)</contact_name>
        <contact_address>Islamic Azad University, Isfahan Branch (Khorasgan), University Blvd, Arghavaniyeh, East Jey St. Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
