Intergenerational Blood Pressure Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Minneapolis Children's Blood Pressure Study

NCT00005141

Cardiovascular Diseases Heart Diseases Hypertension +1 more

COMPLETED

Blood Pressure Tracking--Childhood to Young Adulthood

NCT00005421

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED

Blood Pressure Control--Racial and Psychosocial Influences

NCT00005685

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED

Youth-Led Intervention to Improve Blood Pressure

NCT05029687

Hypertension Adolescent Behavior Health Knowledge, Attitudes, Practice

COMPLETED NA

Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure

NCT00384241

Hypertension

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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