<?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>IRCT20160824029512N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-05</date_registration>
      <primary_sponsor>Torbate-Heidaria University of Medical Sciences</primary_sponsor>
      <public_title>Family-centered educational intervention on iron deficiency anemia prevention behaviors</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family-centered theory-based intervention to increase preventive behaviors iron deficiency anemia on the primary students in Torbat Heydariyeh City</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59972</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Data collection is done in the form of a questionnaire that was interviewed by the researcher from mothers. It is a theory-based planning framework that evaluates and intervenes in health-related issues through an ecological approach. Intervention mapping to make the necessary changes at different ecological levels focuses on how to change the behavior of people at risk and environmental factors to make behavioral changes that lead to changes in health and quality of life, Randomization description: Randomization method and descriptions of each method: Layered randomization method with random assignment to intervention and control groups, followed by simple random sampling method with proportional assignment in each of the clusters of participants (mothers of first-year female students elementary School)
Randomization unit: Cluster
Randomization layers: First, all mothers of families with the first elementary school daughter of the study are classified among the invited participants in the study into subgroups with the same characteristics or characteristics, which are known as classes. From the classification groups, simple random sampling is performed, in which each element in the same subgroup is neutrally selected. During each stage of the sampling process, randomly and completely randomly.
Randomization tools: are selected with PASS statistical software randomization tools.
How to make a random sequence: To create a random sequence in the experiments of the two groups, one of the study groups is considered a lion and the other group is considered a line. They find it by accident.
Explanation of concealment: It is a double-blind randomization, Blinding description: Mothers with a first-year girl in primary school with an average age of 23 to 35 years because they are the booklet of the control group or the intervention is blinded and do not know and also the researcher does not know about the intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anemia.</hc_freetext>
      <i_freetext>Intervention 1: Educational intervention group: A group of mothers with the first daughter of the primary school is studied. An 8-member educational class is held in 9 different groups with group discussion and brainstorming to improve the intervention mapping approach. Intervention 2: Control group: There is a group of selected mothers from families living in Torbat-e Heydarieh city who are included in the study as mothers with first graders, but no educational intervention will be performed on them and as a control group to compare with the intervention group. , Will be examined.</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:
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    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hossien Delshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Ferdowsi Razi Razi 2, No. 14, 2nd floor</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9519633885</zip>
        <telephone>+98 51 5222 1508</telephone>
        <email>delshadmh1@thums.ac.ir</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad hossien Delshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdowsi St. Razi Razi St. 2, No. 14, 2nd Floor</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9519633885</zip>
        <telephone>+98 51 5222 1508</telephone>
        <email>h.delshad@modares.ac.ir</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Knowledge of research objectives, satisfaction with participation, having a first year girl in primary school, having 23 to 35 years of age in mothers</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction to participate in research
Incomplete completion of questionnaires</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iron deficiency anemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Educational intervention group: A group of mothers with the first daughter of the primary school is studied. An 8-member educational class is held in 9 different groups with group discussion and brainstorming to improve the intervention mapping approach.</i_keyword>
      <i_keyword>Control group: There is a group of selected mothers from families living in Torbat-e Heydarieh city who are included in the study as mothers with first graders, but no educational intervention will be performed on them and as a control group to compare with the intervention group. , Will be examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary outcome: Percentage of behaviors to prevent anemia in first grade female students of Torbat-e Heydarieh by mothers ", score of blood iron level test of first-year primary school girls" and "Percentage of regular physical activity by first grade female students in Torbat-e Heydarieh" Be. Definition of the percentage of preventive behavior: Performing the predicted health behavior means performing a health task continuously and consecutively for at least 6 months, after which the person can perform the health task without any problems. Definition of Blood Iron Levels: The amount of iron in a person's serum or blood. Definition of physical activity: Any activity or movement of the body that is caused by the contraction and expansion of skeletal muscles and requires energy is called physical activity. The use of iron tablets during pregnancy in mothers means the complete use of iron tablets during pregnancy and also other consequences include attitude score, studying the attitude to the concept of a person's belief about the desirability or undesirable behaviors to prevent anemia in female students in the class It is the first to be assessed based on existing and related questions in the study tool. Awareness of preventive behaviors and mothers' behavior. The mothers' knowledge about preventive behaviors of students' anemia, which will be measured based on their answers to the relevant questions in the questionnaire. Timepoint: Before, after and 6 months after intervention. Method of measurement: Self-reported questionnaire,Tools to prevent pediatric anemia behaviors according tointervention mapping protocol.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Torbate-Heidaria University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-26</approval_date>
        <contact_name>Torbat Heydariyeh Medical Sciences</contact_name>
        <contact_address>Torbat Heydariyeh, North Ferdowsi St., Razi Razi 2, No. 14, 2nd floor Torbat Heydariyeh Medical Sciences Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
