<?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>IRCT20190705044103N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-25</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>An educational intervention based on a mobile phone application for improving maternal breastfeeding of infants in their first six month of life in Urmia, Iran.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of a smartphone based, educational intervention on breastfeeding self-efficacy and mothers’ health literacy with infants in their first six month of life in Urmia, Iran.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46866</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random Allocation Software 1.0 (https://random-allocation software.software.informer.com/1.0/) was utilized to allocate the mother and child pair to intervention or control groups in a 1:1 ratio.
The permuted block method of randomization for a block size of four was used. Based on the limited size of the trial, this procedure was preferred to simple randomization in order to maintain an adequate balance in the number of participants allocated to each of the study groups, Blinding description: For avoiding the bias in this study, the control and intervention group were not accessible to each other. So the participants were recruited separately in an isolated room.
Data collectors and care providers were blinded to group assignment and they just investigated the inclusion criteria in the defined clinic.
The randomization was performed by a researcher with no access to participant information and who did not participate in the enrollment process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Child growth and development.</hc_freetext>
      <i_freetext>Intervention 1: Android compatible application was developed then tested and trialed through one week with cooperating test group consists of technical experts and some usual users.The designed application is for educating mothers about the required knowledge for breastfeeding. In accordance with the Ministry of Health and Maternity Guidelines for maternal and child health in the form of a comprehensive integrated healthy child care guide have been compiled in a list of things to be taught to mothers and used in the form of an educational content in the application.In the intervention arm, mothers were distributed this application installed on their phones which was featured by a topic-oriented educational manner to facilitate discovering the solution of encountered problems through lactating process. The intervention generally was scheduled for 3 month period. The mothers were followed-up and encouraged in using the app by calling them during the intervention. Intervention 2: Control group: In the control group, mother and child pairs were visited in the health center by a routine health service. The babies were vaccinated and assessed on developmental aspects based on weight, height and screening tests to determine the child abilities.</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:
Results will be presented in an article to be published in a leading scientific journal during 2021

When:
Intention to publish date 1/1/2021

To whom:
All researchers

Conditions:
Results will be presented in an article to be published in a leading scientific journal during 2021 so after publishing the data could be used

Where to obtain:
Results will be presented in an article to be published in a leading scientific journal during 2021 and the applicant could use the researchers email to communicate bahlol.rahimi@gmail.com

How to obtain:
Results will be presented in an article to be published in a leading scientific journal during 2021 and the applicant could use the researchers email to communicate bahlol.rahimi@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahlol Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nazloo Campus, Sero Road</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>571478334</zip>
        <telephone>+98 44 3345 0459</telephone>
        <email>bahlol.rahimi@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahlol Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nazloo Campus, Sero Road</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>571478334</zip>
        <telephone>+98 44 3345 0459</telephone>
        <email>bahlol.rahimi@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>New mothers experiencing their firstborn child
Infants with less than three month of age</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>38 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If they were not in possession of a smart phone
Having a medical disorder requiring treatment</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>Android compatible application was developed then tested and trialed through one week with cooperating test group consists of technical experts and some usual users.The designed application is for educating mothers about the required knowledge for breastfeeding. In accordance with the Ministry of Health and Maternity Guidelines for maternal and child health in the form of a comprehensive integrated healthy child care guide have been compiled in a list of things to be taught to mothers and used in the form of an educational content in the application.In the intervention arm, mothers were distributed this application installed on their phones which was featured by a topic-oriented educational manner to facilitate discovering the solution of encountered problems through lactating process. The intervention generally was scheduled for 3 month period. The mothers were followed-up and encouraged in using the app by calling them during the intervention.</i_keyword>
      <i_keyword>Control group: In the control group, mother and child pairs were visited in the health center by a routine health service. The babies were vaccinated and assessed on developmental aspects based on weight, height and screening tests to determine the child abilities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal breastfeeding self-efficacy. Timepoint: Before intervention and three months after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>KAP (Knowledge, Attitude, Practice). Timepoint: Before intervention and three months after intervention. Method of measurement: Questionnaire.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-07</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Science</contact_name>
        <contact_address>Urmia University of Medical Sciences, Nazloo Campus, Sero Road Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
