<?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>IRCT20190417043296N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-19</date_registration>
      <primary_sponsor>University Putra Malaysia</primary_sponsor>
      <public_title>HYGIENE PRACTICE AMONG PRIMARY CAREGIVERS OF INDIGENOUS GROUP</public_title>
      <acronym></acronym>
      <scientific_title>INTERVENTION TO IMPROVE HYGIENE PRACTICE AMONG PRIMARY CAREGIVERS OF ORANG ASLI (INDIGENOUS) CHILDREN UNDER THREE YEARS OLD IN KUALA LANGAT DISTRICT, SELANGOR</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>186</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38919</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Randomization at individual level was not conducted, but instead at the cluster level (4 health clinics) by randomly allocate the clusters equally into intervention and control groups (1:1).  All respondents who met the inclusion criteria were included in the study. All respondents listed from both health clinics and head of village lists were contacted and invited to participate in the study during their follow up mobile clinic.  Four (4) clusters were sequentially numbered (number 1 to 4) on a piece of paper and kept in a concealed envelope. An independent person, the head of staff nurses (Matron) from the District Health Office who was not involved in this study was asked to carry out the randomization procedure. Four numbers were generated using the random sequence number generator where each cluster had an equal chance to either be in the intervention or control group (http://www.randomiser.org), Blinding description: This is a single blinded study whereby only the investigators not the respondents know the which cluster receive the intervention or being the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The study is a preventive medicine study to improve hygiene practice among primary caregivers of Orang Asli (indigenous) children.</hc_freetext>
      <i_freetext>Intervention 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Effectiveness of IMB based intervention on hygiene practice among primary caregivers of Orang Asli children in Kuala Langat District

When:
After the data has been published

To whom:
people working in public health area

Conditions:
Data on change of hygiene practice within and between trial groups post intervention will be shared. The request will be reviewed by the correspondence through email.

Where to obtain:
The data can be requested through email to the correspondence Ass Prof Halimatus Sakdiah Minhat via email at halimatus@upm.edu.my

How to obtain:
The data can be requested through email to the correspondence of the study which will be replied accordingly.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Liyanatul Najwa Zakaria</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17, Jalan Mawar, Taman Mawar</address>
        <city>Sepang</city>
        <country1>Malaysia</country1>
        <zip>43900</zip>
        <telephone>+60 3-8705 3873</telephone>
        <email>liyanatul.zakaria@gmail.com</email>
        <affiliation>University of Putra Malaysia</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ass Prof Halimatus Sakdiah Minhat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>FAKULTI PERUBATAN DAN SAINS KESIHATAN, UPM</address>
        <city>Serdang</city>
        <country1>Malaysia</country1>
        <zip>43400</zip>
        <telephone>+60 3-8947 2413</telephone>
        <email>halimatus@upm.edu.my</email>
        <affiliation>University of Putra Malaysia</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primary caregivers with at least one  Orang Asli children aged between 6 months to  3 years old
Primary caregivers age is more than 18 years old
Able to understand Malay Language</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Primary caregivers with children who have been diagnosed with any chronic diseases.</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: </i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hygiene practice. Timepoint: 1 and 3 months post intervention. Method of measurement: a validated and pre-tested questionnaire by face-to-face interviews.</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>University Putra Malaysia</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-03</approval_date>
        <contact_name>Medical Research &amp; Ethics Committee (MREC)</contact_name>
        <contact_address>Institut Pengurusan Kesihatan, Jalan Rumah Sakit Kuala Lumpur Bangsar Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
