Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Linda C. Gallo, San Diego State University Identifier:
First received: October 11, 2006
Last updated: January 4, 2012
Last verified: January 2012

October 11, 2006
January 4, 2012
October 2006
June 2010   (final data collection date for primary outcome measure)
Stress, psychosocial risk and resilient factors, socio-cultural factors, and bio-behavioral markers of cardiovascular risk [ Time Frame: Measured at completion of sample analysis ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00387166 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Socioeconomic Status, Psychosocial Factors, and CVD Risk in Mexican-American Women
Cardiovascular Risk Disparities: Socio-Emotional Pathways

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.

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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample

The study population will include healthy Mexican-American women from the South San Diego community.

  • Hypertension
  • Cardiovascular Disease
  • Metabolic Disorders
Not Provided
Mexican-American women, aged 40-65

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (final data collection date for primary outcome measure)

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
40 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
1339, R01HL081604-01A1, G00006532, R01 HL081604-01A1
Linda C. Gallo, San Diego State University
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
San Diego State University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP