HypertensionNCT00387166
Socioeconomic Status, Psychosocial Factors, and CVD Risk in Mexican-American Women
An observational study of Hypertension and Cardiovascular Disease, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Disease, Metabolic Disorders
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include healthy Mexican-American women from the South San Diego community.
Who may be able to join
- Self identifies as Mexican-American
- Resides in Chula Vista or National City
- Sufficiently mobile to complete ambulatory blood pressure assessment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University, Institute for Behavioral and Community Health
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Cardiovascular Disease, Metabolic Disorders
- Keywords
- Type 2 Diabetes, Cardiovascular, Blood Pressure, Hispanic, Women, Social Context, Psychosocial
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Metabolic Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Mexican-American women, aged 40-65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress, psychosocial risk and resilient factors, socio-cultural factors, and bio-behavioral markers of cardiovascular risk
Measured: Measured at completion of sample analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Linda C. Gallo, San Diego State University
- Investigators
- Linda C. Gallo, PhD, Principal investigator, San Diego State UniversityJohn Elder, PhD, Principal investigator, San Diego State UniversityPaul Mills, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387166
- Sponsor's protocol ID
- 1339
- Other IDs
- R01HL081604-01A1, G00006532
- Status last verified
- Jan 2012
- First submitted
- 11 Oct 2006
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gallo LC, Matthews KA. Understanding the association between socioeconomic status and physical health: do negative emotions play a role? Psychol Bull. 2003 Jan;129(1):10-51. doi: 10.1037/0033-2909.129.1.10.
PubMed 12555793Matthews KA, Gallo LC. Psychological perspectives on pathways linking socioeconomic status and physical health. Annu Rev Psychol. 2011;62:501-30. doi: 10.1146/annurev.psych.031809.130711.
PubMed 20636127Gallo LC, Penedo FJ, Espinosa de los Monteros K, Arguelles W. Resiliency in the face of disadvantage: do Hispanic cultural characteristics protect health outcomes? J Pers. 2009 Dec;77(6):1707-46. doi: 10.1111/j.1467-6494.2009.00598.x. Epub 2009 Sep 30.
PubMed 19796063Gallo LC, Fortmann AL, Roesch SC, Barrett-Connor E, Elder JP, de los Monteros KE, Shivpuri S, Mills PJ, Talavera GA, Matthews KA. Socioeconomic status, psychosocial resources and risk, and cardiometabolic risk in Mexican-American women. Health Psychol. 2012 May;31(3):334-42. doi: 10.1037/a0025689. Epub 2011 Nov 7.
PubMed 22059620Gallo LC, Jimenez JA, Shivpuri S, Espinosa de los Monteros K, Mills PJ. Domains of chronic stress, lifestyle factors, and allostatic load in middle-aged Mexican-American women. Ann Behav Med. 2011 Feb;41(1):21-31. doi: 10.1007/s12160-010-9233-1.
PubMed 20878511Gonzalez P, Castaneda SF, Mills PJ, Talavera GA, Elder JP, Gallo LC. Determinants of breast, cervical and colorectal cancer screening adherence in Mexican-American women. J Community Health. 2012 Apr;37(2):421-33. doi: 10.1007/s10900-011-9459-2.
PubMed 21874364Shivpuri S, Gallo LC, Mills PJ, Matthews KA, Elder JP, Talavera GA. Trait anger, cynical hostility and inflammation in Latinas: variations by anger type? Brain Behav Immun. 2011 Aug;25(6):1256-63. doi: 10.1016/j.bbi.2011.04.016. Epub 2011 May 1.
PubMed 21554946Gallo LC, Fortmann AL, de Los Monteros KE, Mills PJ, Barrett-Connor E, Roesch SC, Matthews KA. Individual and neighborhood socioeconomic status and inflammation in Mexican American women: what is the role of obesity? Psychosom Med. 2012 Jun;74(5):535-42. doi: 10.1097/PSY.0b013e31824f5f6d. Epub 2012 May 11.
PubMed 22582313
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Disparities: Socio-Emotional Pathways
- ClinicalTrials.gov ID
- NCT00387166
- Acronym / sponsor ID
- 1339
- Conditions
- Hypertension, Cardiovascular Disease, Metabolic Disorders
- Keywords
- Type 2 Diabetes, Cardiovascular, Blood Pressure, Hispanic, Women, Social Context, Psychosocial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mexican-American women, aged 40-65 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include healthy Mexican-American women from the South San Diego community.
Key inclusion criteria (3 listed)
- Self identifies as Mexican-American
- Resides in Chula Vista or National City
- Sufficiently mobile to complete ambulatory blood pressure assessment
Key exclusion criteria (6 listed)
- Pregnant
- Current or historical cardiovascular disease
- Current Type II diabetes
- Cancer treatment in the 10 years before study entry
- Bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stress, psychosocial risk and resilient factors, socio-cultural factors, and bio-behavioral markers of cardiovascular risk
Time frame: Measured at completion of sample analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- Background: PubMed 12555793Gallo LC, Matthews KA. Understanding the association between socioeconomic status and physical health: do negative emotions play a role? Psychol Bull. 2003 Jan;129(1):10-51. doi: 10.1037/0033-2909.129.1.10.
- Background: PubMed 20636127Matthews KA, Gallo LC. Psychological perspectives on pathways linking socioeconomic status and physical health. Annu Rev Psychol. 2011;62:501-30. doi: 10.1146/annurev.psych.031809.130711.
- Background: PubMed 19796063Gallo LC, Penedo FJ, Espinosa de los Monteros K, Arguelles W. Resiliency in the face of disadvantage: do Hispanic cultural characteristics protect health outcomes? J Pers. 2009 Dec;77(6):1707-46. doi: 10.1111/j.1467-6494.2009.00598.x. Epub 2009 Sep 30.
- Results publication: PubMed 22059620Gallo LC, Fortmann AL, Roesch SC, Barrett-Connor E, Elder JP, de los Monteros KE, Shivpuri S, Mills PJ, Talavera GA, Matthews KA. Socioeconomic status, psychosocial resources and risk, and cardiometabolic risk in Mexican-American women. Health Psychol. 2012 May;31(3):334-42. doi: 10.1037/a0025689. Epub 2011 Nov 7.
- Results publication: PubMed 20878511Gallo LC, Jimenez JA, Shivpuri S, Espinosa de los Monteros K, Mills PJ. Domains of chronic stress, lifestyle factors, and allostatic load in middle-aged Mexican-American women. Ann Behav Med. 2011 Feb;41(1):21-31. doi: 10.1007/s12160-010-9233-1.
- Results publication: PubMed 21874364Gonzalez P, Castaneda SF, Mills PJ, Talavera GA, Elder JP, Gallo LC. Determinants of breast, cervical and colorectal cancer screening adherence in Mexican-American women. J Community Health. 2012 Apr;37(2):421-33. doi: 10.1007/s10900-011-9459-2.
- Results publication: PubMed 21554946Shivpuri S, Gallo LC, Mills PJ, Matthews KA, Elder JP, Talavera GA. Trait anger, cynical hostility and inflammation in Latinas: variations by anger type? Brain Behav Immun. 2011 Aug;25(6):1256-63. doi: 10.1016/j.bbi.2011.04.016. Epub 2011 May 1.
- Derived from this study: PubMed 22582313Gallo LC, Fortmann AL, de Los Monteros KE, Mills PJ, Barrett-Connor E, Roesch SC, Matthews KA. Individual and neighborhood socioeconomic status and inflammation in Mexican American women: what is the role of obesity? Psychosom Med. 2012 Jun;74(5):535-42. doi: 10.1097/PSY.0b013e31824f5f6d. Epub 2012 May 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda C. Gallo, PhD principal investigator
San Diego State University
John Elder, PhD principal investigator
San Diego State University
Paul Mills, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiovascular Disease, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00387166, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.