<?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>IRCT20210808052115N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-06</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of healthy lifestyle education through peer  education and virtual education (based on Interactive virtual classroom and applications) on indicators of lifestyle that promotes health, self-esteem and self-efficacy of diabetics</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of healthy lifestyle education through peer  education and virtual education (based on Interactive virtual classroom and applications) on indicators of lifestyle that promotes health, self-esteem and self-efficacy of diabetics referred to military hospitals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57979</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The allocation clause will be used. To randomly assign patients to three groups of peer education, virtual education and control, the six-random block method is used as follows. Groups will be assigned letters A, B and C randomly (BCACAB, BACCAB, ABCBAC, CBAACB blocks). In this method, blocking is based on the week and possible blocks are selected randomly. For example, patients who visit the Armed Forces Hospital in the endocrine ward in the first week enter control group B. Patients in the second week are in the peer education group C in the third week are in the virtual education group A, and so on blockchain is continued until so many blocks are selected It is possible to obtain the required sample size.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Peer Education Intervention group: In the present study, the purpose of peer education is to provide face-to-face training through trained peers by holding classes, lectures and questions and answers for 4 sessions of 35 minutes. Intervention 2: Virtual education intervention group (based on interactive virtual classroom and application): A virtual education program designed by the researcher that includes how to take care of themselves such as diet and activity, etc. The researcher implemented a training program The training program includes a clip , Image, audio, text and application are provided to patients in three sessions every other day for two months in a virtual training group. Intervention 3: Control group: without any intervention by researchers.</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 It is not yet known if there will be a plan to make this available.The satisfaction of participation's in this study has not been measured yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azad Fatahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>safiabad village</address>
        <city>javanrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6797168353</zip>
        <telephone>+98 83 4629 5184</telephone>
        <email>azad8271@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azad Fatahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>safiabad village</address>
        <city>javanrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6797168353</zip>
        <telephone>+98 83 4629 5184</telephone>
        <email>azad8271@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least six months have passed since the diagnosis of uncontrolled type 2 diabetes based on the fasting blood sugar index above 126 mg / dL.
Have an age range between 21 and 75 years
Have no history of participating in diabetes education programs during the past six months.
Willingness to participate in the present study.
Be literate and use a smartphone.
Be able to speak Persian.
Mobile access and the ability to use it
Ability to install software on mobile phones and Internet access
Do not have cognitive problems, physical disabilities, need for diabetic foot surgery, 
No medical or related education
Absence of hearing or vision impairment
Not be a part of treatment staff
Possibility to make direct telephone calls to the patient and his active family member.</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient develops new physical problems that make them lose the ability to take care of themselves.
Reluctance to cooperate the study
Do not use software</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus without complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Peer Education Intervention group: In the present study, the purpose of peer education is to provide face-to-face training through trained peers by holding classes, lectures and questions and answers for 4 sessions of 35 minutes.</i_keyword>
      <i_keyword>Virtual education intervention group (based on interactive virtual classroom and application): A virtual education program designed by the researcher that includes how to take care of themselves such as diet and activity, etc. The researcher implemented a training program The training program includes a clip , Image, audio, text and application are provided to patients in three sessions every other day for two months in a virtual training group.</i_keyword>
      <i_keyword>Control group: without any intervention by researchers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health Promoting Lifestyle Indicators. Timepoint: Before the intervention and two months later, patients in all three groups are assessed using a questionnaire promoting health. Method of measurement: Walker Health Promoting Lifestyle Questionnaire (HPLPII).</prim_outcome>
      <prim_outcome>Self-Esteem. Timepoint: Before the intervention and two months later, patients in all three groups are assessed using a questionnaire self-esteem. Method of measurement: Rosenberg Self-Esteem Questionnaire.</prim_outcome>
      <prim_outcome>Self-Efficacy. Timepoint: Before the intervention and two months later, patients in all three groups are assessed using a self-efficacy of diabetic patients questionnaire  . Method of measurement: Type 2 Diabetic Self-Efficacy Questionnaire (DMSES).</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-08</approval_date>
        <contact_name>AJA University of Medical Sciences</contact_name>
        <contact_address>Tehran, Ghods Town (West), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
