<?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>IRCT20220320054334N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-17</date_registration>
      <primary_sponsor>University of Muhammadiyah Surakarta</primary_sponsor>
      <public_title>Effect of mHealth intervention in preventing pregnancy anemia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of using ANEDOC APP and daily educative message reminder in knowledge,  consumption of anemia prevention diet and Fe Supplement, and hemoglobin level on pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62620</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of randomization is block randomization. Unit of randomization is individual. Tools used in randomization is web-based software. A combination of 4 in 1 block and 2 in 1 block is used to built the sequence. The allocation concealment was not carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anemia in pregnant women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: ANEDOC APP intervention. Respondents are guided to install ANEDOP APP on their mobile phones. They will be given instructions to fill in the data needed to run the application and activated the education and reminder feature of the ANEDOC APP. They will be monitored using this application through the WhatsApp Group. The duration of the intervention was 6 weeks. Intervention 2: Intervention group 2: Daily messages reminder. Respondents will receive daily educational and reminder messages through WhatsApp. The short message delivered in visual graphics consists of two sentences.  The first sentence contains educational content about the symptoms, impacts, and prevention of anemia. The last sentence is a persuasion message to do the anemia prevention behaviors. There will be 21 different messages that will be sent twice in 6 weeks period. Intervention 3: Control group: The control group will receive standard Antenatal Care from the Primary Health Care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Izzatul Arifah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1. Tromol Pos Street. Gonilan, Surakarta city</address>
        <city>Surakarta</city>
        <country1>Indonesia</country1>
        <zip>57102</zip>
        <telephone>+62 271 717417</telephone>
        <email>izzatul.arifah@ums.ac.id</email>
        <affiliation>University of Muhammadiyah Surakarta</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Izzatul Arifah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1. Tromol Pos Street. Gonilan, Surakarta city</address>
        <city>Surakarta</city>
        <country1>Indonesia</country1>
        <zip>57102</zip>
        <telephone>+62 271 717417</telephone>
        <email>izzatul.arifah@ums.ac.id</email>
        <affiliation>University of Muhammadiyah Surakarta</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Indonesia</country2>
      <country2>Indonesia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women with 18-30 weeks gestational age at the time of the study
Pregnant woman who did the Antenatal Care at the Sangkrah and Kratonan Health Center (Puskesmas) in Surakarta Regency, Central Java, Indonesia
Had an android based smartphone
Active WhatsApp users
willing to be research respondents</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>had serious gestational complications such as hypertension, preeclampsia, and cardiovascular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iron deficiency anemia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: ANEDOC APP intervention. Respondents are guided to install ANEDOP APP on their mobile phones. They will be given instructions to fill in the data needed to run the application and activated the education and reminder feature of the ANEDOC APP. They will be monitored using this application through the WhatsApp Group. The duration of the intervention was 6 weeks.</i_keyword>
      <i_keyword>Intervention group 2: Daily messages reminder. Respondents will receive daily educational and reminder messages through WhatsApp. The short message delivered in visual graphics consists of two sentences.  The first sentence contains educational content about the symptoms, impacts, and prevention of anemia. The last sentence is a persuasion message to do the anemia prevention behaviors. There will be 21 different messages that will be sent twice in 6 weeks period.</i_keyword>
      <i_keyword>Control group: The control group will receive standard Antenatal Care from the Primary Health Care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge, consumption of anemia prevention diet and Fe supplement. Timepoint: Before intervention and 1 week after intervention. Method of measurement: Measuring knowledge, consumption of anemia prevention diet, and Fe supplement using questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemoglobin level. Timepoint: Before intervention and 1 weeks after intervention. Method of measurement: Measuring the hemoglobin level using Sahli's Haemoglobinometer.</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 of Muhammadiyah Surakarta</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-05</approval_date>
        <contact_name>Ethics committee of Faculty of Medicine, University of Muhammadiyah Surakarta</contact_name>
        <contact_address>No. 1 Pos Tromol street, Gonilan, Surakarta city. Faculty of Medicine, University of Muhammadiyah Surakarta Surakarta Central Java Indonesia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
