<?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>IRCT20220430054703N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-03</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention based on the TPB on reducing the consumption of plastic bags</public_title>
      <acronym></acronym>
      <scientific_title>Determining the effect of an intervention based on the Theory of Planned Behavior on promoting environmentally friendly behavior (Reducing Plastic Bag Consumption) in Health Volunteers in Zanjan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The subject of study is not a disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At first, 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. After reviewing the relevant texts, articles and journals, the questionnaire will be designed  based on TPB and its validity and reliability will be calculated through evaluation of  face validity, content validity (CVI, CVR), reliability (internal consistency).Then participants' perceptions about reducing the daily consumption of plastic bags will be measured based on the theory of planned behavior  and also their behavior will be measured by completing a questionnaire designed for this purpose. Then the educational intervention program is implemented. This program will be implemented within a month through WhatsApp social network and multimedia. In the next step, in order to determine the effectiveness of the educational intervention program,  participants' beliefs and behavior about reducing the daily consumption of plastic bag, three months after  intervention, will be measured again  through the same questionnaires. Intervention 2: Control group: At first, participants' perceptions about reducing the daily consumption of plastic bags will be measured based on the theory of planned behavior  and also their behavior will be measured by completing a questionnaire designed for this purpose. Then after three months participants' beliefs and behavior,  will be measured again  through the same questionnaire.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Somayeh Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Parvin E'tesamee Blvd., Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515786349</zip>
        <telephone>+98 24 3378 1300</telephone>
        <email>Sm8083667@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Hajimiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Parvin E'tesamee Blvd., Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515786349</zip>
        <telephone>+98 24 3378 1300</telephone>
        <email>hajimiri_kh@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Health Volunteer
Resident of Zanjan city
Have at least one year of experience as a health volunteer</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to continue cooperation for any reason
Failure to attend more than one training session
Intention to move during the intervention
Failure to complete questionnaires before and after the intervention.</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At first, 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. After reviewing the relevant texts, articles and journals, the questionnaire will be designed  based on TPB and its validity and reliability will be calculated through evaluation of  face validity, content validity (CVI, CVR), reliability (internal consistency).Then participants' perceptions about reducing the daily consumption of plastic bags will be measured based on the theory of planned behavior  and also their behavior will be measured by completing a questionnaire designed for this purpose. Then the educational intervention program is implemented. This program will be implemented within a month through WhatsApp social network and multimedia. In the next step, in order to determine the effectiveness of the educational intervention program,  participants' beliefs and behavior about reducing the daily consumption of plastic bag, three months after  intervention, will be measured again  through the same questionnaires.</i_keyword>
      <i_keyword>Control group: At first, participants' perceptions about reducing the daily consumption of plastic bags will be measured based on the theory of planned behavior  and also their behavior will be measured by completing a questionnaire designed for this purpose. Then after three months participants' beliefs and behavior,  will be measured again  through the same questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Environmental knowledge. Timepoint: Before and 3 months after the educational intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Attitude towards the behavior. Timepoint: Before and 3 months after the educational intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Subjective norm. Timepoint: Before and 3 months after the educational intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Perceived behavioral control. Timepoint: Before and 3 months after the educational intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
      <prim_outcome>Behavioral intention. Timepoint: Before and 3 months after the educational intervention. Method of measurement: Researcher made questionnaire based on the Theory of Planned Behavior.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduce the daily consumption of plastic bags. Timepoint: Before and 3 months after the intervention. Method of measurement: Researcher made questionnaire based on the 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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-07</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Azadi Blvd., Zanjan Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
