<?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>IRCT20220128053843N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-22</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>educational nutrition package based on group play therapy for preschool children</public_title>
      <acronym></acronym>
      <scientific_title>Measuring the Effectiveness of Group-Based Proper Nutrition-Training Therapy on Tendency to Food Diversity and Anxiety in Preschool Children with Avoidance / Restriction Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61621</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 30 identified children with avoidance disorder / food restriction; They were organized in 2 groups of 15 (experimental and control) by simple randomization method. The following random number table was used for randomization:
First, the researcher's colleague determined to read the numbers in the table, from top to bottom. Next, he considered odd numbers for the experimental group and even numbers for the control group. Then he put his hand on one of the numbers and moved from top to bottom and recorded the numbers and assigned them to the experimental and control groups, Blinding description: In a completely randomized manner, children were divided into two groups, in which the researcher did not know. But after dividing and forming groups because of 10 sessions, education is accepted by the plan of the plan, it is inevitably aware of the type of treatment. Children were notified after the formation of groups, which program is supposed to be implemented. Only an analysis of none of the processes, so the one-blind study will be.</study_design>
      <phase>3</phase>
      <hc_freetext>Avoidant-Restrictive Food Intake Disorder (ARFID).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention started with 2 group training sessions for mothers in the experimental group. Therapeutic group of young children with eating disorders; It requires the cooperation and serious participation of their mothers in the treatment process. For this reason, in the intervention, 2 sessions are provided for educating mothers. In the first session, parenting style and child nutrition were taught, and in the next session, a number of package therapy games were introduced and taught to mothers. The experimental group then received 120 minutes of 120 minutes of group nutrition training through play therapy. The titles of the intervention sessions are as follows:Healthy eating, dietary diversity, adding healthy eating concepts to the vocabulary, recognizing anxiety and relaxation education, developing interest in a variety of foods, teaching nutritional skills and eating habits, teaching problem-solving skills, preventing relapse .In each session, 2 games were played with children, and the names of the games are as follows:Knowing the types of food, dream pillows, guests playing and setting the table, breathing journey, what is wrong? I'm a turtle, an agricultural truck, pasta, playing card games, making bubbles, making a healthy meal, breathing gig, storytelling with pictures, running after talking, popcorn and the five senses. Intervention 2: Control group: The control group did not receive any 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of the data, such as the main outcome, can be shared

When:
Start of access period 1 month after printing the results

To whom:
Anyone can

Conditions:
Use of data, citing the source

Where to obtain:
Email me
aboubakr.karimi@yahoo.com

How to obtain:
Up to one week after receiving the application, which will be sent to me via email, the files will be sent to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aboubakr Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shayan 10 Ave, Farhangiyan- Saheli</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616978156</zip>
        <telephone>+98 87 3373 2001</telephone>
        <email>aboubakr.karimi@yahoo.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aboubakr Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saheli</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616978156</zip>
        <telephone>+98 87 3373 2001</telephone>
        <email>aboubakr.karimi@yahoo.com</email>
        <affiliation>Kurdistan Governorate</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having DSM5-based criteria for avoiding / avoiding eating disorders (such as being low in weight and energy and having some anxiety)
Children whose scores on each subscale of the Eating or Avoidance Problems Questionnaire are a standard deviation above average
Children who do not have a clear physical illness
They are between 3 and 5 years old
Failure to receive concomitant drug therapy for research purposes</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who have been on medication, such as those taking anti-anxiety medications
Absence from more than two sessions in psychotherapy sessions.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention started with 2 group training sessions for mothers in the experimental group. Therapeutic group of young children with eating disorders; It requires the cooperation and serious participation of their mothers in the treatment process. For this reason, in the intervention, 2 sessions are provided for educating mothers. In the first session, parenting style and child nutrition were taught, and in the next session, a number of package therapy games were introduced and taught to mothers. The experimental group then received 120 minutes of 120 minutes of group nutrition training through play therapy. The titles of the intervention sessions are as follows:Healthy eating, dietary diversity, adding healthy eating concepts to the vocabulary, recognizing anxiety and relaxation education, developing interest in a variety of foods, teaching nutritional skills and eating habits, teaching problem-solving skills, preventing relapse .In each session, 2 games were played with children, and the names of the games are as follows:Knowing the types of food, dream pillows, guests playing and setting the table, breathing journey, what is wrong? I'm a turtle, an agricultural truck, pasta, playing card games, making bubbles, making a healthy meal, breathing gig, storytelling with pictures, running after talking, popcorn and the five senses.</i_keyword>
      <i_keyword>Control group: The control group did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Trends in children's food diversity based on Wardell, Guthrie, Sanderson and Rapaport (2001) Children Eating Behavior Questionnaire. Timepoint: Before intervention, after intervention, one month after intervention. Method of measurement: The Wardell, Guthrie, Sanderson, and Rapaport (2001) Children Eating Behavior Questionnaire was used.</prim_outcome>
      <prim_outcome>Reducing Child Anxiety Based on the Revised Childhood Anxiety Scale (CMAS) by Reynolds and Richmond (1987). Timepoint: Before intervention, after intervention, one month after intervention. Method of measurement: The Revised Child Anxiety Scale (CMAS) by Reynolds and Richmond (1987) has been used.</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>Iranian academic center for education culture and research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-20</approval_date>
        <contact_name>Research Ethics Committee of Payame Noor University</contact_name>
        <contact_address>saheli- Farhangian Town - Shayan Alley 10 Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
