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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linda C. Gallo, San Diego State University
ClinicalTrials.gov Identifier:
NCT00387166
First received: October 11, 2006
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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
Hypertension
Cardiovascular Disease
Metabolic Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Risk Disparities: Socio-Emotional Pathways

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • 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 ]

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.


Enrollment: 304
Study Start Date: October 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Mexican-American women, aged 40-65

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders 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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387166

Locations
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
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Linda C. Gallo, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT00387166     History of Changes
Other Study ID Numbers: 1339, R01HL081604-01A1, G00006532, R01 HL081604-01A1
Study First Received: October 11, 2006
Last Updated: January 4, 2012
Health Authority: United States: Federal Government

Keywords provided by San Diego State University:
Type 2 Diabetes
Cardiovascular
Blood Pressure
Hispanic
Women
Social Context
Psychosocial

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014