<?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>IRCT20230521058243N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-31</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of education on self-care in women with type 2 diabetes</public_title>
      <acronym>SCT</acronym>
      <scientific_title>Investigating the effect of team-oriented educational intervention on promoting self-care in women with type 2 diabetes; A cluster randomized controlled trial using social-cognitive theory</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70256</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: To select the samples using a multi-stage cluster method, first, among the 12 comprehensive health service centers in Boushehr, all of which provide services in the diabetes prevention and control program to people with diabetes, 4 comprehensive health service centers were selected. A simple random method will be selected, then in this step, in order to prevent information leakage of these 4 centers, 2 centers were selected by a simple random method (lottery method) and assigned to the intervention groups and 2 centers to the control groups. They will be .In the next step, a list of people with diabetes who meet the criteria for entering the study will be prepared by using the information registered in the Integrated Health System (SIB). Then, with regular random method, the desired sample size will be selected from among them. After obtaining informed consent from the people, and having the entry criteria, then they complete the prepared questionnaires.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention group: Education about diabetes and the importance of self-care and its elements, familiarity with controlling and monitoring blood sugar and blood pressure, prevention of diabetes complications, healthy eating and physical activity, correct use of medicine, foot care and interaction with peer group, family, health care provider and doctor , in person to the intervention group, in 6 sessions of 60 to 80 minutes with the method of interactive lectures, group discussions and also using media such as: slide show in PowerPoint format, clip show, practical show and booklet in line with knowledge structures. Behavioral intention, outcome expectancy, perceived self-efficacy and perceived social support will be conducted.</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 Due to confidentiality of information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Salemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr, Moalem St., in front of Friday prayer, Bushehr University of Medical Sciences and Health Services</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>00987133322081-5</telephone>
        <email>azadehsalemi87@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hosein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Razi Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۵۵۴۱ - ۷۱۵۳۶</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>Mhkaveh255@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes based on the definitive diagnosis entered in the file
At least one year has passed since the definitive diagnosis of the disease
Ability to read, write and speak Farsi
Age between 30 and 59 years
Not having severe complications caused by diabetes, including eye disease, kidney disease, and leg/skin ulcers
Willingness to participate in the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The occurrence of a severe health condition that prevents the person from continuing to attend and participate in the course
Leaving the research environment for any reason (withdrawal, death and migration)
Absence of more than 2 sessions of the training program
Failure to participate in the pre-test and post-test•
Participation in the ongoing program similar to the present study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Education about diabetes and the importance of self-care and its elements, familiarity with controlling and monitoring blood sugar and blood pressure, prevention of diabetes complications, healthy eating and physical activity, correct use of medicine, foot care and interaction with peer group, family, health care provider and doctor , in person to the intervention group, in 6 sessions of 60 to 80 minutes with the method of interactive lectures, group discussions and also using media such as: slide show in PowerPoint format, clip show, practical show and booklet in line with knowledge structures. Behavioral intention, outcome expectancy, perceived self-efficacy and perceived social support will be conducted</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in the mean scores of knowledge related to diabetes. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Changes in the mean scores of diabetes self-care behavior intention. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Changes in the mean scores of participants' outcome expectations. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Changes in the mean scores of participants' perceived social support. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Changes in the mean scores of participants' perceived self-efficacy. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Changes in the average amount of glycosylated hemoglobin. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Changes in the average amount of fasting blood sugar. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Changes in the mean scores of participants' self-care behavior. Timepoint: before the intervention and 3 months after the intervention. Method of measurement: Questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-20</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz, Zand Street, Shiraz University of Medical Sciences Central Building, 7th Floor, Research and Technology Deputy Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
