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/NCT05985876</url>
    </required_header>
    <id_info>
      <org_study_id>KULEA-NET</org_study_id>
      <secondary_id>1R44MD016829-01A1</secondary_id>
      <nct_id>NCT05985876</nct_id>
    </id_info>
    <brief_title>KULEA-NET: A Mobile Application for African American/Black Mothers to Promote Exclusive and Continuous Breastfeeding</brief_title>
    <acronym>KULEA-NET</acronym>
    <official_title>Knowledge and Usage of Lactation Using Education and Advice From Support Network (KULEA-NET)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Benten Technologies, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>George Washington University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Medstar Health Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Benten Technologies, Inc.</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>
        KULEA-NET is a mHealth intervention that will improve knowledge, self-efficacy, and&#xD;
        intentions related to exclusive breastfeeding (EBF). These factors have been demonstrated to&#xD;
        have a positive influence on breastfeeding (BF) initiation and duration among African&#xD;
        American/Black (AA/B) mothers. In the long term, KULEA-NET has great potential to achieve&#xD;
        increased BF initiation and EBF rates among AA/B mothers and as a result, improved maternal&#xD;
        and infant health outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Failure to initiate breastfeeding (BF) and exclusively breastfeed (EBF) for the recommended&#xD;
        6-month duration, can result in long-term morbidity among both mothers and their infants.&#xD;
        African Americans/Blacks (AA/B) have the lowest BF initiation and EBF rates among all racial&#xD;
        ethnicities in the US. AA/B infants have disproportionately high rates of mortality, and&#xD;
        children have a high incidence of asthma and sudden infant death syndrome (SIDS) while AA/B&#xD;
        mothers are at high risk for chronic illnesses like obesity, diabetes, and cardiovascular&#xD;
        diseases. These health disparities cost the US more than $9.1 billion in medical treatment&#xD;
        annually but can be reduced by increasing EBF rates. However, AA/B women experience barriers&#xD;
        on multiple levels to initiating, continuing BF, and maintaining EBF (either by discontinuing&#xD;
        BF or introducing supplements BF with other foods). With high rates of smartphone ownership&#xD;
        and consumption of digital content in AA/B women, the proposed mHealth intervention has great&#xD;
        potential to increase BF initiation and maintain EBF among AA/B women and has demonstrated&#xD;
        feasibility (user satisfaction and use) in our prior completed feasibility study. The&#xD;
        proposed SBIR Direct Phase II application, Knowledge and Usage of Lactation using Education&#xD;
        and Advice from Support Network (KULEA-NET) addresses an unmet need for an evidence-based&#xD;
        mobile app, providing comprehensive BF support and addresses the interrelated and complex BF&#xD;
        barriers AA/B mothers experience across the socio-ecological layers.&#xD;
  &#xD;
        KULEA-NET will provide comprehensive BF support to nurture and support AA/B women in BF&#xD;
        initiation and EBF, and include the following innovative features: a) Social marketing and&#xD;
        health branding to promote EBF as a socially desirable behavior; b) Micro-learning&#xD;
        educational content to improve the acquisition of knowledge and skills related to EBF; c)&#xD;
        Support network communication tools leveraging asynchronous communication that allow mothers&#xD;
        to communicate with her BF supporters, peers, and lactation professional supports; d)&#xD;
        Context-aware delivery framework that will capitalize on user information such as date of&#xD;
        delivery, feeding, and diaper log data, and location variables to provide timely feedback,&#xD;
        content, and guidance; and e) a Virtual community support network bringing together AA/B&#xD;
        mothers and their spouse/family members, and fostering a community of mutual support.&#xD;
  &#xD;
        The hypothesize of KULEA-NET is to improve knowledge, BF self-efficacy, and intentions to BF,&#xD;
        and ultimately achieve increased BF initiation, BF duration, and EBF rates at 6 months among&#xD;
        AA/B mothers and, as a result, improved maternal and infant health outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>African American/Black (AA/B) women recruited at 3 distinct stages of pregnancy - i.e. 1) 29 to 34 weeks gestational age, 2) 35 to 40 weeks gestational age, and 3)immediately post-partum, will be assigned to the intervention group and start using the KULEA-NET platform. Women in intervention arm #1 will use KULEA-NET for a total duration of approximately 9 months (3 months prenatal and 6 months post-partum; women in the intervention arm #2 will use KULEA-NET for a total duration of approximately 7 months (1 month prenatal and 6 months post-partum); and women in the intervention arm #3 will use KULEA-NET for a total duration of approximately 6 months (only post-partum). Each woman will have access to all components of the KULEA-NET platform: text messages, a knowledge base, 3 different types of videos, and breastfeeding-friendly spaces and breastfeeding classes near them.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of exclusive breastfeeding (EBF) rates</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>We will assess if participants are breastfeeding exclusively through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of any breastfeeding (BF) rates</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>We will assess if participants are breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of breastfeeding initiation rates</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>We will assess if participants are initiated breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF initiation at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change of breastfeeding attitudes</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>Iowa Infant Feeding Attitude Scale (IIFAS)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change of intention to breastfeed</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>Infant Feeding Intentions (IFI) Scale</description>
    </other_outcome>
    <other_outcome>
      <measure>Change of breastfeeding self-efficacy</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>BF Self-Efficacy Scale Short Form (BSES-SF)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change of perceived social support and social self-efficacy</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>Interpersonal Support Evaluation List (ISEL)</description>
    </other_outcome>
    <other_outcome>
      <measure>Usability</measure>
      <time_frame>Week 24 postpartum</time_frame>
      <description>System Usability Scale (SUS)survey will be used to assess usability of the KULEA-NET app</description>
    </other_outcome>
    <other_outcome>
      <measure>Engagement</measure>
      <time_frame>Week 24 postpartum</time_frame>
      <description>Brand Equity Scale to measure engagement with the app</description>
    </other_outcome>
    <other_outcome>
      <measure>Change of knowledge and beliefs about breastfeeding</measure>
      <time_frame>Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up</time_frame>
      <description>Custom survey, based in part on an instrument developed by Dr. Evans and colleagues to evaluate the KULEA-NET intervention (GWU IRB approval # 111047), will be used to collect self-reported knowledge and attitudes related to breastfeeding.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">523</enrollment>
    <condition>Breastfeeding</condition>
    <condition>Exclusive Breastfeeding</condition>
    <arm_group>
      <arm_group_label>KULEA-NET application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants using the KULEA-NET application in addition to the usual care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group: Usual Care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Control participants will receive usual care i.e. standard obstetrical care at MWHC and Mamatoto Village and will receive the standard Babyscripts app only without the KULEA-NET tile.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>KULEA-NET application</intervention_name>
      <description>African American/Black (AA/B) women recruited at 3 distinct stages of pregnancy - i.e. 1) 29 to 34 weeks gestational age, 2) 35 to 40 weeks gestational age, and 3)immediately post-partum, will be assigned to the intervention group and start using the KULEA-NET platform. Women in the intervention arm #1 will use KULEA-NET for a total duration of approximately 9 months (3 months prenatal and 6 months post-partum; women in the intervention arm #2 will use KULEA-NET for a total duration of approximately 7 months (1 month prenatal and 6 months post-partum); and women in the intervention arm #3 will use KULEA-NET for a total duration of approximately 6 months (only post-partum). Each woman will have access to all components of the KULEA-NET platform: the text messages, knowledge base, 3 different types of videos, and breastfeeding-friendly spaces and breastfeeding classes near them.</description>
      <arm_group_label>KULEA-NET application</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Control Group: Usual Care</intervention_name>
      <description>Control participants will receive usual care i.e. standard obstetrical care at MWHC and Mamatoto Village and will receive standard Babyscripts app only without the KULEA-NET tile. Information from the ACOG about the maternal and infant health benefits of breastfeeding will also be provided (e.g., they will get pamphlets on the importance of breastfeeding as well as lactation consultation).</description>
      <arm_group_label>Control Group: Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  African American/Black Ethnicity&#xD;
  &#xD;
            -  Speak and understand English,&#xD;
  &#xD;
            -  Between the ages of 18-44 years,&#xD;
  &#xD;
            -  Intention to continue BF after discharge from the hospital&#xD;
  &#xD;
            -  Willingly provide written informed consent&#xD;
  &#xD;
            -  Own a smartphone (either iOS or Android)&#xD;
  &#xD;
            -  Have access to the internet through their smartphone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  An infant born with cleft lip/palate, congenital heart defects, Down Syndrome, neural&#xD;
               tube defects, or other conditions that require admission to a NICU or interfere with&#xD;
               BF&#xD;
  &#xD;
            -  Human immunodeficiency virus (HIV)&#xD;
  &#xD;
            -  Taking antiretroviral medication or chemotherapy agents&#xD;
  &#xD;
            -  Untreated, active tuberculosis&#xD;
  &#xD;
            -  T-Cell lymphotropic virus type I or type II&#xD;
  &#xD;
            -  Illicit drug use&#xD;
  &#xD;
            -  Receiving radiation therapy&#xD;
  &#xD;
            -  Exposed to anthrax&#xD;
  &#xD;
            -  Undergone breast surgery&#xD;
  &#xD;
            -  Active hepatitis B or C&#xD;
  &#xD;
            -  Any prescription drug use incompatible with lactation&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The proposed study seeks to enroll approximately pregnant or post-partum African American/Black (AA/B) women. Given the focus of the proposed research, we will only recruit women.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>44 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tony Ma, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Benten Technologies</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Doug Evans, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>George Washington University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Loral Patchen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medstar Research Health Institute</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mamatoto Village</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20019-3739</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The George Washington University</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20052-0042</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Medstar Health Research Institute</name>
        <address>
          <city>Hyattsville</city>
          <state>Maryland</state>
          <zip>20782</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Benten Technologies, Inc.</investigator_affiliation>
      <investigator_full_name>Tony Ma</investigator_full_name>
      <investigator_title>Project Director or Principal Investigator</investigator_title>
    </responsible_party>
    <!-- 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/NCT05985876
  org study id: KULEA-NET
  secondary id: 1R44MD016829-01A1
  nct id: NCT05985876
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  KULEA-NET is a mHealth intervention that will improve knowledge, self-efficacy, and
        intentions related to exclusive breastfeeding (EBF). These factors have been demonstrated to
        have a positive influence on breastfeeding (BF) initiation and duration among African
        American/Black (AA/B) mothers. In the long term, KULEA-NET has great potential to achieve
        increased BF initiation and EBF rates among AA/B mothers and as a result, improved maternal
        and infant health outcomes.
  Failure to initiate breastfeeding (BF) and exclusively breastfeed (EBF) for the recommended
        6-month duration, can result in long-term morbidity among both mothers and their infants.
        African Americans/Blacks (AA/B) have the lowest BF initiation and EBF rates among all racial
        ethnicities in the US. AA/B infants have disproportionately high rates of mortality, and
        children have a high incidence of asthma and sudden infant death syndrome (SIDS) while AA/B
        mothers are at high risk for chronic illnesses like obesity, diabetes, and cardiovascular
        diseases. These health disparities cost the US more than $9.1 billion in medical treatment
        annually but can be reduced by increasing EBF rates. However, AA/B women experience barriers
        on multiple levels to initiating, continuing BF, and maintaining EBF (either by discontinuing
        BF or introducing supplements BF with other foods). With high rates of smartphone ownership
        and consumption of digital content in AA/B women, the proposed mHealth intervention has great
        potential to increase BF initiation and maintain EBF among AA/B women and has demonstrated
        feasibility (user satisfaction and use) in our prior completed feasibility study. The
        proposed SBIR Direct Phase II application, Knowledge and Usage of Lactation using Education
        and Advice from Support Network (KULEA-NET) addresses an unmet need for an evidence-based
        mobile app, providing comprehensive BF support and addresses the interrelated and complex BF
        barriers AA/B mothers experience across the socio-ecological layers.
  
        KULEA-NET will provide comprehensive BF support to nurture and support AA/B women in BF
        initiation and EBF, and include the following innovative features: a) Social marketing and
        health branding to promote EBF as a socially desirable behavior; b) Micro-learning
        educational content to improve the acquisition of knowledge and skills related to EBF; c)
        Support network communication tools leveraging asynchronous communication that allow mothers
        to communicate with her BF supporters, peers, and lactation professional supports; d)
        Context-aware delivery framework that will capitalize on user information such as date of
        delivery, feeding, and diaper log data, and location variables to provide timely feedback,
        content, and guidance; and e) a Virtual community support network bringing together AA/B
        mothers and their spouse/family members, and fostering a community of mutual support.
  
        The hypothesize of KULEA-NET is to improve knowledge, BF self-efficacy, and intentions to BF,
        and ultimately achieve increased BF initiation, BF duration, and EBF rates at 6 months among
        AA/B mothers and, as a result, improved maternal and infant health outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: African American/Black (AA/B) women recruited at 3 distinct stages of pregnancy - i.e. 1) 29 to 34 weeks gestational age, 2) 35 to 40 weeks gestational age, and 3)immediately post-partum, will be assigned to the intervention group and start using the KULEA-NET platform. Women in intervention arm #1 will use KULEA-NET for a total duration of approximately 9 months (3 months prenatal and 6 months post-partum; women in the intervention arm #2 will use KULEA-NET for a total duration of approximately 7 months (1 month prenatal and 6 months post-partum); and women in the intervention arm #3 will use KULEA-NET for a total duration of approximately 6 months (only post-partum). Each woman will have access to all components of the KULEA-NET platform: text messages, a knowledge base, 3 different types of videos, and breastfeeding-friendly spaces and breastfeeding classes near them.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change of exclusive breastfeeding (EBF) rates
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: We will assess if participants are breastfeeding exclusively through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3.
  measure: Change of any breastfeeding (BF) rates
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: We will assess if participants are breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3.
  measure: Change of breastfeeding initiation rates
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: We will assess if participants are initiated breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF initiation at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm.
  measure: Change of breastfeeding attitudes
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: Iowa Infant Feeding Attitude Scale (IIFAS)
  measure: Change of intention to breastfeed
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: Infant Feeding Intentions (IFI) Scale
  measure: Change of breastfeeding self-efficacy
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: BF Self-Efficacy Scale Short Form (BSES-SF)
  measure: Change of perceived social support and social self-efficacy
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: Interpersonal Support Evaluation List (ISEL)
  measure: Usability
  time frame: Week 24 postpartum
  description: System Usability Scale (SUS)survey will be used to assess usability of the KULEA-NET app
  measure: Engagement
  time frame: Week 24 postpartum
  description: Brand Equity Scale to measure engagement with the app
  measure: Change of knowledge and beliefs about breastfeeding
  time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
  description: Custom survey, based in part on an instrument developed by Dr. Evans and colleagues to evaluate the KULEA-NET intervention (GWU IRB approval # 111047), will be used to collect self-reported knowledge and attitudes related to breastfeeding.
  arm group label: KULEA-NET application
  arm group type: Experimental
  description: Participants using the KULEA-NET application in addition to the usual care
  arm group label: Control Group: Usual Care
  arm group type: Experimental
  description: Control participants will receive usual care i.e. standard obstetrical care at MWHC and Mamatoto Village and will receive the standard Babyscripts app only without the KULEA-NET tile.
  intervention type: Behavioral
  intervention name: KULEA-NET application
  description: African American/Black (AA/B) women recruited at 3 distinct stages of pregnancy - i.e. 1) 29 to 34 weeks gestational age, 2) 35 to 40 weeks gestational age, and 3)immediately post-partum, will be assigned to the intervention group and start using the KULEA-NET platform. Women in the intervention arm #1 will use KULEA-NET for a total duration of approximately 9 months (3 months prenatal and 6 months post-partum; women in the intervention arm #2 will use KULEA-NET for a total duration of approximately 7 months (1 month prenatal and 6 months post-partum); and women in the intervention arm #3 will use KULEA-NET for a total duration of approximately 6 months (only post-partum). Each woman will have access to all components of the KULEA-NET platform: the text messages, knowledge base, 3 different types of videos, and breastfeeding-friendly spaces and breastfeeding classes near them.
  arm group label: KULEA-NET application
  intervention type: Behavioral
  intervention name: Control Group: Usual Care
  description: Control participants will receive usual care i.e. standard obstetrical care at MWHC and Mamatoto Village and will receive standard Babyscripts app only without the KULEA-NET tile. Information from the ACOG about the maternal and infant health benefits of breastfeeding will also be provided (e.g., they will get pamphlets on the importance of breastfeeding as well as lactation consultation).
  arm group label: Control Group: Usual Care
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The proposed study seeks to enroll approximately pregnant or post-partum African American/Black (AA/B) women. Given the focus of the proposed research, we will only recruit women.
  minimum age: 18 Years
  maximum age: 44 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tony Ma, MS
  role: Principal Investigator
  affiliation: Benten Technologies
  last name: Doug Evans, PhD
  role: Principal Investigator
  affiliation: George Washington University
  last name: Loral Patchen, PhD
  role: Principal Investigator
  affiliation: Medstar Research Health Institute
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Benten Technologies, Inc.
  investigator full name: Tony Ma
  investigator title: Project Director or Principal Investigator