NCT03013179

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

4.2 years

First QC Date

January 5, 2017

Last Update Submit

March 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Manual blood pressure taken according to JNC-7 guidelines, average of 3 resting blood pressure measurements

    18 months

Study Arms (1)

Black/African American Women and their 3-5 year old children

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Black/African American women and their 3-5 year old children in CT

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Nursing

Orange, Connecticut, 06477, United States

Location

Related Publications (3)

  • 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: 27118148BACKGROUND
  • 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: 27362519BACKGROUND
  • 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: 27646016BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva sample for DNA

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jacquelyn Y Taylor, PhD

    Yale University

    PRINCIPAL INVESTIGATOR
  • Cindy A Crusto, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 6, 2017

Study Start

April 1, 2015

Primary Completion

June 1, 2019

Study Completion

March 1, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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.

Locations