<?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>IRCT20230424057980N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-12</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of educational intervention on the promotion of arthritis prevention behaviors in middle-aged women is a combination of health belief model and social cognitive theory in the intervention group and the control group, and the intervention takes place in several training sessions, and after the intervention two weeks and 3 months later Questionnaires are completed.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of educational intervention on the promotion of arthritis prevention behaviors in middle-aged women is a combination of health belief model and social cognitive theory in the intervention group and the control group, and the intervention takes place in several training sessions, and after the intervention two weeks and 3 months later Questionnaires are completed.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69747</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: In this study, sampling is done in two stages, so that at first two centers are selected from among 10 centers and comprehensive health service base of Barazjan city by simple random method (lottery) and then one is selected randomly from among the two centers. The center is considered for the implementation of the educational intervention and the other as the control. Then, by referring to the two selected centers, the study begins.
After entering the centers and for sampling from the selected centers, the names of middle-aged women (30 to 59 years old) are extracted through the integrated health system (SIB) and after that the summary of their electronic file is checked for evaluation and this list is prepared and It will enter the Excel file. In the following, from the beginning of the list prepared based on the names of women who meet the criteria for entering the study, they will be contacted randomly and will be checked for the study and also their willingness to participate in the study. This process continues until the required sample volume is reached. In this way, a sample with the necessary volume of all women who meet the criteria for entering the study will be prepared and they will be invited to register in the research as the final sample.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigating the effect of educational intervention on arthritis prevention behaviors among middle-aged women of Borazjan city: a synthesis of health belief model and social cognitive theory.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: they are given face-to-face training in 6 sessions..</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnoosh Raisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr province - Bushehr city - Bushehr University of Medical Sciences</address>
        <city>Borazjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7561869133</zip>
        <telephone>+98 77 3425 1757</telephone>
        <email>َangalidehnoei@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnoosh Raisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr Province - Barazjan City - Irshad St</address>
        <city>Borazjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7561869133</zip>
        <telephone>+98 77 3425 1757</telephone>
        <email>angalidehnoei@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People aged 30 to 59 years
Having health records in comprehensive health service centers
Being literate in reading and writing
Living in Barazjan city
Not having cognitive, perceptual and mental health problems based on people's health records
Not having a medical prohibition (physical disability such as amputation of the lower limb)
Absence of pregnancy and breastfeeding
Willingness to participate in the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy and breastfeeding
People under 30 years old and over 59 years old
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>مطالعه من </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>مطالعه من تاثیر مداخله آموزش بر رفتارهای پیشگیری کننده از آرتروز می باشد.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: they are given face-to-face training in 6 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behaviors that prevent arthritis. Timepoint: Measurement at the beginning of the study and 2 weeks and 3 months. Method of measurement: It is a questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Consciousness. Timepoint: At the beginning of the study and 2 weeks and 3 months. 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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-25</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Bushehr province, Barazjan city, Irshad street, 9 Irshad street, door 5 Borazjan Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-25</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Bushehr province - Barazjan city - Irshad street - Irshad alley 9 Borazjan Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
