xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05979571</url>
    </required_header>
    <id_info>
      <org_study_id>2880</org_study_id>
      <nct_id>NCT05979571</nct_id>
    </id_info>
    <brief_title>Developing and Testing an Educational Intervention Through Technological Platform to Support Exclusive Breastfeeding</brief_title>
    <official_title>Development of Educational Intervention Through Technological Platform to Support Exclusive Breastfeeding up to Six Months Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pacifica Salud Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sistema Nacional de Investigación Senacyt Panamá</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Pacifica Salud Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Although breastfeeding provides the infant with all the nutrients necessary for its&#xD;
        development, it has been observed that in Panama there are low rates of Exclusive&#xD;
        Breastfeeding. Educational interventions, that support exclusive breastfeeding, which begin&#xD;
        before delivery and continue to the postnatal period, have been shown to be effective.&#xD;
  &#xD;
        The main objective of the study is the development and testing of an educational intervention&#xD;
        through web based platform, to support exclusive breastfeeding up to 6 months. This&#xD;
        educational intervention will provide guidance with the help of an audiovisual format, with&#xD;
        information and breastfeeding techniques, which mothers can reproduce as many times as&#xD;
        necessary.&#xD;
  &#xD;
        The main objective of the study is the development and testing of an educational intervention&#xD;
        through AmiHealth, to support exclusive breastfeeding up to 6 months.&#xD;
  &#xD;
        A pilot study will be conducted on a non-random convenience sample.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The team leveraged a user-centered design (UCD) approach to design and develop the initial&#xD;
        version of the breastfeeding app. An agile development methodology for content and technology&#xD;
        development which integrates feedback from all key stakeholders in the development process to&#xD;
        refine the app over time, including the content and app.In parallel with the app design, the&#xD;
        educational content for the intervention was developed with experts in the field.&#xD;
  &#xD;
        The contents that will be develop for the breastfeeding module, Data operating system will be&#xD;
        used for data management and analytical and projection tools.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mobile application rating scale (MARS)</measure>
      <time_frame>two weeks</time_frame>
      <description>The quality of the apps will be asses using MARS. This methodology includes 23 evaluation criteria, clustered within 5 domains: (1) &quot;Engagement,&quot; which assesses the entertainment, customization, and interactivity of the app (feedback, reminders, and notifications); (2) &quot;Functionality,&quot; which examines the functionality of the app, ease of use, transition between screens, and intuitive design; (3) &quot;Esthetics,&quot; which assesses graphic design, visual appeal, and stylistic consistency; (4) &quot;Information,&quot; which evaluates the quality of the content (text, measures, and references), determined by the credibility of the source; and (5) &quot;Subjective quality,&quot; which determines whether the app could be recommended to people who might benefit from it, if they would be prepared to pay for it, how many times it would be used, and what overall star rating it would be given. Each evaluation criterion was rated from 1 to 5 (1=Inadequate, 2=Poor, 3=Acceptable, 4=Good, 5=Excellent)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Breastfeeding, Exclusive</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mobile health app</intervention_name>
      <description>Breastfeeding knowledge and promotion information will be delivered through the AmiBreastfeed app platform</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. First pregnancy&#xD;
  &#xD;
            2. Third trimester&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  twin pregnancies fetal defects or newborns with malformations&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tania T Herrera, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pacifica Salud Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Isabel Blanco, MD</last_name>
      <phone>2048000</phone>
      <phone_ext>8751</phone_ext>
      <email>iblanco@pacificasalud.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Idalina Cubilla, PhD</last_name>
      <phone>2048000</phone>
      <phone_ext>8751</phone_ext>
      <email>idacubilla@gmail.com</email>
    </overall_contact_backup>
    <link>
      <url>https://www.unicef.org/media/48046/file/UNICEF_Breastfeeding_A_Mothers_Gift_for_Every_Child.pdf</url>
      <description>Unicef Breastfeeding Information</description>
    </link>
    <link>
      <url>https://panama.unfpa.org/sites/default/files/pub-pdf/ENASSER-2014-2015-WEB.pdf</url>
      <description>Sexual and Reproductive Health survey 2014-2015</description>
    </link>
    <results_reference>
      <citation>Meedya S, Fernandez R, Fahy K. Effect of educational and support interventions on long-term breastfeeding rates in primiparous women: a systematic review and meta-analysis. JBI Database System Rev Implement Rep. 2017 Sep;15(9):2307-2332. doi: 10.11124/JBISRIR-2016-002955.</citation>
      <PMID>28902698</PMID>
    </results_reference>
    <results_reference>
      <citation>Spatz DL, Davanzo R, Muller JA, Powell R, Rigourd V, Yates A, Geddes DT, van Goudoever JB, Bode L. Promoting and Protecting Human Milk and Breastfeeding in a COVID-19 World. Front Pediatr. 2021 Feb 3;8:633700. doi: 10.3389/fped.2020.633700. eCollection 2020.</citation>
      <PMID>33614547</PMID>
    </results_reference>
    <results_reference>
      <citation>Vu Hoang D, Cashin J, Gribble K, Marinelli K, Mathisen R. Misalignment of global COVID-19 breastfeeding and newborn care guidelines with World Health Organization recommendations. BMJ Nutr Prev Health. 2020 Dec 22;3(2):339-350. doi: 10.1136/bmjnph-2020-000184. eCollection 2020 Dec.</citation>
      <PMID>33521544</PMID>
    </results_reference>
    <results_reference>
      <citation>Huang MZ, Kuo SC, Avery MD, Chen W, Lin KC, Gau ML. Evaluating effects of a prenatal web-based breastfeeding education programme in Taiwan. J Clin Nurs. 2007 Aug;16(8):1571-9. doi: 10.1111/j.1365-2702.2006.01843.x.</citation>
      <PMID>17655546</PMID>
    </results_reference>
    <results_reference>
      <citation>Alberdi G, O'Sullivan EJ, Scully H, Kelly N, Kincaid R, Murtagh R, Murray S, McGuinness D, Clive A, Brosnan M, Sheehy L, Dunn E, McAuliffe FM. A feasibility study of a multidimensional breastfeeding-support intervention in Ireland. Midwifery. 2018 Mar;58:86-92. doi: 10.1016/j.midw.2017.12.018. Epub 2017 Dec 24.</citation>
      <PMID>29324318</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>breastfeeding, mobile health, perinatal care, primary care</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05979571
  org study id: 2880
  nct id: NCT05979571
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Although breastfeeding provides the infant with all the nutrients necessary for its
        development, it has been observed that in Panama there are low rates of Exclusive
        Breastfeeding. Educational interventions, that support exclusive breastfeeding, which begin
        before delivery and continue to the postnatal period, have been shown to be effective.
  
        The main objective of the study is the development and testing of an educational intervention
        through web based platform, to support exclusive breastfeeding up to 6 months. This
        educational intervention will provide guidance with the help of an audiovisual format, with
        information and breastfeeding techniques, which mothers can reproduce as many times as
        necessary.
  
        The main objective of the study is the development and testing of an educational intervention
        through AmiHealth, to support exclusive breastfeeding up to 6 months.
  
        A pilot study will be conducted on a non-random convenience sample.
  The team leveraged a user-centered design (UCD) approach to design and develop the initial
        version of the breastfeeding app. An agile development methodology for content and technology
        development which integrates feedback from all key stakeholders in the development process to
        refine the app over time, including the content and app.In parallel with the app design, the
        educational content for the intervention was developed with experts in the field.
  
        The contents that will be develop for the breastfeeding module, Data operating system will be
        used for data management and analytical and projection tools.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Mobile application rating scale (MARS)
  time frame: two weeks
  description: The quality of the apps will be asses using MARS. This methodology includes 23 evaluation criteria, clustered within 5 domains: (1) "Engagement," which assesses the entertainment, customization, and interactivity of the app (feedback, reminders, and notifications); (2) "Functionality," which examines the functionality of the app, ease of use, transition between screens, and intuitive design; (3) "Esthetics," which assesses graphic design, visual appeal, and stylistic consistency; (4) "Information," which evaluates the quality of the content (text, measures, and references), determined by the credibility of the source; and (5) "Subjective quality," which determines whether the app could be recommended to people who might benefit from it, if they would be prepared to pay for it, how many times it would be used, and what overall star rating it would be given. Each evaluation criterion was rated from 1 to 5 (1=Inadequate, 2=Poor, 3=Acceptable, 4=Good, 5=Excellent)
  arm group label: Experimental
  arm group type: Experimental
  intervention type: Other
  intervention name: Mobile health app
  description: Breastfeeding knowledge and promotion information will be delivered through the AmiBreastfeed app platform
  arm group label: Experimental
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Tania T Herrera, MD
  role: Principal Investigator
  affiliation: Pacifica Salud Hospital
  last name: Isabel Blanco, MD
  phone: 2048000
  phone ext: 8751
  email: iblanco@pacificasalud.com
  last name: Idalina Cubilla, PhD
  phone: 2048000
  phone ext: 8751
  email: idacubilla@gmail.com
  url: https://www.unicef.org/media/48046/file/UNICEF_Breastfeeding_A_Mothers_Gift_for_Every_Child.pdf
  description: Unicef Breastfeeding Information
  url: https://panama.unfpa.org/sites/default/files/pub-pdf/ENASSER-2014-2015-WEB.pdf
  description: Sexual and Reproductive Health survey 2014-2015
  citation: Meedya S, Fernandez R, Fahy K. Effect of educational and support interventions on long-term breastfeeding rates in primiparous women: a systematic review and meta-analysis. JBI Database System Rev Implement Rep. 2017 Sep;15(9):2307-2332. doi: 10.11124/JBISRIR-2016-002955.
  PMID: 28902698
  citation: Spatz DL, Davanzo R, Muller JA, Powell R, Rigourd V, Yates A, Geddes DT, van Goudoever JB, Bode L. Promoting and Protecting Human Milk and Breastfeeding in a COVID-19 World. Front Pediatr. 2021 Feb 3;8:633700. doi: 10.3389/fped.2020.633700. eCollection 2020.
  PMID: 33614547
  citation: Vu Hoang D, Cashin J, Gribble K, Marinelli K, Mathisen R. Misalignment of global COVID-19 breastfeeding and newborn care guidelines with World Health Organization recommendations. BMJ Nutr Prev Health. 2020 Dec 22;3(2):339-350. doi: 10.1136/bmjnph-2020-000184. eCollection 2020 Dec.
  PMID: 33521544
  citation: Huang MZ, Kuo SC, Avery MD, Chen W, Lin KC, Gau ML. Evaluating effects of a prenatal web-based breastfeeding education programme in Taiwan. J Clin Nurs. 2007 Aug;16(8):1571-9. doi: 10.1111/j.1365-2702.2006.01843.x.
  PMID: 17655546
  citation: Alberdi G, O'Sullivan EJ, Scully H, Kelly N, Kincaid R, Murtagh R, Murray S, McGuinness D, Clive A, Brosnan M, Sheehy L, Dunn E, McAuliffe FM. A feasibility study of a multidimensional breastfeeding-support intervention in Ireland. Midwifery. 2018 Mar;58:86-92. doi: 10.1016/j.midw.2017.12.018. Epub 2017 Dec 24.
  PMID: 29324318
  responsible party type: Sponsor
  sharing ipd: No