<?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>IRCT20110727007132N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-02</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Development and evaluation of education intervention based on Extended Parallel Process Model in adopting preventive behaviors of Metabolic syndrome among employees</public_title>
      <acronym></acronym>
      <scientific_title>Development and evaluation of education intervention based on Extended Parallel Process Model in adopting preventive behaviors of Metabolic syndrome among employees</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61288</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: There is no special characteristic in this study, Randomization description: The administrative employee list of Rafsanjan University of Medical Sciences (with the exception of the faculty members) is available to researchers. We will select 144 people from this list at random and then randomly assign these individuals to the experimental and control groups. For randomization we will use block size 4. With a sample size of 144, 36 blocks of size 4 will be produced based on this online software: www.sealedenvelope.com.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: According to pre-test results, educational intervention in terms of metabolic syndrome will be developed and conducted for the study participants in the intervention group. Educational intervention based on the structures of the Extended Parallel Process Model in the form of a 4-hour online workshop in 8 sessions (general content of the sessions: Familiarity and study of risk factors of metabolic syndrome, identification of sensitivities and perception of conditions, education based on perception, familiarity with complications and sensitivities, assessing the individual's awareness to provide training, familiarity with changing behavior and healthy lifestyle, evaluating the knowledge and training given in these sessions, familiarizing the individual with the effects of metabolic syndrome, determining the effectiveness of training) and presenting a pamphlet (definition of the metabolic syndrome and its criteria and consequences - Lifestyle Modification Behaviors) will be designed to address lifestyle modification measures to prevent metabolic syndrome. This training will be done for people in the intervention group. Intervention 2: Control group: Control group: No intervention.</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 The results only will be published in the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Tahereh Dehdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran university of Medical Sciences, Shahid Hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 4756</telephone>
        <email>dehdarit@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Tahereh Dehdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran university of Medical Sciences, Shahid Hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 4756</telephone>
        <email>dehdarit@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Employing in the administrative departments of Rafsanjani University of Medical Sciences
Not having academic degree in health, paramedical and medical fields</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnancy
Breastfeeding
History of diagnosed metabolic syndrome
History of endocrine disorders and immunodeficiency
Substance abuse
Consumption of weight reduction medications
History of diagnosed atherosclerosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: According to pre-test results, educational intervention in terms of metabolic syndrome will be developed and conducted for the study participants in the intervention group. Educational intervention based on the structures of the Extended Parallel Process Model in the form of a 4-hour online workshop in 8 sessions (general content of the sessions: Familiarity and study of risk factors of metabolic syndrome, identification of sensitivities and perception of conditions, education based on perception, familiarity with complications and sensitivities, assessing the individual's awareness to provide training, familiarity with changing behavior and healthy lifestyle, evaluating the knowledge and training given in these sessions, familiarizing the individual with the effects of metabolic syndrome, determining the effectiveness of training) and presenting a pamphlet (definition of the metabolic syndrome and its criteria and consequences - Lifestyle Modification Behaviors) will be designed to address lifestyle modification measures to prevent metabolic syndrome. This training will be done for people in the intervention group.</i_keyword>
      <i_keyword>Control group: Control group: No intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increasing the behavior of study participants in terms of prevention of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Modifying the attitude of study participants in terms of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Increasing the perceived susceptibility of study participants in terms of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Increasing the perceived severity of study participants in terms of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Increasing the fear of study participants in terms of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Decreasing the defensive mechanisms of study participants in terms of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Increasing the perceived self-efficacy of study participants in terms of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Increasing the response efficacy of study participants in terms of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Increasing the intention of study participants in terms of prevention of metabolic syndrome. Timepoint: Before and six months after the intervention. Method of measurement: questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-01</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences and Health Services</contact_name>
        <contact_address>ran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
