<?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>IRCT20180528039885N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-30</date_registration>
      <primary_sponsor>Research Deputy of Tarbiat Modares University</primary_sponsor>
      <public_title>Effectiveness of a theory-based educational program on healthy spine-related behavior</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of a  theory-based educational program on healthy spine-related behavior among female fifth grade elementary school - Randomized Community  Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31534</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Because the trial is done on the group and the community ,in the first stage of the sampling process, a list of schools in the study location was prepared which included nine schools  in the study location.
As the second step, two schools of 9 schools -which is similar In terms of social class  and the number of students in the class- are randomly assigned to the intervention and control groups using the simple random sampling technique .
As the final step, two classes of fifth grade  in each school - 51 students regarding the inclusion and exclusion criteria - are randomly selected  to enter the study .</study_design>
      <phase>N/A</phase>
      <hc_freetext>back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Includes 51 people who receive 6 sessions of instructional education program based on social cognitive theory.       Two strategies( 3 sessions) are used to increase the behavioral capability(knowledge and skills):- Provide required knowledge to conduct recommended behavior using lecture, slide show and  brain storm           2- Teaching essential skills for accepting the behavior and keeping it using the direct  and  vicarious experience and demonstration- re demonstration  method             In order to increase self-efficacy are used (2  sessions)  , methods of mastering the practice, observing others' performance, receiving suggestions from others, and confronting emotions arising from thoughts of change .                  To enhance the fear-avoidance beliefs (1  sessions) are used the methods of discussing about benefit, brainstorm , and role playing . Intervention 2: Control group: Includes 51 people  (two classes) who are in the same school as the intervention group and do not receive any training.</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:


When:
31/ 09/2020

To whom:
The person who evaluates the outcome - Analytic person - Journal Reviewer - executor of plan

Conditions:
To evaluate the outcome, data analysis and validation of data - Under the conditions of the triple-blind

Where to obtain:
executor of plan

How to obtain:
It is requested by e-mail to the project implementer with the address: tavafian@modares.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sediqh al-Sadat Tawafian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University,Jalal Al Ahmad, Paul Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Department of Health Education,Faculty of Medical Sciences, Tarbiat Modares University  ،</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sediqh al-Sadat Tawafian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education ,School of Medical Sciences,Tarbiat Modares University, Jalal Allahmad, Paul Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 8288 3590</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Department of Health Education, Faculty of Medical Sciences,  Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female fifth grade elementary school
Parents informed consent
Student informed consent and voluntary  participation
Ability to attend training sessions
No training in this area</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>11 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receive back pain prevention  programs before or outside of this study
Any reports of pain or  disorder  in the student's spine by him or her, parents or school officials
Report of student's spine unhealthy  by physiotherapist</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: Includes 51 people who receive 6 sessions of instructional education program based on social cognitive theory.       Two strategies( 3 sessions) are used to increase the behavioral capability(knowledge and skills):- Provide required knowledge to conduct recommended behavior using lecture, slide show and  brain storm           2- Teaching essential skills for accepting the behavior and keeping it using the direct  and  vicarious experience and demonstration- re demonstration  method             In order to increase self-efficacy are used (2  sessions)  , methods of mastering the practice, observing others' performance, receiving suggestions from others, and confronting emotions arising from thoughts of change .                  To enhance the fear-avoidance beliefs (1  sessions) are used the methods of discussing about benefit, brainstorm , and role playing .</i_keyword>
      <i_keyword>Control group: Includes 51 people  (two classes) who are in the same school as the intervention group and do not receive any training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healthy spine-related behavior. Timepoint: before, Immediate, three and six months after the intervention. Method of measurement: Using a questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge, Skill, Self-efficacy and Belief. Timepoint: before, Immediate, three and six months after the intervention. Method of measurement: Using a  performance checklist.</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>Research Deputy of Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-17</approval_date>
        <contact_name>Ethics Committee in Tarbiat Modarres University</contact_name>
        <contact_address>Tarbiat Modarres University, Jalal Ahmad Highway, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
