<?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>IRCT20150529022466N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-14</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Study of Islamic lifestyle education in pre-diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Islamic lifestyle based model education on quality of life, lifestyle and blood glucose control indices in pre-diabetic patients in Lamerd city, 2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization
Use the random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pre-diabetes.</hc_freetext>
      <i_freetext>Intervention 1: The intervention of this study is based on the curriculum provided by the researcher. The  designed education is based on the Islamic lifestyle tree (individual scale), Dr. Kaviani (2009), in three areas: personal, family and social. The contents of the training are verified by a religious and scientific expert. Training in four sessions of an hour and a half during two weeks for an intervention group divided into two groups of 19 will be presented by a researcher in the presence of a religious expert in a lecture and by PowerPoint at the educational hall of the Vali Asr Hospital. In order to remind the materials presented at the end of the sessions, they will be followed up the next week by telephone, so that during these two weeks people will be contacted twice about the implementation of Islamic lifestyle education (nutrition, physical activity, physical activity And .....) Questions will be asked. If less than 70% of the lessons learned after the second call are taught, they will be excluded from the study. We will answer them if they have a question. Intervention 2: Control group: At the end of the study, a pre-diabetes control brochure will be delivered 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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Shahnaz Pooladi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zabzabad Avu, University of Medical Sciences</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>pouladi2008@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>دکتر شهناز پولادی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>pouladi2008@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>✓ Fasting blood sugar between 125-100 mg / dL or hemoglobin glycolysis between 5/7 -6/4 percent
Do not use drugs that increase or decrease blood glucose
Non-chronic diseases of hemolytic anemia (sickle cell anemia, thalassemia
No pregnancy history in women participating in the study
No mental illness
Being Muslim</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Positive pregnancy test for women participating in the study during the study.
Incomplete filling in the questionnaire
Lack of regular attendance at training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention of this study is based on the curriculum provided by the researcher. The  designed education is based on the Islamic lifestyle tree (individual scale), Dr. Kaviani (2009), in three areas: personal, family and social. The contents of the training are verified by a religious and scientific expert. Training in four sessions of an hour and a half during two weeks for an intervention group divided into two groups of 19 will be presented by a researcher in the presence of a religious expert in a lecture and by PowerPoint at the educational hall of the Vali Asr Hospital. In order to remind the materials presented at the end of the sessions, they will be followed up the next week by telephone, so that during these two weeks people will be contacted twice about the implementation of Islamic lifestyle education (nutrition, physical activity, physical activity And .....) Questions will be asked. If less than 70% of the lessons learned after the second call are taught, they will be excluded from the study. We will answer them if they have a question.</i_keyword>
      <i_keyword>Control group: At the end of the study, a pre-diabetes control brochure will be delivered to the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Glycosylated hemoglobin. Timepoint: Before the intervention and three months after the initial measurement. Method of measurement: Device and Kite Srastat - Manually,.</prim_outcome>
      <prim_outcome>Fasting blood suga. Timepoint: Before the intervention and three months after the initial measurement. Method of measurement: deviceDeroi autoanalyzer by calorimetric enzyme method.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention and repeat one and three months after the intervention. Method of measurement: World Health Organization Quality of Life questionnaire 26 questions (quality of life).</prim_outcome>
      <prim_outcome>Life style. Timepoint: Before the intervention and repeat one and three months after the intervention. Method of measurement: Lifestyle  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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-18</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>School of nursing and midwifery; Bushehr University of medical sciences; Rishehr avenue; Sabzabad avenue; Bushehr Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
