<?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>IRCT2015010620591N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-05</date_registration>
      <primary_sponsor>Postgraduate Research Fund, University of Malaya</primary_sponsor>
      <public_title>The Healthy Worker Programme</public_title>
      <acronym></acronym>
      <scientific_title>The "Healthy Worker" Programme to Improve Dietary Intake, Physical Activity and Quality of Working Life among Klang Valley Office Workers: a quasi-experimental study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>256</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18235</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: quasi-experimental.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Controls: Health talks, pamphlets. Intervention 2: Intervention:Healthy Worker Programme: physical activity &amp; healthy diet intervention, health poster displays, healthy food at cafeteria, prize-giving for weight loss and increased steps per day, monthly motivation through office mail, telephone counselling.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Nur Suffia Sulaiman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalan Pahang</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip></zip>
        <telephone>0060326162733</telephone>
        <email>nursuffia@imr.gov.my</email>
        <affiliation>Institute for Medical Research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Nur Suffia Sulaiman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalan Pahang</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip></zip>
        <telephone>0060326162733</telephone>
        <email>nursuffia@imr.gov.my</email>
        <affiliation>Institute for Medical Research</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Employees with a body mass index of ≥23.0 kg/m2 will be invited to participate in the study. &#13;
Exclusion criteria: pregnancy, medical conditions which precludes moderate exercise and affects walking (eg. severe osteoarthritis of the knee, unstable angina, uncontrolled very high blood pressure, acute injury to lower limbs), cease to work at study site and unwilling to participate.</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>58 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Controls: Health talks, pamphlets</i_keyword>
      <i_keyword>Intervention:Healthy Worker Programme: physical activity &amp; healthy diet intervention, health poster displays, healthy food at cafeteria, prize-giving for weight loss and increased steps per day, monthly motivation through office mail, telephone counselling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: baseline, 3rd,6th and 9th month. Method of measurement: digital weighing scale (kilograms).</prim_outcome>
      <prim_outcome>Body mass index (used for sample calculation). Timepoint: baseline, 3rd,6th and 9th month. Method of measurement: weighing scale and stadiometer (kg/m2).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical activity. Timepoint: baseline, 3rd,6th and 9th month. Method of measurement: pedometer (steps/day) &amp; International Physical Activity Questionnaire (MET-mins/week).</sec_outcome>
      <sec_outcome>Dietary intake. Timepoint: baseline, 6th and 9th month. Method of measurement: calorie analysis, macro- and micronutrient dietary analysis.</sec_outcome>
      <sec_outcome>Quality of working life. Timepoint: baseline, 3rd,6th and 9th month. Method of measurement: Malay validated Work-Related Quality of Life Scale-2.</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>Postgraduate Research Fund, University of Malaya</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-29</approval_date>
        <contact_name>Medical Ethics Committee of University Malaya Medical Centre, Kuala Lumpur</contact_name>
        <contact_address>University Malaya Medical Centre Kuala Lumpur Wilayah Persekutuan Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
