<?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>IRCT20210609051528N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-05</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of Education On Behavior And Nutritional Indicators Of Patients With Myocardial Infarction</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of Education Based On Health Belief Model On Behavior And Nutritional Indicators Of Patients With Myocardial Infarction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56852</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Persons will be divided into two groups of intervention and control based on a simple randomization method using a random number table. In this method, we put a set of numbers in the table without a specific pattern and order and completely randomly. To use a table of random numbers, we first specify the table numbers to read (for example, up, down, left, or right), then assume specific numbers for each group: We consider even numbers for the intervention group and odd numbers for the control group. Then we touch one of the numbers and move in one of the predetermined directions and record the numbers and assign them to the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with myocardial infarction in the intervention group, nutrition training intervention based on the structures of the Health Belief Model by holding 4 sessions of 60 minutes (Within a month, one session per week) using the methods Lectures, questions and answers, and slide shows will be held, and patients will be followed up by telephone during this time. The educational content has been prepared by the research team and it has been tried to make all the contents simple and understandable for all patients. The nutritional educational content is adjusted based on the economic situation of the people and includes: correcting the type and amount of oil consumed, correct cooking method and not using frying Increase consumption of vegetables and fruits to at least 5 units per day, replace low-fat dairy products with high-fat ones, reduce salt consumption, remove salt shakers from the table and avoid salty foods, eat lean meats, separate chicken skin before cooking, replace Vegetable protein instead of animal, eat fish 1 to 2 times a week, eat oily nuts 5 times a week, do not eat sweets and fatty foods. To measure the effect of the intervention, one and three months after the end of the training program, the data will be collected again. Also, three months after the intervention, blood sugar, total cholesterol, HDL, LDL, BMI will be measured. Intervention 2: Control group: The control group did not receive any educational intervention and used only the routine training of the rehabilitation center. It should be noted that at the end of the study, in order to observe ethics in research, all trainings will be provided to the control group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Shahnazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan, Hezar Jerib St., Isfahan University of Medical Sciences, Faculty of Health</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 3243</telephone>
        <email>h_shahnazi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Shahnazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health, Isfahan University of Medical Sciences, Hazar Jerib St, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 3243</telephone>
        <email>h_shahnazi@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>literacy
ability to communicate
having myocardial infarction
complete health of sight and hearing
lack of a special diet</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of severe disease conditions that prevent the patient from participating in education and learning
participation in educational programs similar to the present study
cancellation of cooperation
non-participation in at least two training sessions
the existence of underlying disease that interferes with the counseling program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with myocardial infarction in the intervention group, nutrition training intervention based on the structures of the Health Belief Model by holding 4 sessions of 60 minutes (Within a month, one session per week) using the methods Lectures, questions and answers, and slide shows will be held, and patients will be followed up by telephone during this time. The educational content has been prepared by the research team and it has been tried to make all the contents simple and understandable for all patients. The nutritional educational content is adjusted based on the economic situation of the people and includes: correcting the type and amount of oil consumed, correct cooking method and not using frying Increase consumption of vegetables and fruits to at least 5 units per day, replace low-fat dairy products with high-fat ones, reduce salt consumption, remove salt shakers from the table and avoid salty foods, eat lean meats, separate chicken skin before cooking, replace Vegetable protein instead of animal, eat fish 1 to 2 times a week, eat oily nuts 5 times a week, do not eat sweets and fatty foods. To measure the effect of the intervention, one and three months after the end of the training program, the data will be collected again. Also, three months after the intervention, blood sugar, total cholesterol, HDL, LDL, BMI will be measured.</i_keyword>
      <i_keyword>Control group: The control group did not receive any educational intervention and used only the routine training of the rehabilitation center. It should be noted that at the end of the study, in order to observe ethics in research, all trainings will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total cholesterol. Timepoint: before and three month after the start of the study. Method of measurement: measurement through experiments.</prim_outcome>
      <prim_outcome>HDL. Timepoint: before and three month after the start of the study. Method of measurement: measurement through experiments.</prim_outcome>
      <prim_outcome>LDL. Timepoint: before and three month after the start of the study. Method of measurement: measurement through experiments.</prim_outcome>
      <prim_outcome>FBS. Timepoint: before and three month after the start of the study. Method of measurement: measurement through experiments.</prim_outcome>
      <prim_outcome>BMI. Timepoint: before and three month after the start of the study. Method of measurement: weight/〖hight〗^2.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-09</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Health, Isfahan University of Medical Sciences, Hazar Jerib St, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
