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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387166
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : January 6, 2012
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Linda C. Gallo, San Diego State University

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
Hypertension Cardiovascular Disease Metabolic Disorders

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

Mexican-American women, aged 40-65

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

Biospecimen Retention:   Samples Without DNA
Blood and urine specimens were collected to identify stress hormones and inflammatory markers. Whole blood, plasma, and serum are stored for possible future assays based on new discoveries.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include healthy Mexican-American women from the South San Diego community.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00387166

United States, California
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)
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

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Linda C. Gallo, Professor, San Diego State University Identifier: NCT00387166     History of Changes
Other Study ID Numbers: 1339
R01HL081604-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Keywords provided by Linda C. Gallo, San Diego State University:
Type 2 Diabetes
Blood Pressure
Social Context

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Diseases