<?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>IRCT20211226053527N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-19</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Designing, implementing  and evaluating  of educational program based on a Multi-Theory Model regarding preventive behaviors of Covid-19 in students in Yazd city</public_title>
      <acronym></acronym>
      <scientific_title>Designing, implementing, and evaluating  of educational program based on a Multi-Theory Model regarding preventive behaviors of Covid-19 in students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61067</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Two-stage random cluster sampling method
First, all universities in Yazd will be selected as study clusters, then individuals will be randomly selected from each cluster and based on the last digit of the student number will be transferred to the intervention and control groups. Students whose last digit of the student number is even will be in the intervention group and students whose last digit of the student number is an individual will be in the control group.</study_design>
      <phase>2</phase>
      <hc_freetext>covid19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, an educational program based on a multi-theory model will be implemented for students. For the structure of participatory dialogue, group discussion sessions, for the structure of behavioral confidence in film screening, for the structure of physical environment change, adjustment of environmental access, for the structure of emotional transformation, motivational speech, for the structure of practice to change self-monitoring checklist and for the structure of social environment. University officials will be executed. Intervention 2: Control group: The educational program will not be implemented for the control group and only for the observance of ethical considerations, at the end of the study, an educational pamphlet will be distributed among the students of this 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data obtained from the study will be visible in the published articles of the dissertation.

When:
November 2022

To whom:
Readers of dissertation articles

Conditions:
The data in the articles can be used with the condition of referencing the article

Where to obtain:
Refer to articles

How to obtain:
Refer to articles

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Khaleghi Moori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Esteghlal Street</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917834585</zip>
        <telephone>+98 35 3721 5759</telephone>
        <email>mah.khaleghi.ph@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Khaleghi Moori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Esteghlal Street</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917834585</zip>
        <telephone>+98 35 3721 5759</telephone>
        <email>mah.khaleghi.ph@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Studying at Yazd University
having a smartphone
internet access
Having Whats App &amp; Telegram applications
undergraduate students</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>22 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, an educational program based on a multi-theory model will be implemented for students. For the structure of participatory dialogue, group discussion sessions, for the structure of behavioral confidence in film screening, for the structure of physical environment change, adjustment of environmental access, for the structure of emotional transformation, motivational speech, for the structure of practice to change self-monitoring checklist and for the structure of social environment. University officials will be executed.</i_keyword>
      <i_keyword>Control group: The educational program will not be implemented for the control group and only for the observance of ethical considerations, at the end of the study, an educational pamphlet will be distributed among the students of this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Initiation of behavior. Timepoint: Before the intervention and 30 days after the intervention. Method of measurement: With an online questionnaire.</prim_outcome>
      <prim_outcome>Maintain of behavior. Timepoint: Before the intervention and 30 days after the intervention. Method of measurement: With an online questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Participatory dialouge. Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: With an online questionnaire.</sec_outcome>
      <sec_outcome>Behavioral confidence. Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: With an online questionnaire.</sec_outcome>
      <sec_outcome>Change in physical environment. Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: With an online questionnaire.</sec_outcome>
      <sec_outcome>Emotional transformation. Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: With an online questionnaire.</sec_outcome>
      <sec_outcome>Practice for change. Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: With an online questionnaire.</sec_outcome>
      <sec_outcome>Change in social environment. Timepoint: Before the intervention and 1 month after the intervention. Method of measurement: With an online 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-15</approval_date>
        <contact_name>Research Ethics Committees of School of Public Health - Shahid Sadoughi University of Medical Scienc</contact_name>
        <contact_address>East Esteghlal Street Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
