<?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>IRCT20200507047343N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-28</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Self-Management Interventions Based on Group Cognitive Behavioral Treatment on Life Style, Quality of Life and Metabolic Syndrome Indexes in Adults with Metabolic Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Life Style Self-Management Interventions Based on Group Cognitive Behavioral Treatment on Life Style, Quality of Life and Metabolic Syndrome Indexes in Adults 30 years and older with Metabolic Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47977</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method will initially be connivance that first of all adults aged 30 years and older who refer to the comprehensive health service centers of Gonabad city who have the criteria to enter the study based on Specifications Registered in the Integrated Health System First, using the easy sampling method from three comprehensive health service centers in Gonabad, out of 290 adult clients with active care records, 88 people who are eligible to study are selected. Random allocation of the research sample will be done to two intervention and control groups based on quadruple block blocks, so that in each block of 4, two allocations will be allocated to the intervention group and two allocations to the control group. Different ones are created and each block is numbered with one number. The 4 blocks are selected based on a random number table until the sample size reaches 88. In the end, 44 people will be in the control group and 44 people will be in the intervention group, Blinding description: Participants themselves did not know the type of educational intervention, and the data analyst did not know the group due to the data encoding.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Metabolic Syndrome. Condition 2: Hypertension. Condition 3: obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In this study, lifestyle modification training based on the guidelines of therapeutic strategies in metabolic syndrome: lifestyle interventions to reduce metabolic syndrome and heart disease at Oxford University  will be performed in 8 sessions for the Intervention group. In line with the objectives of the study, the self-management intervention training program for lifestyle modification based on group cognitive-behavioral therapy for one month for 8 sessions  90  minutes as two sessions per week as follows for adults 30 years and older with intervention group metabolic syndrome Will be provided. Intervention 2: Control group: Control group: In the control group, routine care and individual training including booklet, pamphlet and face-to-face training will be provided in connection with the self care of metabolic syndrome and a general magic session.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
General information and data analysis

When:
At any time

To whom:
University researchers

Conditions:
General data analysis

Where to obtain:
Gonabad University of Medical Sciences

How to obtain:
Written request from

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Delshad Noghabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, Imam Khomeini 2</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691977458</zip>
        <telephone>+98 51 5722 7611</telephone>
        <email>delshad@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse Ave</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 7025</telephone>
        <email>ereza62@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 70-30 years
with metabolic syndrome, based on the criteria set out in the operational definition of metabolic syndrome,
not suffering from a known mental disorder such as depression and dementia
at least literate
have the necessary ability to take care of themselves
be prepared and satisfied to participate in the training course</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of willingness to continue working together
Absence in more than two sessions of training sessions
Need to change the medical treatment plan
He should be hospitalized during the research
Die during research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
      <hc_code>I10</hc_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic syndrome</hc_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In this study, lifestyle modification training based on the guidelines of therapeutic strategies in metabolic syndrome: lifestyle interventions to reduce metabolic syndrome and heart disease at Oxford University  will be performed in 8 sessions for the Intervention group. In line with the objectives of the study, the self-management intervention training program for lifestyle modification based on group cognitive-behavioral therapy for one month for 8 sessions  90  minutes as two sessions per week as follows for adults 30 years and older with intervention group metabolic syndrome Will be provided.</i_keyword>
      <i_keyword>Control group: Control group: In the control group, routine care and individual training including booklet, pamphlet and face-to-face training will be provided in connection with the self care of metabolic syndrome and a general magic session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle refers to the score a person receives from the Walker Lifestyle Questionnaire. Timepoint: At the beginning of the study, three months after the end of the intervention. Method of measurement: Health-Promoting Lifestyle questionnaire.</prim_outcome>
      <prim_outcome>Quality of life in this study refers to the score obtained before and three months after the intervention with the WHO Quality of Life Questionnaire (WHOQOL-BREF). Timepoint: At the beginning of the study, three months after the end of the intervention. Method of measurement: WHO Quality of Life Questionnaire (WHOQOL-BREF).</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-27</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Nurse Street Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
