Intergenerational Blood Pressure Study

Completed

• Conditions: Hypertension

• Registration Number: NCT03013179
• Lead Sponsor: Yale University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2019-06
• Status Verified: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Pressure	18 months	Manual blood pressure taken according to JNC-7 guidelines, average of 3 resting blood pressure measurements

Trial Locations

Locations (1)

Yale University School of Nursing; 🇺🇸 Orange, Connecticut, United States