<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/NCT03036696</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601909</org_study_id>
    <nct_id>NCT03036696</nct_id>
  </id_info>
  <brief_title>The BEACH Interview Study- Pregnant and Breastfeeding Mothers</brief_title>
  <acronym>BEACH</acronym>
  <official_title>The Breastfeeding and Early Child Health (BEACH) Interview Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</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>
      Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize;&#xD;
      clinical study recruitment and retention, patient-centered outcomes, and stool collection&#xD;
      procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an interview study that will enroll mothers during 28 weeks or greater of pregnancy&#xD;
      and assess recruitment, patient-centered outcomes, and stool collection procedures via&#xD;
      individualized interviews and data collection. Participants will be recruited from the&#xD;
      greater Gainesville, FL area. Data collection will include questionnaires/surveys as well as&#xD;
      minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab,&#xD;
      and urine collection. Participants will be seen at a location convenient for them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">August 9, 2019</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.</measure>
    <time_frame>6 months</time_frame>
    <description>Interviews will be analyzed to determine the efficacy of common strategies used to recruit pregnant and breastfeeding mothers into CRTs, challenges or barriers that would preclude women from enrolling and participating in CRTs, their preferences for incentives, as well their preference and methods related to non-invasive sample collection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Pediatric Obesity</condition>
  <condition>Recruitment</condition>
  <arm_group>
    <arm_group_label>Pregnant Mothers Interview</arm_group_label>
    <description>(1) 18 years old or over, (2) between 28-38 weeks of pregnancy, (3) lives in Gainesville, Florida, and (4) are committed to exclusively breastfeeding through 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breastfeeding Mothers Interview</arm_group_label>
    <description>(1) 18 years old or over, (2) actively breastfeeding infant less than 12 months of age, and (3) lives in Gainesville, Florida.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pregnant Mothers Interview</intervention_name>
    <description>Pregnant mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection and preferences for methods related to non-invasive sample collection.&#xD;
Data collection for pregnant mothers includes Clinical Health Update (3rd trimester) and Physical Activity questionnaires.&#xD;
The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.</description>
    <arm_group_label>Pregnant Mothers Interview</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breastfeeding Mothers Interview</intervention_name>
    <description>Breastfeeding mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection, and preferences for methods related to non-invasive sample collection.&#xD;
Data collection for breastfeeding mothers includes Clinical Health update (post-natal), Infant Feeding, and Physical Activity questionnaires.&#xD;
The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.</description>
    <arm_group_label>Breastfeeding Mothers Interview</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Non-invasive biospecimens include stool, saliva, blood, urine, human milk, and vaginal swab.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The research team will recruit pregnant women (n = 30) and breastfeeding mothers' (n = 30)&#xD;
        paired with infant (n=30) to participate in individual, in-depth, semi structured, and&#xD;
        audio-recorded interviews.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females 18&gt;45, between 28-38 weeks pregnant, lives in Gainesville, Florida, and&#xD;
             committed to exclusively breastfeeding through 6 months.&#xD;
&#xD;
          -  Females 18&gt;45, actively breastfeeding for &lt;12 months and lives in Gainesville, Florida&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers who do not plan to exclusively breastfeed their infant for at least the first&#xD;
             6 months or actively breastfeeding.&#xD;
&#xD;
          -  Mothers who do not live in Gainesville, FL&#xD;
&#xD;
          -  Mothers who are not between the ages of 18-45&#xD;
&#xD;
          -  Mothers who are not between 28-38 weeks of gestation or a breastfeeding mother.&#xD;
&#xD;
          -  Mothers who have only one breast which is capable of producing milk and/or have a&#xD;
             history of inadequate milk production.&#xD;
&#xD;
          -  Mothers who have consumed alcohol during this pregnancy.&#xD;
&#xD;
          -  Mothers who have abused drugs during this pregnancy.&#xD;
&#xD;
          -  Mothers who have smoked during this pregnancy.&#xD;
&#xD;
          -  Mothers who have been diagnosed with pre-eclampsia during this pregnancy.&#xD;
&#xD;
          -  Mothers who have had a previous pre-term delivery (baby born 2 months before the due&#xD;
             date or &lt;35 weeks).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominick J Lemas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magda Francois</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Retention</keyword>
  <keyword>Lactation</keyword>
  <keyword>Human milk</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Clinical Research Studies</keyword>
  <keyword>BEACH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In accordance with the NIH Data Sharing Policy of award 1U24DK097193, all data generated by Southeast Center for Integrated Metabolomics (SECIM), along with the corresponding metadata, will be deposited into the NIH Metabolomics Data Repository and Coordinating Center (DRCC) as soon as all quality control steps are completed. Data will be embargoed for one year and, after the expiration of the embargo, made visible to the scientific community regardless of publication status for the data.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03036696
org study id: IRB201601909
nct id: NCT03036696
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize;
      clinical study recruitment and retention, patient-centered outcomes, and stool collection
      procedures.
This is an interview study that will enroll mothers during 28 weeks or greater of pregnancy
      and assess recruitment, patient-centered outcomes, and stool collection procedures via
      individualized interviews and data collection. Participants will be recruited from the
      greater Gainesville, FL area. Data collection will include questionnaires/surveys as well as
      minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab,
      and urine collection. Participants will be seen at a location convenient for them.
observational model: Cohort
time perspective: Prospective
measure: Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.
time frame: 6 months
description: Interviews will be analyzed to determine the efficacy of common strategies used to recruit pregnant and breastfeeding mothers into CRTs, challenges or barriers that would preclude women from enrolling and participating in CRTs, their preferences for incentives, as well their preference and methods related to non-invasive sample collection.
measure: Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)
time frame: 1 year
measure: Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)
time frame: 1 year
measure: Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)
time frame: 1 year
arm group label: Pregnant Mothers Interview
description: (1) 18 years old or over, (2) between 28-38 weeks of pregnancy, (3) lives in Gainesville, Florida, and (4) are committed to exclusively breastfeeding through 6 months.
arm group label: Breastfeeding Mothers Interview
description: (1) 18 years old or over, (2) actively breastfeeding infant less than 12 months of age, and (3) lives in Gainesville, Florida.
intervention type: Other
intervention name: Pregnant Mothers Interview
description: Pregnant mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection and preferences for methods related to non-invasive sample collection.
Data collection for pregnant mothers includes Clinical Health Update (3rd trimester) and Physical Activity questionnaires.
The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.
arm group label: Pregnant Mothers Interview
intervention type: Other
intervention name: Breastfeeding Mothers Interview
description: Breastfeeding mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection, and preferences for methods related to non-invasive sample collection.
Data collection for breastfeeding mothers includes Clinical Health update (post-natal), Infant Feeding, and Physical Activity questionnaires.
The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.
arm group label: Breastfeeding Mothers Interview
Non-invasive biospecimens include stool, saliva, blood, urine, human milk, and vaginal swab.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominick J Lemas, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: In accordance with the NIH Data Sharing Policy of award 1U24DK097193, all data generated by Southeast Center for Integrated Metabolomics (SECIM), along with the corresponding metadata, will be deposited into the NIH Metabolomics Data Repository and Coordinating Center (DRCC) as soon as all quality control steps are completed. Data will be embargoed for one year and, after the expiration of the embargo, made visible to the scientific community regardless of publication status for the data.