<?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>IRCT2017050333803N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-26</date_registration>
      <primary_sponsor>Vice Chancellor for research, Iran University of Medical Science</primary_sponsor>
      <public_title>The Effect of education on metabolic syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of self-care program education on anthropometric  indicators in postmenopausal women with metabolic syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomized by colored bullets.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention will be based on a self-care education program. This program will be designed and implemented based on Orem's supportive-educative system; which will include a collection of self-care training programs that assist patients to identify and investigate their needs. This education package will include training the subjects to improve their understanding and awareness of metabolic syndrome and menopause, nutrient regimen, medication regimen,  physical activity, and weight loss.This program will be conducted in 5 sessions of 45 minutes duration, of which 30 minutes will include oral presentation and 15 minutes for questions and answers. The program will run over 5 weeks (one session per week), in groups of 5 to 7 people. The training, will start and end at a certain date and will be provided by 5 research assistants. These training programs will be conducted in the morning shift and in the selected healthcare centers of Tehran municipality. The training will contain providing  information to the participants regarding metabolic syndrome and its relationship to menopause, complications of the disease, dietary( use of fresh vegetables and fruit, low salt and carbohydrate diet, reduced consumption of saturated fatty acids and their importance and a variety of foods that can be used), medication regimen ( the importance of taking them on time, dosage and their effects ), weight loss and physical activity ( aerobic sports, type of physical activity and its role in health ). The training program will also include educating the participants on how to measure their blood pressure, weight and blood sugar levels. At the end of each session, the subjects will be given educational pamphlets of that.&#13;
The final educational material will be in the form of a booklet with 5 chapters, which will include: metabolic syndrome and menopause( chapter I ), diet and metabolic syndrome ( chapter II ), medication regimen and metabolic syndrome ( chapter III ), physical activity, weight loss and metabolic syndrome ( chapter IV ), and how to measure blood pressure, body weight and blood sugar ( chapter V ). The content of this booklet will be reviewed and approved   by 10 medical and surgical scholars. To evaluate the efficiency of training, the participants will be asked two questions at the beginning of each session about the previous session and how they incorporated that at home. It is worth noting that the trainers will be available to answer any questions raised by participants via phone,  if needed. At the end of this study the subjects will be rewarded for  their participation. Intervention 2: Control group: In this group there, will not be any intervention and they will continue to have their usual lifestyle as before. At the end of this investigation they will be provided with the educational material and also will be rewarded as their other counterparts for their participation in this program.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Daryadokht masror rodsari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi Street, Valiasr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1709</telephone>
        <email>Daryadokht_Masros@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Daryadokht Masror rodsari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Rashid Yasemi Street, Valiasr Street, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1709</telephone>
        <email>Daryadokht_Masror@yahoo.com</email>
        <affiliation>Iran 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>
      <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>Inclusion criteria:Postmenopausal women aged between 45 to 60 years old; Approval of developing metabolic syndrome by physician; Approved mental, emotional and cognitive health by self-reporting; The absence of cardiovascular disease, diabetes, cancer and hypothyroidism; Not being on hormone therapy.&#13;
Exclusion criteria: Perform a total hysterectomy and oophorectomy during study; Not attending the entire training sessions.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E70-E90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic disorderes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention will be based on a self-care education program. This program will be designed and implemented based on Orem's supportive-educative system; which will include a collection of self-care training programs that assist patients to identify and investigate their needs. This education package will include training the subjects to improve their understanding and awareness of metabolic syndrome and menopause, nutrient regimen, medication regimen,  physical activity, and weight loss.This program will be conducted in 5 sessions of 45 minutes duration, of which 30 minutes will include oral presentation and 15 minutes for questions and answers. The program will run over 5 weeks (one session per week), in groups of 5 to 7 people. The training, will start and end at a certain date and will be provided by 5 research assistants. These training programs will be conducted in the morning shift and in the selected healthcare centers of Tehran municipality. The training will contain providing  information to the participants regarding metabolic syndrome and its relationship to menopause, complications of the disease, dietary( use of fresh vegetables and fruit, low salt and carbohydrate diet, reduced consumption of saturated fatty acids and their importance and a variety of foods that can be used), medication regimen ( the importance of taking them on time, dosage and their effects ), weight loss and physical activity ( aerobic sports, type of physical activity and its role in health ). The training program will also include educating the participants on how to measure their blood pressure, weight and blood sugar levels. At the end of each session, the subjects will be given educational pamphlets of that.&#13;
The final educational material will be in the form of a booklet with 5 chapters, which will include: metabolic syndrome and menopause( chapter I ), diet and metabolic syndrome ( chapter II ), medication regimen and metabolic syndrome ( chapter III ), physical activity, weight loss and metabolic syndrome ( chapter IV ), and how to measure blood pressure, body weight and blood sugar ( chapter V ). The content of this booklet will be reviewed and approved   by 10 medical and surgical scholars. To evaluate the efficiency of training, the participants will be asked two questions at the beginning of each session about the previous session and how they incorporated that at home. It is worth noting that the trainers will be available to answer any questions raised by participants via phone,  if needed. At the end of this study the subjects will be rewarded for  their participation.</i_keyword>
      <i_keyword>Control group: In this group there, will not be any intervention and they will continue to have their usual lifestyle as before. At the end of this investigation they will be provided with the educational material and also will be rewarded as their other counterparts for their participation in this program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Using a digital scale Seca and with an accuracy of 0.1 kg.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Weight by the square of height in metric units.</prim_outcome>
      <prim_outcome>Waist circomference. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Using plastic meters and with an accuracy of 0.1 cm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Waist-to-hip ratio. Timepoint: Before and 8 weeks after the intervention. Method of measurement: By dividing the waist measurement by the hip measurement unit cm.</sec_outcome>
      <sec_outcome>Waist to Height Ratio. Timepoint: Before and 8 weeks after the intervention. Method of measurement: By dividing the waist measurement units cm in height per cm.</sec_outcome>
      <sec_outcome>The middle arm circomference. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Using plastic meters per cm.</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>Vice Chancellor for research, Iran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-25</approval_date>
        <contact_name>Ethics Commmittee of Iran University of Medical Science</contact_name>
        <contact_address>Iran University of Medical Science, Hemmat Highway, Tehran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
