<?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>IRCT20220415054539N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-04</date_registration>
      <primary_sponsor>Universiti Teknologi MARA</primary_sponsor>
      <public_title>The Effects of WhaSTOP mHealth Intervention on Stages on Change of Smoking Behaviour among Workers</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of WhaSTOP mHealth Intervention on Stages on Change of Smoking Behaviour among Workers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63090</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Quasi-experimental.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Smoker in precontemplation and contemplation stages.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will received WhaSTOP module and usual care (quit smoking pamphlet). The module consists of 14 educational and motivational videos on smoking behavior and cessation. Three to four videos will be delivered to the participants via Whatsapp every week for 4 weeks. Intervention 2: Control group will received usual care (quit smoking pamphlet) during recruitment.</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>Syaharatul Patimah Kamarudin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Universiti Teknologi MARA, Fakulti Perubatan Kampus Sungai Buloh, Jalan Hospital, 47000 Sungai Buloh, Selangor</address>
        <city>Sungai Buloh</city>
        <country1>Malaysia</country1>
        <zip>47000</zip>
        <telephone>+60 3-6126 5000</telephone>
        <email>2020631502@student.uitm.edu.my</email>
        <affiliation>Universiti Teknologi MARA</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Syaharatul Patimah Kamarudin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Universiti Teknologi MARA, Fakulti Perubatan Kampus Sungai Buloh, Jalan Hospital, 47000 Sungai Buloh, Selangor</address>
        <city>Sungai Buloh</city>
        <country1>Malaysia</country1>
        <zip>47000</zip>
        <telephone>+60 3-6126 5000</telephone>
        <email>2020631502@student.uitm.edu.my</email>
        <affiliation>Universiti Teknologi MARA</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
      <country2>Malaysia</country2>
      <country2>Malaysia</country2>
      <country2>Malaysia</country2>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Smoker among workers
Aged 18 years or above
Being in the stages of precontemplation or contemplation based on the Transtheoretical Model Stage of Change, but are willing to take action to promote health
Having a smartphone and being able to use WhatsApp for communication at least four days per week
Willing to receive and commit to reading WhaSTOP intervention throughout the study period
Able to understand and read in the Malay language</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participation in other smoking cessation programmes or services
On extended leave during the study period
Those who unable to give informed consent or participate in the study due to impaired mental status, cognitive impairment, or communication barrier</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>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group will received WhaSTOP module and usual care (quit smoking pamphlet). The module consists of 14 educational and motivational videos on smoking behavior and cessation. Three to four videos will be delivered to the participants via Whatsapp every week for 4 weeks.</i_keyword>
      <i_keyword>Control group will received usual care (quit smoking pamphlet) during recruitment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stage movement. Timepoint: Baseline (before intervention) and 4 and 8 weeks after intervention. Method of measurement: TTM constructs questionnaire - stages of change.</prim_outcome>
      <prim_outcome>Number of cigarettes smoked per day. Timepoint: Baseline (before intervention) and 2, 4, 6 and 8 weeks after intervention. Method of measurement: Self-reported measure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge of smoking. Timepoint: Baseline (before intervention) and 4 and 8 weeks after intervention. Method of measurement: Global Adult Tobacco Survey (GATS) questionnaire.</sec_outcome>
      <sec_outcome>Quit attempt. Timepoint: Baseline (before intervention) and 4 and 8 weeks after intervention. Method of measurement: Self-reported measure.</sec_outcome>
      <sec_outcome>Smoking abstinence. Timepoint: Baseline (before intervention) and 4 and 8 weeks after intervention. Method of measurement: Self-reported measure.</sec_outcome>
      <sec_outcome>Nicotine dependence level. Timepoint: Baseline (before intervention) and 4 and 8 weeks after intervention. Method of measurement: Fagerstrom Test of Nicotine Dependence Questionnaire.</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>Universiti Teknologi MARA</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-11</approval_date>
        <contact_name>The Research Ethics Committee Universiti Teknologi Mara</contact_name>
        <contact_address>UiTM Research Ethics Committee,  Office of Deputy Vice Chancellor (Research and Innovation),   Level 3 Bangunan Wawasan Shah Alam Selangor Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
