Socioeconomic Status, Psychosocial Factors, and CVD Risk in Mexican-American Women

Sponsor
San Diego State University (Other)
Overall Status
Completed
CT.gov ID
NCT00387166
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
304
1
44
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    304 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiovascular Risk Disparities: Socio-Emotional Pathways
    Study Start Date :
    Oct 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Mexican-American women, aged 40-65

    Outcome Measures

    Primary Outcome Measures

    1. Stress, psychosocial risk and resilient factors, socio-cultural factors, and bio-behavioral markers of cardiovascular risk [Measured at completion of sample analysis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Self identifies as Mexican-American

    • Resides in Chula Vista or National City

    • Sufficiently mobile to complete ambulatory blood pressure assessment

    Exclusion Criteria:
    • Pregnant

    • Current or historical cardiovascular disease

    • Current Type II diabetes

    • Cancer treatment in the 10 years before study entry

    • Bleeding disorder

    • Use of medications with autonomic effects

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Diego State University, Institute for Behavioral and Community Health San Diego California United States 92123

    Sponsors and Collaborators

    • San Diego State University
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Linda C. Gallo, PhD, San Diego State University
    • Principal Investigator: John Elder, PhD, San Diego State University
    • Principal Investigator: Paul Mills, PhD, University of California, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Linda C. Gallo, Professor, San Diego State University
    ClinicalTrials.gov Identifier:
    NCT00387166
    Other Study ID Numbers:
    • 1339
    • R01HL081604-01A1
    • G00006532
    First Posted:
    Oct 12, 2006
    Last Update Posted:
    Jan 6, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Linda C. Gallo, Professor, San Diego State University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 6, 2012