Healthy AgingNCT06552702
Race and Socioeconomic Position: Examining Common Social Pathways to Disease Risk
An observational study of Healthy Aging, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Healthy Aging
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 16 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Black American or White American between the ages of 35 and 70.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of AL Psychology Department
Tuscaloosa, Alabama, 35404
About this study
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.
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- There is no intervention
- Keywords
- socioeconomic status, race, stress, social relationships, ambulatory blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Systolic Blood Pressure
Mean
Measured: during four days of ambulatory monitoring
Ambulatory Diastolic Blood Pressure
Mean
Measured: during four days of ambulatory monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start28 Mar 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Jenny Cundiff, Principal investigator, University of Alabama at BirminghamKarlene Ball, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552702
- Sponsor's protocol ID
- 21044507
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Jones CP. Levels of racism: a theoretic framework and a gardener's tale. Am J Public Health. 2000 Aug;90(8):1212-5. doi: 10.2105/ajph.90.8.1212.
PubMed 10936998Bailey ZD, Krieger N, Agenor M, Graves J, Linos N, Bassett MT. Structural racism and health inequities in the USA: evidence and interventions. Lancet. 2017 Apr 8;389(10077):1453-1463. doi: 10.1016/S0140-6736(17)30569-X.
PubMed 28402827Krieger N, Chen JT, Waterman PD, Rehkopf DH, Subramanian SV. Painting a truer picture of US socioeconomic and racial/ethnic health inequalities: the Public Health Disparities Geocoding Project. Am J Public Health. 2005 Feb;95(2):312-23. doi: 10.2105/AJPH.2003.032482.
PubMed 15671470Williams DR, Mohammed SA. Racism and Health I: Pathways and Scientific Evidence. Am Behav Sci. 2013 Aug 1;57(8):10.1177/0002764213487340. doi: 10.1177/0002764213487340.
PubMed 24347666
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Race and Socioeconomic Position: Examining Common Social Pathways to Disease Risk
- ClinicalTrials.gov ID
- NCT06552702
- Acronym / sponsor ID
- 21044507
- Conditions
- Healthy Aging
- Keywords
- socioeconomic status, race, stress, social relationships, ambulatory blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community sample | – | Other: There is no interventionBlack Americans (8 high SEP, 8 low SEP) and White Americans (8 high SEP, 8 low SEP) between the ages of 35 and 70 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Black American or White American between the ages of 35 and 70.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no interventionThere is no intervention. | Other | Community sample |
Primary outcome
Ambulatory Systolic Blood Pressure
Time frame: during four days of ambulatory monitoring
Mean
Ambulatory Diastolic Blood Pressure
Time frame: during four days of ambulatory monitoring
Mean
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 10936998Jones CP. Levels of racism: a theoretic framework and a gardener's tale. Am J Public Health. 2000 Aug;90(8):1212-5. doi: 10.2105/ajph.90.8.1212.
- Background: PubMed 28402827Bailey ZD, Krieger N, Agenor M, Graves J, Linos N, Bassett MT. Structural racism and health inequities in the USA: evidence and interventions. Lancet. 2017 Apr 8;389(10077):1453-1463. doi: 10.1016/S0140-6736(17)30569-X.
- Background: PubMed 15671470Krieger N, Chen JT, Waterman PD, Rehkopf DH, Subramanian SV. Painting a truer picture of US socioeconomic and racial/ethnic health inequalities: the Public Health Disparities Geocoding Project. Am J Public Health. 2005 Feb;95(2):312-23. doi: 10.2105/AJPH.2003.032482.
- Background: PubMed 24347666Williams DR, Mohammed SA. Racism and Health I: Pathways and Scientific Evidence. Am Behav Sci. 2013 Aug 1;57(8):10.1177/0002764213487340. doi: 10.1177/0002764213487340.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Cundiff principal investigator
University of Alabama at Birmingham
Karlene Ball study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Systolic Blood Pressure (time frame: during four days of ambulatory monitoring). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06552702, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.