Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387166
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2006-10-11
Brief Title:
Socioeconomic Status Psychosocial Factors and CVD Risk in Mexican-American Women
Sponsor:
San Diego State University
Organization:
San Diego State University
Study Overview
Official Title:
Cardiovascular Risk Disparities Socio-Emotional Pathways
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiovascular disease CVD is the leading cause of death in American women claiming on average 40 of all female deaths each year Although the number of CVD-related deaths in the United States has decreased over the last several decades the rate of decline has been less for women than for men Specifically minority women of low socioeconomic status make up a disproportionately high number of CVD cases and related deaths Previous studies suggest that in addition to many other variables psychosocial variables may contribute to ethnic CVD disparities More research however is needed to help understand and reduce these differences This study will examine the associations among socioeconomic status psychological and social factors CVD biomarkers and CVD in Mexican-American women
Detailed Description:
One in four women in the United States has some form of CVD which includes heart disease high blood pressure and heart attack Minority and low socioeconomic status populations show particularly disproportionate rates of CVD morbidity and mortality Previous research suggests that individuals with lower social status may suffer negative emotional and physical health consequences due to increased stress experienced across multiple areas of life It is believed that stress may directly affect behavioral physiological and emotional risk processes which have all been linked to increased CVD risk In addition people with low socioeconomic status are often less capable of seeking psychosocial resources with which to manage stress making them especially vulnerable to the associated physical and emotional wear and tear More information is needed on the effects of psychosocial variables on the cardiovascular health of minority specifically Mexican-American women This study will examine the associations among socioeconomic status psychological and social factors CVD biomarkers and CVD in Mexican-American women
Participation in this study will involve two home visits with total participation time lasting about 6 hours During the first study visit participants will complete a variety of questionnaires on stressful experiences social relationships background and culture thoughts and emotions health habits and medical history Participants will also have their blood pressure measured and will be given a container and instructions to perform a 12-hour overnight urine collection
During the second study visit occurring a couple of days after the first visit participants will undergo a blood draw physical and vital sign measurements and a training session on how to use an ambulatory blood pressure monitor and handheld computer diary Participants who fit properly into the arm cuff of the ambulatory blood pressure monitor will then be asked to wear the monitor for 36 hours Every time the monitor records a blood pressure reading participants will be asked to use their handheld computer diary and answer questions about temperature exercise posture stress mood and social interactions There will be a total of 52 to 56 diary entries taking between 2 and 3 minutes to complete each entry Within 1 month participants will receive a letter summarizing their health profile in terms of weight cholesterol levels and blood glucose Participants will also be provided with information on seeking appropriate treatments for any health problems discovered on their profile
Participation in this study will involve two home visits with total participation time lasting about 6 hours During the first study visit participants will complete a variety of questionnaires on stressful experiences social relationships background and culture thoughts and emotions health habits and medical history Participants will also have their blood pressure measured and will be given a container and instructions to perform a 12-hour overnight urine collection
During the second study visit occurring a couple of days after the first visit participants will undergo a blood draw physical and vital sign measurements and a training session on how to use an ambulatory blood pressure monitor and handheld computer diary Participants who fit properly into the arm cuff of the ambulatory blood pressure monitor will then be asked to wear the monitor for 36 hours Every time the monitor records a blood pressure reading participants will be asked to use their handheld computer diary and answer questions about temperature exercise posture stress mood and social interactions There will be a total of 52 to 56 diary entries taking between 2 and 3 minutes to complete each entry Within 1 month participants will receive a letter summarizing their health profile in terms of weight cholesterol levels and blood glucose Participants will also be provided with information on seeking appropriate treatments for any health problems discovered on their profile
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| G00006532 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01HL081604-01A1 |
| R01HL081604-01A1 | NIH | None | None |