<?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>IRCT20230612058460N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-21</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>the sustainable effect of self-care educational intervention on diet quality to reduce the risk of cardiovascular diseases in chronic patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the sustainable effect of self-care educational intervention on diet quality to reduce the risk of cardiovascular diseases in chronic patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>230</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Among the 4 comprehensive urban health service centers in Saravan, 2 centers will be selected as intervention centers and 2 centers will be selected as controls. Then 57 people from each center will be randomly selected from the list of chronic blood pressure patients (19 people), diabetes (19 people) and obesity (19 people) and will be included in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Self-care educational intervention - Diet quality - Cardiovascular diseases.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, the educational content will be prepared based on the guidelines of the Ministry of Health, articles and authentic books and educational booklets. The subjects of the educational sessions will include the recognition of chronic diseases, the importance of diet and self-care in preventing chronic diseases, adherence and following dietary guidelines, developing a low-salt diet, limiting alcohol consumption, maintaining a low-fat diet. In this research, visual educational materials including videos, photos, and illustrated pamphlets will be used, as well as interactive exercises where participants can share their experiences and learn how to act by observing others. The face validity of the educational materials will be determined in a review by a panel of ten experts consisting of doctors, nutritionists, nurses, health educators and patients. Training sessions will be held by health experts in comprehensive health service centers. The time of each session is approximately between 50 and 60 minutes, and each time groups of up to 10 people will participate in it. At the beginning of the study, control group patients will receive four training sessions on four consecutive days. Then, a one-hour training session will be held every 3 months until the end of the study in order to follow up and strengthen nutritional self-care behaviors, which will be a total of six training sessions during the project period. Intervention 2: Control group:  no intervention is done in 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The results of the study will be published in general</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossien Izadirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Hasabi Square - Zahedan University of Medical Sciences campus</address>
        <city>ZAHEDAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3372 5403</telephone>
        <email>izadi111389@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossien Izadirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Hasabi Square - Zahedan University of Medical Sciences campus</address>
        <city>ZAHEDAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3372 5403</telephone>
        <email>izadi111389@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People must be 18 years old or older.
Participants should be able to read and write.
Participants must be residents of Saravan city.
People in comprehensive health service centers should have health records.
Participants should not have cardiovascular diseases.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with mental and psychological problems
People with less than 6 months of residence in Saravan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z60.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other problems related to social environment</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, the educational content will be prepared based on the guidelines of the Ministry of Health, articles and authentic books and educational booklets. The subjects of the educational sessions will include the recognition of chronic diseases, the importance of diet and self-care in preventing chronic diseases, adherence and following dietary guidelines, developing a low-salt diet, limiting alcohol consumption, maintaining a low-fat diet. In this research, visual educational materials including videos, photos, and illustrated pamphlets will be used, as well as interactive exercises where participants can share their experiences and learn how to act by observing others. The face validity of the educational materials will be determined in a review by a panel of ten experts consisting of doctors, nutritionists, nurses, health educators and patients. Training sessions will be held by health experts in comprehensive health service centers. The time of each session is approximately between 50 and 60 minutes, and each time groups of up to 10 people will participate in it. At the beginning of the study, control group patients will receive four training sessions on four consecutive days. Then, a one-hour training session will be held every 3 months until the end of the study in order to follow up and strengthen nutritional self-care behaviors, which will be a total of six training sessions during the project period</i_keyword>
      <i_keyword>Control group:  no intervention is done in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diet quality. Timepoint: 6 months. Method of measurement: Assessment tool of healthy Eating Index-2015.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-27</approval_date>
        <contact_name>Ethics committee of zahedan University of Medical Sciences</contact_name>
        <contact_address>Imam Bakhsh St. 5- School of Nursing ZAHEDAN Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
