<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/NCT03013179</url>
  </required_header>
  <id_info>
    <org_study_id>1311012986</org_study_id>
    <secondary_id>5R01NR013520</secondary_id>
    <nct_id>NCT03013179</nct_id>
  </id_info>
  <brief_title>Intergenerational Blood Pressure Study</brief_title>
  <acronym>InterGEN</acronym>
  <official_title>Intergenerational Impact of Genetic and Psychological Factors on Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project, the Intergenerational Blood Pressure Study, is a 5 year research study funded&#xD;
      by the National Institutes of Health/National Institute of Nursing Research and led by the&#xD;
      Yale University School of Nursing and The Consultation Center at the Yale University School&#xD;
      of Medicine, Department of Psychiatry in partnership with Head Start programs across CT. The&#xD;
      investigators seek to reduce hypertension health disparities among underserved Black/African&#xD;
      American children and their mothers by conducting community-based research to better&#xD;
      understand the genetic, psychological, and environmental factors that may contribute to high&#xD;
      blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine: (1) the impact of (GXE) genetic and psychological environmental&#xD;
      factors (discrimination, depression, and parenting behaviors) on the health of African&#xD;
      American (AA) children aged 3 through 5 years and (2) the GXE risk for hypertension (HTN) in&#xD;
      AA women and children. The overall goal of this project is to delineate the psychobiological&#xD;
      (GXE interaction) mechanisms through which AA mothers' perceived racial discrimination,&#xD;
      mental health, and parenting behavior affect their own and their young children's blood&#xD;
      pressure (BP) over time. The research will examine both genetic (candidate gene and&#xD;
      epigenetic effects) and psychological (maternal perceived racial discrimination, mental&#xD;
      health, and parenting behavior) interaction effects on BP on this population. The&#xD;
      investigators will employ a psychobiological approach by: utilizing psychological and&#xD;
      biological assessments using a longitudinal cohort research design, a 2-step candidate gene&#xD;
      and epigenetic methodology, and use of ancestry informative markers to account for population&#xD;
      stratification admixture to explore GXE interactions on BP in AA mothers and children. Data&#xD;
      analysis for the study will be conducted using multiple mixed modeling, cross-validation, and&#xD;
      false discovery rate methods. The investigators will enroll 250 AA children aged 3 through 5&#xD;
      years and their (n=250) mothers/maternal caregivers. The investigators will assess mother and&#xD;
      child factors every six months for 2 years. The investigators propose the following: Aim 1:&#xD;
      Examine the GXE interaction and epigenetic effects of mothers' perceived racial&#xD;
      discrimination and its influence on BP over a period of two years. Aim 2: Examine the GXE&#xD;
      interaction and epigenetic effects of mothers' mental health status [symptoms of depression]&#xD;
      and its influence on BP over a period of two years. Aim 3: Examine the GXE interaction and&#xD;
      epigenetic effects of mothers' parenting behavior and its influence on BP over a period of&#xD;
      two years. This project supports the National Institute of Nursing Research mission &quot;to&#xD;
      promote and improve the health of individuals, families, communities, and populations&quot; by&#xD;
      conducting basic research on the health and illness of women and young children. The proposed&#xD;
      research extends nursing science by integrating the biological (genetics) and behavioral&#xD;
      (psychology) components that can inform the combination of multi-level factors that&#xD;
      contribute to AAs having the highest incidence of HTN in the US. Findings from this project&#xD;
      can contribute to developing interventions that address genetic and psychological factors to&#xD;
      reduce these risks for HTN.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">June 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>Blood Pressure</measure>
    <time_frame>18 months</time_frame>
    <description>Manual blood pressure taken according to JNC-7 guidelines, average of 3 resting blood pressure measurements</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Black/African American Women and their 3-5 year old children</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva sample for DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Black/African American women and their 3-5 year old children in CT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Mothers must:&#xD;
&#xD;
          -  Self-identify as Black/African American&#xD;
&#xD;
          -  Be 21 years or older&#xD;
&#xD;
          -  Have a 3-5 year old biological child&#xD;
&#xD;
          -  Not be impaired by a though disorder, psychosis, or mania&#xD;
&#xD;
          -  Confirm that their child will be able to provide saliva sample for DNA&#xD;
&#xD;
          -  Be English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacquelyn Y Taylor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cindy A Crusto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University School of Nursing</name>
      <address>
        <city>Orange</city>
        <state>Connecticut</state>
        <zip>06477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://intergen.yale.edu/</url>
    <description>Click here for more information about this study: Intergenerational Blood Pressure Study</description>
  </link>
  <reference>
    <citation>Taylor JY, Wright ML, Crusto CA, Sun YV. The Intergenerational Impact of Genetic and Psychological Factors on Blood Pressure (InterGEN) Study: Design and Methods for Complex DNA Analysis. Biol Res Nurs. 2016 Oct;18(5):521-30. doi: 10.1177/1099800416645399. Epub 2016 Apr 26.</citation>
    <PMID>27118148</PMID>
  </reference>
  <reference>
    <citation>Crusto CA, Barcelona de Mendoza V, Connell CM, Sun YV, Taylor JY. The Intergenerational Impact of Genetic and Psychological Factors on Blood Pressure Study (InterGEN): Design and Methods for Recruitment and Psychological Measures. Nurs Res. 2016 Jul-Aug;65(4):331-8. doi: 10.1097/NNR.0000000000000163.</citation>
    <PMID>27362519</PMID>
  </reference>
  <reference>
    <citation>Barcelona de Mendoza V, Wright ML, Agaba C, Prescott L, Desir A, Crusto CA, Sun YV, Taylor JY. A Systematic Review of DNA Methylation and Preterm Birth in African American Women. Biol Res Nurs. 2017 May;19(3):308-317. doi: 10.1177/1099800416669049. Epub 2016 Sep 19.</citation>
    <PMID>27646016</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>March 18, 2020</last_update_submitted>
  <last_update_submitted_qc>March 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Genomic Data Sharing Plan in place, in accordance with NIH regulations Only de-identified genomic data will be shared with dbGaP, to which other researchers will be able to apply for access. Data will be submitted within 1 year after analyses are complete.</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/NCT03013179
org study id: 1311012986
secondary id: 5R01NR013520
nct id: NCT03013179
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This project, the Intergenerational Blood Pressure Study, is a 5 year research study funded
      by the National Institutes of Health/National Institute of Nursing Research and led by the
      Yale University School of Nursing and The Consultation Center at the Yale University School
      of Medicine, Department of Psychiatry in partnership with Head Start programs across CT. The
      investigators seek to reduce hypertension health disparities among underserved Black/African
      American children and their mothers by conducting community-based research to better
      understand the genetic, psychological, and environmental factors that may contribute to high
      blood pressure.
This study will examine: (1) the impact of (GXE) genetic and psychological environmental
      factors (discrimination, depression, and parenting behaviors) on the health of African
      American (AA) children aged 3 through 5 years and (2) the GXE risk for hypertension (HTN) in
      AA women and children. The overall goal of this project is to delineate the psychobiological
      (GXE interaction) mechanisms through which AA mothers' perceived racial discrimination,
      mental health, and parenting behavior affect their own and their young children's blood
      pressure (BP) over time. The research will examine both genetic (candidate gene and
      epigenetic effects) and psychological (maternal perceived racial discrimination, mental
      health, and parenting behavior) interaction effects on BP on this population. The
      investigators will employ a psychobiological approach by: utilizing psychological and
      biological assessments using a longitudinal cohort research design, a 2-step candidate gene
      and epigenetic methodology, and use of ancestry informative markers to account for population
      stratification admixture to explore GXE interactions on BP in AA mothers and children. Data
      analysis for the study will be conducted using multiple mixed modeling, cross-validation, and
      false discovery rate methods. The investigators will enroll 250 AA children aged 3 through 5
      years and their (n=250) mothers/maternal caregivers. The investigators will assess mother and
      child factors every six months for 2 years. The investigators propose the following: Aim 1:
      Examine the GXE interaction and epigenetic effects of mothers' perceived racial
      discrimination and its influence on BP over a period of two years. Aim 2: Examine the GXE
      interaction and epigenetic effects of mothers' mental health status [symptoms of depression]
      and its influence on BP over a period of two years. Aim 3: Examine the GXE interaction and
      epigenetic effects of mothers' parenting behavior and its influence on BP over a period of
      two years. This project supports the National Institute of Nursing Research mission "to
      promote and improve the health of individuals, families, communities, and populations" by
      conducting basic research on the health and illness of women and young children. The proposed
      research extends nursing science by integrating the biological (genetics) and behavioral
      (psychology) components that can inform the combination of multi-level factors that
      contribute to AAs having the highest incidence of HTN in the US. Findings from this project
      can contribute to developing interventions that address genetic and psychological factors to
      reduce these risks for HTN.
observational model: Cohort
time perspective: Prospective
measure: Blood Pressure
time frame: 18 months
description: Manual blood pressure taken according to JNC-7 guidelines, average of 3 resting blood pressure measurements
arm group label: Black/African American Women and their 3-5 year old children
Saliva sample for DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jacquelyn Y Taylor, PhD
role: Principal Investigator
affiliation: Yale University
last name: Cindy A Crusto, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
url: http://intergen.yale.edu/
description: Click here for more information about this study: Intergenerational Blood Pressure Study
citation: Taylor JY, Wright ML, Crusto CA, Sun YV. The Intergenerational Impact of Genetic and Psychological Factors on Blood Pressure (InterGEN) Study: Design and Methods for Complex DNA Analysis. Biol Res Nurs. 2016 Oct;18(5):521-30. doi: 10.1177/1099800416645399. Epub 2016 Apr 26.
PMID: 27118148
citation: Crusto CA, Barcelona de Mendoza V, Connell CM, Sun YV, Taylor JY. The Intergenerational Impact of Genetic and Psychological Factors on Blood Pressure Study (InterGEN): Design and Methods for Recruitment and Psychological Measures. Nurs Res. 2016 Jul-Aug;65(4):331-8. doi: 10.1097/NNR.0000000000000163.
PMID: 27362519
citation: Barcelona de Mendoza V, Wright ML, Agaba C, Prescott L, Desir A, Crusto CA, Sun YV, Taylor JY. A Systematic Review of DNA Methylation and Preterm Birth in African American Women. Biol Res Nurs. 2017 May;19(3):308-317. doi: 10.1177/1099800416669049. Epub 2016 Sep 19.
PMID: 27646016
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Yes
ipd description: Genomic Data Sharing Plan in place, in accordance with NIH regulations Only de-identified genomic data will be shared with dbGaP, to which other researchers will be able to apply for access. Data will be submitted within 1 year after analyses are complete.