<?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>IRCT2016081811763N29</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-27</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of nutrition education on patients undergoing hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Design and evaluation of nutrition education program based on health belief model (HBM) and its effect on the promotion of nutritional intake, quality of life and some nutritional and clinical outcomes in patients undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11938</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: For intervention group nutrition education appropriate to patients treated with hemodialysis, based on the latest scientific literature on such Krause's food &amp; nutrition therapy, Modern nutrition in health and disease and Nutritional education National kidney foundation, 8 sessions in 4 weeks (each session an hour, individual training and in groups of 5-6 people, using educational pamphlets and manuals). Intervention 2: The control group receive only the traditional training center offered.</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>Narjes Nooriani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>narjes.nooriani@gmail.com</email>
        <affiliation>Isfahan University of Medical Sciences-Nutrition College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Gholamreza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hezarjerib street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3668 8487</telephone>
        <email>ASKARI@MUI.AC.IR</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: chronic kidney disease; hemodialysis for at least 6 months; age range 60-20 years; having stable conditions; lack of malignancies; absence on the waiting list for a kidney transplant in the next 6 months; the ability to collaborate on a single project and participate in meetings and training group; no pregnancy and breastfeeding.&#13;
 Exclusion criteria: lack of desire to continue cooperation; the displacement of dialysis centers to other centers for any reason; history of acute diseases and malignancies; the need to link the project for any reason.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For intervention group nutrition education appropriate to patients treated with hemodialysis, based on the latest scientific literature on such Krause's food &amp; nutrition therapy, Modern nutrition in health and disease and Nutritional education National kidney foundation, 8 sessions in 4 weeks (each session an hour, individual training and in groups of 5-6 people, using educational pamphlets and manuals)</i_keyword>
      <i_keyword>The control group receive only the traditional training center offered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before, after and 3 months after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Nutritional intake. Timepoint: Before, after and 3 months after intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nutrient intake. Timepoint: Before, after and three months after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before, after and three months after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before, after and three months after intervention. Method of measurement: Using the formula weight (kg) / height (m) 2.</sec_outcome>
      <sec_outcome>CRP. Timepoint: Before, after and three months after intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>FBS. Timepoint: Before, after and three months after intervention. Method of measurement: The enzyme glucose oxidase method.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: Before, after and three months after intervention. Method of measurement: Jaffe method.</sec_outcome>
      <sec_outcome>BUN. Timepoint: Before, after and three months after intervention. Method of measurement: Chemical diacetyl Mvnvaksym.</sec_outcome>
      <sec_outcome>Serum sodium. Timepoint: Before, after and three months after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Serum potassium. Timepoint: Before, after and three months after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Serum calcium. Timepoint: Before, after and three months after intervention. Method of measurement: Colorimetric.</sec_outcome>
      <sec_outcome>Serum phosphorus. Timepoint: Before, after and three months after intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Hemoglobin. Timepoint: Before, after and three months after intervention. Method of measurement: Photometry.</sec_outcome>
      <sec_outcome>Hematocrit. Timepoint: Before, after and three months after intervention. Method of measurement: Calculated (HCT = RBC x MCV).</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before, after and three months after intervention. Method of measurement: Mercury manometers.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before, after and three months after intervention. Method of measurement: Mercury manometers.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-02</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezarjarib Street Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
