- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03013179
Intergenerational Blood Pressure Study (InterGEN)
18. marts 2020 opdateret af: Yale University
Intergenerational Impact of Genetic and Psychological Factors on Blood Pressure
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Connecticut
-
Orange, Connecticut, Forenede Stater, 06477
- Yale University School of Nursing
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Black/African American women and their 3-5 year old children in CT
Beskrivelse
Inclusion Criteria:
Mothers must:
- Self-identify as Black/African American
- Be 21 years or older
- Have a 3-5 year old biological child
- Not be impaired by a though disorder, psychosis, or mania
- Confirm that their child will be able to provide saliva sample for DNA
- Be English-speaking
Exclusion Criteria:
- None
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Black/African American Women and their 3-5 year old children
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure
Tidsramme: 18 months
|
Manual blood pressure taken according to JNC-7 guidelines, average of 3 resting blood pressure measurements
|
18 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jacquelyn Y Taylor, PhD, Yale University
- Ledende efterforsker: Cindy A Crusto, PhD, Yale University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2015
Primær færdiggørelse (Faktiske)
1. juni 2019
Studieafslutning (Faktiske)
1. marts 2020
Datoer for studieregistrering
Først indsendt
5. januar 2017
Først indsendt, der opfyldte QC-kriterier
5. januar 2017
Først opslået (Skøn)
6. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1311012986
- 5R01NR013520 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forhøjet blodtryk
-
VIVUS LLCIkke rekrutterer endnuPulmonal arteriel hypertension | Pulmonal arteriel hypertension (PAH) (WHO Group 1 PH) | Pulmonal arteriel hypertension (PAH) | Pulmonal arteriel hypertension WHO gruppe I | Pulmonal arteriel hypertension PAH
-
Inhibikase TherapeuticsIkke rekrutterer endnuPulmonal arteriel hypertension (PAH)
-
Philipps University MarburgMSD Sharp & Dohme GmbH, GermanyIkke rekrutterer endnu
-
BayerAfsluttet
-
National Taiwan University Hospital Hsin-Chu BranchRekrutteringHypertension, essentiel | Hypertension, maskeretTaiwan
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc...Ikke rekrutterer endnuPulmonal hypertension | Pulmonal arteriel hypertension (PAH)Forenede Stater
-
BackBeat Medical IncIkke rekrutterer endnuHypertension, systolisk | Hypertension (HTN) | Hjertesvigt med bevaret ejektionsfraktion (HFpEF)Georgien
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI); University of MichiganIkke rekrutterer endnuPulmonal arteriel hypertension (PAH)Forenede Stater
-
University of Sao Paulo General HospitalRekrutteringPulmonal arteriel hypertension (PAH)Brasilien
-
University Hospital, BrestIkke rekrutterer endnuPulmonal arteriel hypertension (PAH)Frankrig