<?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>IRCT20220221054086N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of educational interventions on prevention of oral cancer based on the behavior change model</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of educational interventions on preventive behaviors of oral cancer based on the Theory of Planned Behavior among people aged 15 years and more: A cluster randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>400</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62120</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: This study will be performed using simple cluster random sampling. Based on the socio-economic development index, the city of Tehran is divided into five areas of advantaged, relatively-advantaged, semi-advantaged, low-advantaged, and very low-advantaged. The city of Tehran has 22 districts, of which the advantaged area includes four districts (1, 2, 3, 6), the relatively-advantaged area includes two districts (5, 7), the semi-advantaged area includes six districts (4, 8, 11, 13, 21, 22), the low-advantaged area includes five districts (9, 10, 12, 14, 20), and the very low-advantaged area includes five districts (15, 16, 17, 18, 19). Two areas of low- and very low-advantaged will be selected according to the research goal. Then, the list of health centers in these two areas will be extracted based on their locations in the districts covered by Tehran University of Medical Sciences, including districts 10, 15, 16, 17, and 19, which include 100 centers. Next, among the health centers located in these districts, the centers which have capability to implement study better will be selected based on the criteria such as activeness of the center, cooperation of the center, sufficient number of clients, amount of participation of covered people, and facilities of the center including appropriate space and place for education. The list of selected health centers that are considered as clusters will be prepared, and from these selected centers, 20 centers will be randomly selected, of which 10 centers will be allocated to intervention group 1 (control) and 10 centers to intervention group 2 by simple randomization using Excel software. Then, according to the sample size of 400 people, in each of the 20 health centers, 20 people will be selected, in such a way that the list of people covered by these centers will be prepared, and 20 of them will be selected by simple random sampling and invited to participate in the study, and if people do not have willing to participate in the study, alternative people from the prepared list will be also selected by simple random sampling, Blinding description: The data will be entered into STATA software with special codes, so that the analyzer is not informed about the clusters and groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention of oral cancer.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Education on oral cancer prevention by educated health volunteers using two sessions of 10-15 minutes lecture presentation in form of PowerPoint slides, and presentation of pamphlet based on the structures of the Theory of Planned Behavior, with interactive group discussions, and questions and answers to questions. Intervention 2: Intervention group: Education on oral cancer prevention by educated health volunteers using information presentation on smartphone in form of educational and motivational messages, pictures, and videos in WhatsApp groups based on the structures of the Theory of Planned Behavior, with interactive group discussions, and questions and answers to questions.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anoosheh Ghasemian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>+98 21 8801 5950</telephone>
        <email>a-ghasemian@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Katayoun Sargeran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>+98 21 8801 5960</telephone>
        <email>k-sargeran@tums.ac.ir</email>
        <affiliation>Tehran 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>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 15 years and more
Living in low-advantaged or very low-advantaged area of Tehran
Absence of physical and mental disabling diseases
Minimum literacy of reading and writing
Having a smartphone and installed applications
Willingness to participate in the study and agreement to sign the informed consent form</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-Iranian citizens
Unwillingness to participate in face-to-face educational sessions
Unwillingness to work with virtual social networks
Inability to use smartphone applications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Education on oral cancer prevention by educated health volunteers using two sessions of 10-15 minutes lecture presentation in form of PowerPoint slides, and presentation of pamphlet based on the structures of the Theory of Planned Behavior, with interactive group discussions, and questions and answers to questions</i_keyword>
      <i_keyword>Intervention group: Education on oral cancer prevention by educated health volunteers using information presentation on smartphone in form of educational and motivational messages, pictures, and videos in WhatsApp groups based on the structures of the Theory of Planned Behavior, with interactive group discussions, and questions and answers to questions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive behaviors of oral cancer. Timepoint: At the beginning of study, one and three months after intervention. Method of measurement: Structured interviewer-administered questionnaire of Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Knowledge about oral cancer. Timepoint: َAt the beginning of study, one and three months after intervention. Method of measurement: Structured interviewer-administered questionnaire of Theory of Planned Behavior.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Behavioral intention about preventive behaviors of oral cancer. Timepoint: At the beginning of study, one and three months after intervention. Method of measurement: Structured interviewer-administered questionnaire of Theory of Planned Behavior.</sec_outcome>
      <sec_outcome>Attitude toward preventive behaviors of oral cancer. Timepoint: At the beginning of study, one and three months after intervention. Method of measurement: Structured interviewer-administered questionnaire of Theory of Planned Behavior.</sec_outcome>
      <sec_outcome>Subjective norm about preventive behaviors of oral cancer. Timepoint: At the beginning of study, one and three months after intervention. Method of measurement: Structured interviewer-administered questionnaire of Theory of Planned Behavior.</sec_outcome>
      <sec_outcome>Perceived behavioral control about preventive behaviors of oral cancer. Timepoint: At the beginning of study, one and three months after intervention. Method of measurement: Structured interviewer-administered questionnaire of Theory of Planned Behavior.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-21</approval_date>
        <contact_name>Ethics Committee of School of Dentistry, Tehran University of Medical Sciences</contact_name>
        <contact_address>Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
