<?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>IRCT20190626044024N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-05</date_registration>
      <primary_sponsor>UCSI University</primary_sponsor>
      <public_title>Hands-on healthy meal preparation in improving children's nutritional outcomes</public_title>
      <acronym>KidChen (Kids in Kitchen)</acronym>
      <scientific_title>KidChen Study: Randomized-controlled trial of experiential healthy meal preparation among children in improving nutritional outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40804</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Stratified random sampling will be used in which one out of the total of three zones in Kuala Lumpur, Malaysia will be randomly selected. Then simple random sampling will be used whereby two primary schools will be randomly selected from the randomly selected zone. Both schools will then be randomly assigned to either intervention or control group. Finally, we will randomly select 48 children from each school. For randomization, we will use the Research Randomizer, Blinding description: Participants will be blinded in the study. Children will not know whether they are in intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knowledge, attitude, practice and self-efficacy for healthy meal preparation, food consumption pattern and body composition.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: . Intervention 2: Control group: .</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ng Choon Ming</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur</address>
        <city>Cheras, KL</city>
        <country1>Malaysia</country1>
        <zip>56000</zip>
        <telephone>+60 10-362 7511</telephone>
        <email>ngchoonming23@gmail.com</email>
        <affiliation>UCSI University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Satvinder Kaur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip>56000</zip>
        <telephone>+60 16-202 9941</telephone>
        <email>satvinderkaur@ucsiuniversity.edu.my</email>
        <affiliation>UCSI University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Malaysian children aged 9-11.
Able to read, write and understand English/Malay language.
Children that voluntarily participate, with their parent’s consent.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with food allergies (eg: wheat/gluten, dairy, or peanuts)
Children with any serious co-morbidity/learning disabilities</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>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: </i_keyword>
      <i_keyword>Control group: </i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge, attitude, practice and self-efficacy for healthy meal preparation. Timepoint: 2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up. Method of measurement: Reliable and valid questionnaire.</prim_outcome>
      <prim_outcome>Food consumption pattern. Timepoint: 2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up. Method of measurement: Reliable and validated questionnaire.</prim_outcome>
      <prim_outcome>Home food availability. Timepoint: 2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up. Method of measurement: Reliable and valid questionnaire.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: 2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up. Method of measurement: BMI z-score: Tanita SC-330 for weight and stadiometer Seca 203 for height; waist circumference: measuring tape; body fat percent: Tanita SC-330.</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>UCSI University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-04</approval_date>
        <contact_name>Medical Research and Ethics Committee (MREC), Malaysia</contact_name>
        <contact_address>Kompleks Institut Kesihatan Negara Blok A, No 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170 Shah Alam, Selangor. Selangor Selangor Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
