<?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>IRCT20200908048656N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-18</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The design, implementation and evaluation of The effect of educational campaign on smoking prevention behaviors based on protection motivation theory (PMT) in students</public_title>
      <acronym></acronym>
      <scientific_title>The design, implementation and evaluation of The effect of educational campaign on smoking prevention behaviors based on protection motivation theory (PMT) in  the students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50822</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Other design features: Implementation of an extensive educational campaign +community based.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention of smoking.</hc_freetext>
      <i_freetext>The method of conducting research in this research in 5 interconnected phases will be as follows: 1- Needs assessment and determination of the current situation 2- Construction of tools 3- Design of educational intervention (educational campaign) 4- Execution of educational program 5- Performing educational evaluation (pre- Test-post-test) To conduct a research project, people who meet the inclusion criteria will be selected to participate in the study. After selecting these people, the purpose of the study will be explained to them and then informed consent will be obtained. Phase 1: Needs Assessment and determining the status of this stage, first the necessary communication to form a planning team with Key people, established with influence and experts. The projected members fall into two categories. The first category of this team includes key decision makers and those in power (student-related officials) including university deans, deans, security guards of the governorate university, municipality, health deputy and city health center, representative of the Radio and Television Organization, faculty members and members Faculty, predecessors of the university, seller of the university or college store, service managers; The second group of volunteer students and the student committee, which will be the same members of the target community, ie the representatives of the students of each university. The role of this group is to provide advice, support, participation in the program design, implementation and evaluation stages. The group will also have effective oversight of intervention strategies and training materials in terms of eloquence, cultural appropriateness and comprehensiveness, manner and duration of intervention, and selection and use of facilitators. During the group meetings that will be held, the goals of the program and the role of organizations and individuals in this program will be explained to the members of the planning team.Phase 2: Instrumentation Then the data related to the stages of face validity, content validity (CVI, CVR), reliability (internal consistency) and determination of the structures of predictors of protection motivation theory are done. Questionnaire After reviewing the relevant texts, articles and journals, a questionnaire will be designed accordingly, its validity and reliability will be obtained through a panel of experts. This questionnaire has 2 parts; The first part of demographic characteristics (including: age, grade point average, parents 'education level, smoking in the student - parents and friends of parents' occupation, residence status, native and non-native, financial status, etc.), the second part of the researcher questionnaire The construct will be designed and completed based on the theory of protection motivation. The analysis of the results in the descriptive section will identify the main components of the intervention. Interventions and messages designed in a session with the presence of the planning team and a number of members of the target community, will be pre-tested and examined by factors such as audience perception of the message, relevance to the level of education and culture of the audience, attractiveness, credibility and acceptance as The final message will be considered.Phase 3: Designing an educational intervention (educational campaign) to start entering the target community and better access to the target group and also to help implement interventions in the target group, people will be selected and trained as facilitators. These people from both groups will be selected voluntarily to work with the presenter with the necessary interest and motivation in all stages of the program. Campaigns: One of the strategies of community-based training programs is health information mobilization (campaign), which has increased in recent years and aims to convey persuasive messages to perform specific behaviors in the target group. A set of coordinated information, communication and educational activities using a combination of multiple and diverse information channels in order to convey the desired and specific messages to a specific population in a specific and limited period in line with the objectives of the program to mobilize information Say. Health campaigns invite people and officials to participate publicly and to pay attention to the common good, but it cannot achieve this goal if the information is not correct. The campaign measures include two categories: 1- Action to strengthen the collective action of engaging with partner organizations in health: to prevent and reduce smoking through holding joint coordination meetings to increase cross-sectoral cooperation and coordinated action between organizations Related to health (municipality, radio and television, health deputy, deans of universities, colleges, faculty members, etc.) and their participation. 2- Facilitators' cooperation with the facilitator: Holding educational sessions with educational methods used in educational classes based on lectures along with PowerPoint, questions and answers, group discussions with showing videos and photos related to the harmful effects of smoking on a person's health and Secondhand smoke for those around you and a risk factor for increasing the risk of coronary heart disease, forming self-help groups to educate peers and reducing the target group's access to cigarettes.Phase 4: Implementation of the educational program In this section, the designed educational intervention (educational campaign) will be implemented on the students of the studied universities. The statistical population of the study includes all students studying at Yazd universities in the academic year 1399-1400 (which is approximately equal to 43,600 people. The sample size considering the significance level of 5% and test power 80% and according to the study Similar and standard deviation of preventive behavior score s = 1.5 and to achieve a significant difference of at least 7 units in the mean score of behavior in the intervention group compared to the control of 265 people, which with 10% of the fall, 300 people in each group will be calculated Sampling is probably a multi-stage random class in that after preparing a list of university names in a random class, three selected universities including a national non-medical university, a medical university and a free university Or non-profit are selected, then one faculty in each university is randomly determined and after preparing a list of graduate and faculty education department, students will be selected by random sampling method and this sample size is 300 people according to the university population. Will be divided and thus the random sample size with the names in hand Students required for research will be selected. With the data collection tool (researcher-made questionnaire), a pre-test will be conducted of students eligible to enter the study, and then based on the design, an educational campaign will be conducted and designed interventions and messages that include messages- Designed to mobilize information (campaign) in the lesson plan (including the use of mass media, health exhibitions, competitions, walking conferences, lectures with PowerPoint, group discussions, pamphlets, posters and text messages, online education and spaces Virtual, etc.) will be implemented for one month with the participation of facilitators. Phase 5: Educational evaluation will be done two months after the intervention of the post-test educational campaign based on the questionnaire of protection motivation theory and the collected results of the educational campaign on The basis is compared and analyzed before and after the educational campaign, and in order to evaluate the effect of implementing programs designed to prevent the second type in smoking students, in addition to performing post-test in them, measuring the salivary cotinine level of smoking students and comparing before and after The training will be done using appropriate statistical tests..</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:
Demographic data of study participants + total potential data after unidentifiable individuals

When:
1399

To whom:
Everyone and everyone who needs data.

Conditions:
Unidentifiable personal data or other documentation

Where to obtain:
Researcher articles and dissertation

How to obtain:
No process

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Salime Zare Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No .62,koy Vahdat ,West Azadshahr.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917864633</zip>
        <telephone>+98 35 3721 3280</telephone>
        <email>salimezare2319@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Salime Zare Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No .62,koy Vahdat ,West Azadshahr.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917864633</zip>
        <telephone>+98 35 3721 3280</telephone>
        <email>salimezare2319@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being a student
Attend college at least until the end of the research
The student's desire to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Their unwillingness to participate in research
Drug addiction
Being a student for less than six months
Absence from more than 10% of training sessions</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The method of conducting research in this research in 5 interconnected phases will be as follows: 1- Needs assessment and determination of the current situation 2- Construction of tools 3- Design of educational intervention (educational campaign) 4- Execution of educational program 5- Performing educational evaluation (pre- Test-post-test) To conduct a research project, people who meet the inclusion criteria will be selected to participate in the study. After selecting these people, the purpose of the study will be explained to them and then informed consent will be obtained. Phase 1: Needs Assessment and determining the status of this stage, first the necessary communication to form a planning team with Key people, established with influence and experts. The projected members fall into two categories. The first category of this team includes key decision makers and those in power (student-related officials) including university deans, deans, security guards of the governorate university, municipality, health deputy and city health center, representative of the Radio and Television Organization, faculty members and members Faculty, predecessors of the university, seller of the university or college store, service managers; The second group of volunteer students and the student committee, which will be the same members of the target community, ie the representatives of the students of each university. The role of this group is to provide advice, support, participation in the program design, implementation and evaluation stages. The group will also have effective oversight of intervention strategies and training materials in terms of eloquence, cultural appropriateness and comprehensiveness, manner and duration of intervention, and selection and use of facilitators. During the group meetings that will be held, the goals of the program and the role of organizations and individuals in this program will be explained to the members of the planning team.Phase 2: Instrumentation Then the data related to the stages of face validity, content validity (CVI, CVR), reliability (internal consistency) and determination of the structures of predictors of protection motivation theory are done. Questionnaire After reviewing the relevant texts, articles and journals, a questionnaire will be designed accordingly, its validity and reliability will be obtained through a panel of experts. This questionnaire has 2 parts; The first part of demographic characteristics (including: age, grade point average, parents 'education level, smoking in the student - parents and friends of parents' occupation, residence status, native and non-native, financial status, etc.), the second part of the researcher questionnaire The construct will be designed and completed based on the theory of protection motivation. The analysis of the results in the descriptive section will identify the main components of the intervention. Interventions and messages designed in a session with the presence of the planning team and a number of members of the target community, will be pre-tested and examined by factors such as audience perception of the message, relevance to the level of education and culture of the audience, attractiveness, credibility and acceptance as The final message will be considered.Phase 3: Designing an educational intervention (educational campaign) to start entering the target community and better access to the target group and also to help implement interventions in the target group, people will be selected and trained as facilitators. These people from both groups will be selected voluntarily to work with the presenter with the necessary interest and motivation in all stages of the program. Campaigns: One of the strategies of community-based training programs is health information mobilization (campaign), which has increased in recent years and aims to convey persuasive messages to perform specific behaviors in the target group. A set of coordinated information, communication and educational activities using a combination of multiple and diverse information channels in order to convey the desired and specific messages to a specific population in a specific and limited period in line with the objectives of the program to mobilize information Say. Health campaigns invite people and officials to participate publicly and to pay attention to the common good, but it cannot achieve this goal if the information is not correct. The campaign measures include two categories: 1- Action to strengthen the collective action of engaging with partner organizations in health: to prevent and reduce smoking through holding joint coordination meetings to increase cross-sectoral cooperation and coordinated action between organizations Related to health (municipality, radio and television, health deputy, deans of universities, colleges, faculty members, etc.) and their participation. 2- Facilitators' cooperation with the facilitator: Holding educational sessions with educational methods used in educational classes based on lectures along with PowerPoint, questions and answers, group discussions with showing videos and photos related to the harmful effects of smoking on a person's health and Secondhand smoke for those around you and a risk factor for increasing the risk of coronary heart disease, forming self-help groups to educate peers and reducing the target group's access to cigarettes.Phase 4: Implementation of the educational program In this section, the designed educational intervention (educational campaign) will be implemented on the students of the studied universities. The statistical population of the study includes all students studying at Yazd universities in the academic year 1399-1400 (which is approximately equal to 43,600 people. The sample size considering the significance level of 5% and test power 80% and according to the study Similar and standard deviation of preventive behavior score s = 1.5 and to achieve a significant difference of at least 7 units in the mean score of behavior in the intervention group compared to the control of 265 people, which with 10% of the fall, 300 people in each group will be calculated Sampling is probably a multi-stage random class in that after preparing a list of university names in a random class, three selected universities including a national non-medical university, a medical university and a free university Or non-profit are selected, then one faculty in each university is randomly determined and after preparing a list of graduate and faculty education department, students will be selected by random sampling method and this sample size is 300 people according to the university population. Will be divided and thus the random sample size with the names in hand Students required for research will be selected. With the data collection tool (researcher-made questionnaire), a pre-test will be conducted of students eligible to enter the study, and then based on the design, an educational campaign will be conducted and designed interventions and messages that include messages- Designed to mobilize information (campaign) in the lesson plan (including the use of mass media, health exhibitions, competitions, walking conferences, lectures with PowerPoint, group discussions, pamphlets, posters and text messages, online education and spaces Virtual, etc.) will be implemented for one month with the participation of facilitators. Phase 5: Educational evaluation will be done two months after the intervention of the post-test educational campaign based on the questionnaire of protection motivation theory and the collected results of the educational campaign on The basis is compared and analyzed before and after the educational campaign, and in order to evaluate the effect of implementing programs designed to prevent the second type in smoking students, in addition to performing post-test in them, measuring the salivary cotinine level of smoking students and comparing before and after The training will be done using appropriate statistical tests.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge, attitude and practice score and structures of protection motivation model (PMT) - Reduce students' exposure to smoking - Percentage of smoking students. Timepoint: Before the intervention of the educational campaign with questionnaires and tests. Method of measurement: Protection Motivation Questionnaire + Salivary cotinine test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lifestyle Improvement - Prevent health problems such as cancer, increase cardiovascular disease and other chronic diseases, reduce treatment costs and increase life expectancy. Timepoint: 3 months after the training campaign. Method of measurement: Protection Motivation Questionnaire + saliva cotinine test.</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>2020-09-29</approval_date>
        <contact_name>School of Public Health - Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>No. 62, Sarnabesh, Second Crossroads, Vahdat Alley, Between First and Second Square, Azadshahr St., Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
