<?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>IRCT20130317012830N33</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-02</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Health Video game</public_title>
      <acronym></acronym>
      <scientific_title>Effect  of  Health video games on anthropometry and promotion of Intrinsic motivation, self-efficacy and Preference Diet  patterns and motor activity in 9-12 year old students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34904</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Of the total research community (students aged 9 to 12), we select samples in a multi-stage approach. In this sampling, we first select random numbers (random numbered Excel) from among the elementary schools in  Bushehr and then select from a randomly selected random class (Excel random number table) and then Of the selected classes, a number of students are divided into two groups of test and control using the permutation block method. A total of 128 people (64 control groups and 64 test groups) are enrolled in the study, Blinding description: In this study, data researcher and analyst are blind. At first, pre -tests are collected from both groups and game information is given in envelopes depending on the children. The same packets are given to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preventing Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this research, a researcher-made video game will be used; this video game will use healthful 3D collections and animated characters to tell stories, according to numerous text and review reviews and guides. Supervisor professors, bookstores and various scientific articles and games in this field will be made in other countries and not having a similar sample in Iran. The game will be run in 8 sessions; each session will play about 40 minutes It will take time.At each stage of the game it is not possible to go to the next stage; after the specified time for each stage, it is possible to advance to the next stage. Companies in the test group will play a video game at home according to the program of remembrance, both Such a researcher will be telephoned with his parents (to remind them of the game). According to the research objectives, anthropometric indicators will be measured.Measuring the weight with the least amount of clothing without shoe will be done with a digital scale of SKAA with a precision of 100 grams. Measuring people's height using a wall-mounted Scythian scanner with a precision of 0.1 cm in the face standing, beside the wall and without shoes. While the shoulders are in normal position and waist circumference in the narrowest area. Measuring the weight of all students will be measured at a specified hour. Intervention 2: Control group: There is no intervention for the control group. Anthropometric indicators will be measured according to the research objectives. Measuring the weight with the least amount of clothing without shoe will be done with a digital scale of SKAA with a precision of 100 grams. Measuring people's height using a wall-mounted Scythian scanner with a precision of 0.1 cm in the face standing, beside the wall and without shoes. While the shoulders are in normal position and waist circumference in the narrowest area. Measuring the weight of all students will be measured at a specified hour.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh Jahanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 33 3345 0178</telephone>
        <email>f.jahanpour@bpums.ac.ir</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faezeh Jahanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>f_jahanpour@bpums.ac.ir</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All students aged 9-12 years
Interest in playing video games
Having a mobile or tablet
Having BMI Between Percentiles Fifty to Ninety-Five</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a physical illness like seizure disorders
Having a special diet</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>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this research, a researcher-made video game will be used; this video game will use healthful 3D collections and animated characters to tell stories, according to numerous text and review reviews and guides. Supervisor professors, bookstores and various scientific articles and games in this field will be made in other countries and not having a similar sample in Iran. The game will be run in 8 sessions; each session will play about 40 minutes It will take time.At each stage of the game it is not possible to go to the next stage; after the specified time for each stage, it is possible to advance to the next stage. Companies in the test group will play a video game at home according to the program of remembrance, both Such a researcher will be telephoned with his parents (to remind them of the game). According to the research objectives, anthropometric indicators will be measured.Measuring the weight with the least amount of clothing without shoe will be done with a digital scale of SKAA with a precision of 100 grams. Measuring people's height using a wall-mounted Scythian scanner with a precision of 0.1 cm in the face standing, beside the wall and without shoes. While the shoulders are in normal position and waist circumference in the narrowest area. Measuring the weight of all students will be measured at a specified hour.</i_keyword>
      <i_keyword>Control group: There is no intervention for the control group. Anthropometric indicators will be measured according to the research objectives. Measuring the weight with the least amount of clothing without shoe will be done with a digital scale of SKAA with a precision of 100 grams. Measuring people's height using a wall-mounted Scythian scanner with a precision of 0.1 cm in the face standing, beside the wall and without shoes. While the shoulders are in normal position and waist circumference in the narrowest area. Measuring the weight of all students will be measured at a specified hour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Promotion Diet  patterns ( Intrinsic motivation, self-efficacy and Preference ). Timepoint: Before intervention; immediately after intervention;  6 weeks after intervention;  6 months after intervention. Method of measurement: Diet  patterns Questionnaire:  To assess food patterns, three questionnaires (Preference  , intrinsic motivation and self-efficacy) will be used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Promotion motor activity( Intrinsic motivation, self-efficacy and Preference ). Timepoint: Before the intervention; immediately after the intervention; 6 weeks after the intervention; and 6 months after the game . Method of measurement: To assess motor activity, three questionnaires (Preference questionnaire, intrinsic motivation and self-efficacy) were used.</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>2018-10-30</approval_date>
        <contact_name>Ethics Committee Bushehr University of Medical Sciences</contact_name>
        <contact_address>No. 12, Bahmani, Yasini Avenue,Bushehr University of Medical Sciences Campus, Bushehr, Iran Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
