Race and Socioeconomic Position: Examining Common Social Pathways to Disease Risk

August 9, 2024 updated by: University of Alabama, Tuscaloosa
Black Americans and those of lower socioeconomic position (SEP) are at higher risk for multiple diseases of aging and shorter lifespans, but the psychophysiological mechanisms that may account for these effects are not clear. The overarching objective of this pilot grant is to improve our understanding of the proximal social exposures and subsequent psychobiological processes that contribute to racial and socioeconomic health disparities. Precisely understanding what these mutable social and psychological mechanisms are is necessary in order to identify intervention targets at the level of the individual.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Black Americans and those of lower socioeconomic position (SEP) are at higher risk for multiple diseases of aging and shorter lifespans. Though these disparities are well-documented, the mechanisms that may account for them are still poorly understood. Low income or Black race do not, themselves, cause individuals to become sick. Instead, the social context and exposures associated with these personal attributes give rise to differential risk (1-3). Black race and lower SEP are overlapping in the United States and race and SEP may share common social exposures that contribute to disease risk because both Blacks and individuals of lower SEP are socially marginalized (e.g., devalued, pushed to the lower margins of society) and thus exposed to more stress associated with lower hierarchical rank (4). However, no studies to our knowledge have been designed to examine whether day-to-day social exposures common across race and SEP may contribute to higher overall disease burden in these groups. In this project, investigators examine whether daily social interaction patterns help to explain how race and SEP may be linked with well-established psychobiological pathways to disease (affect, behavior, and physiology). With respect to each of these pathways, investigators examine the extent to which within-person changes in social processes may be associated with effects that mirror (and thus could explain) between-group differences. For example, interactions in which one experiences a higher degree of disrespect may be associated with momentary changes in affect, behavior, and physiology that confer disease risk. Examination of these within-person processes allows for stronger causal inference and is directly relevant to the development of individual-level interventions (e.g., targeting cognitive, behavioral, and affective processes). These findings can directly inform individual and group interventions for stress reduction in health disparity populations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
        • University of AL Psychology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Recruitment will target Black Americans (8 high SEP, 8 low SEP) and White Americans (8 high SEP, 8 low SEP) between the ages of 35 and 70. Low SEP will be defined as a score of 1 to 3 on the MacArthur (ladder) scale of subjective social status (range 1-10), and high SEP as a score of 8-10 on the same scale.

Description

Inclusion Criteria:

- Black American or White American between the ages of 35 and 70.

Exclusion Criteria:

  • Conditions that require immediate treatment (e.g., Stage 2 hypertension; resting blood pressure > 160/100 mmHg)
  • Excessive alcohol consumption (> 5 portions, > 3 times per week)
  • Frequent illicit drug use
  • Schizophrenia or bipolar disorder
  • Permanent neurological deficit
  • Shift work
  • Current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Community sample
Black Americans (8 high SEP, 8 low SEP) and White Americans (8 high SEP, 8 low SEP) between the ages of 35 and 70
Other: There is no intervention
There is no intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ambulatory Systolic Blood Pressure
Time Frame: during four days of ambulatory monitoring
Mean
during four days of ambulatory monitoring
Ambulatory Diastolic Blood Pressure
Time Frame: during four days of ambulatory monitoring
Mean
during four days of ambulatory monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama, Tuscaloosa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jenny Cundiff, University of Alabama at Birmingham
  • Study Director: Karlene Ball, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21044507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will also be presented at international scientific meetings regularly attended by the PI (e.g., American Psychosomatic Society, Society for Behavioral Medicine) and shared at both national and regional RCMAR conferences. Preliminary findings from this proposed study will be used to apply for NIH R-series funding to conduct a larger study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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