<?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>IRCT201504061126N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-17</date_registration>
      <primary_sponsor>Gilan University of Medical Sciences</primary_sponsor>
      <public_title>Intervention Based On Health Belief Model On Osteoporosis   Preventive Behaviors</public_title>
      <acronym></acronym>
      <scientific_title>Survey The Effect Of  Educational  Intervention Based On Health Belief Model On Osteoporosis   Preventive Behaviors  Of  Health Volunteers  Of Community   Health Centers In Rasht  City In  2016-2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoprosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: After the pre-test in both groups, of participating Health Volunteers in the intervention group will be invited to participate in eight educational sessions (during four weeks). Educational program will be hold based on health belief model, Speeches, group discussions, Pamphlets and educational video.Immediatly and one months after end of the program, from each group will be taken post-test and the results will be compared. Intervention 2: Control Group: no intervention.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Zarat Dakheliparast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht Health center, Sadi Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41576-79464</zip>
        <telephone>+98 13 3312 9302</telephone>
        <email>lszarat51@gmail.com; nasrin.lakeh@gmail.com; mfarokhmanesh@gmail.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Mokhtari Lakeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Daneshjoo street, Shahid beheshti road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93345- 41938</zip>
        <telephone>+98 13 3555 5056</telephone>
        <email>Nasrin.lakeh@gmail.com; mfarokhmanesh@gmail.com; lszarat51@gmail.com</email>
        <affiliation>Gilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: having a health volunteer Card from the community health center; active participation in community health center training session; willingness to participate in the study; not having specific illness.&#13;
Exclusion criteria: not wanting to continue participation in the study intervention; absence from training sessions; occurrence of specific illness or events during the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>66 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M82.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: After the pre-test in both groups, of participating Health Volunteers in the intervention group will be invited to participate in eight educational sessions (during four weeks). Educational program will be hold based on health belief model, Speeches, group discussions, Pamphlets and educational video.Immediatly and one months after end of the program, from each group will be taken post-test and the results will be compared.</i_keyword>
      <i_keyword>Control Group: no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adopt behaviors to prevent osteoprosis. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived susceptibility. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived severity. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived benefits. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived barriers. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Self-efficacy. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Cues of action. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Nutritional behavior. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire FFQ.</sec_outcome>
      <sec_outcome>Physical activity behavior. Timepoint: Before, immediatly and one mounth after the intervention educationa. Method of measurement: Questionnaire IPAQ.</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>Gilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-17</approval_date>
        <contact_name>Guilan University of Medical Sciences</contact_name>
        <contact_address>Guilan University of Medical Sciences, Namjoo St. Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
