Cardiovascular DiseasesNCT00031252
Neighborhood-Level Influences on All-Cause Mortality
An observational study of Cardiovascular Diseases and Heart Diseases, run by Stanford University.
Trial summary
To test the independent and interrelated effects of the neighborhood social environment, the neighborhood physical environment, and individual risk factors in predicting all-cause and cardiovascular disease mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To test the independent and interrelated effects of the neighborhood social environment, the neighborhood physical environment, and individual risk factors in predicting all-cause and cardiovascular disease mortality.
Read the detailed description
BACKGROUND:
The study examines how social and physical features of neighborhoods interact with individual factors to influence disparities in health, an important but understudied area of research. This project will create a rich new database where individuals' socioeconomic status (SES) and health indicators are linked with characteristics of their specific neighborhoods and their subsequent mortality. Thus, it builds on an important exiting data base to create a contextual-level database with information about mortality.
DESIGN NARRATIVE:
Few studies have examined how social and physical features of neighborhoods interact with individual factors, e.g., health behaviors and socioeconomic status (SES), to influence disparities in health. The investigators propose to test the independent and interrelated effects of the neighborhood social environment (e.g., neighborhood SES, social disorganization, Hispanic concentration, crime rates), neighborhood physical environment (e.g., housing conditions, availability of goods and services such as licensed alcohol distributors, fast food restaurants, grocery stores, gun shops, educational resources, recreational facilities, banking/lending institutions), and individual risk factors in predicting all-cause and cardiovascular disease (CVD) mortality in women and men. They will conduct a prospective mortality follow-up study of 8,847 white (non-Hispanic) and Hispanic women and men who participated in the Stanford Heart Disease Prevention Program (SHDPP), also referred to as the Stanford Five-City Project. This population-based CVD study included a random sample of women and men aged 25-74 who participated in one of five cross-sectional surveys (1979-1990) and were from four socioeconomically diverse California cities. The SHDPP is recognized for its comprehensive and well-standardized survey and physiologic measures that include SES (education, income, occupation), CVD risk factors (e.g., smoking, high cholesterol and saturated fat), psychosocial factors, and other health-related measures. The investigators propose to match survey data to death records for all-cause and CVD mortality endpoints, and link geocoded addresses to census data and archival data for measures of the neighborhood social and physical environment. This work would create a new database where individuals' SES and health indicators are linked with characteristics of their specific neighborhoods. Based on their empirical findings, they will identity neighborhoods currently at high and low risk for mortality, then conduct focus groups and map neighborhood environments (e.g., social, physical, and service features) to create a geographic information system (GIS). These two activities will hopefully extend their empirical findings, generate new hypotheses, and guide the development of their Community Outreach and Education Program (COEP). The COEP will build on their collaborative partnerships with members of the study cities, health advocates, and health agencies that serve low SES and medically under served populations. With the involvement of these partners, they will integrate their empirical findings with knowledge from existing studies and disseminate results via the Internet, media, targeted mailings, and programs offered by the California State and local county health departments in the four study cities.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2002 (estimated)
- Study startJan 2001
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford 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
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Marilyn Winkleby, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031252
- Sponsor's protocol ID
- 995
- Other IDs
- R01HL067731
- Status last verified
- Jun 2013
- First submitted
- 27 Feb 2002
- Last updated
- 26 Jun 2013
- Results posted
- No
Publications
Cubbin C, Hadden WC, Winkleby MA. Neighborhood context and cardiovascular disease risk factors: the contribution of material deprivation. Ethn Dis. 2001 Fall;11(4):687-700.
PubMed 11763293Winkleby MA, Cubbin C. Influence of individual and neighbourhood socioeconomic status on mortality among black, Mexican-American, and white women and men in the United States. J Epidemiol Community Health. 2003 Jun;57(6):444-52. doi: 10.1136/jech.57.6.444.
PubMed 12775792Chuang YC, Cubbin C, Ahn D, Winkleby MA. Effects of neighbourhood socioeconomic status and convenience store concentration on individual level smoking. J Epidemiol Community Health. 2005 Jul;59(7):568-73. doi: 10.1136/jech.2004.029041.
PubMed 15965140Cubbin C, Winkleby MA. Protective and harmful effects of neighborhood-level deprivation on individual-level health knowledge, behavior changes, and risk of coronary heart disease. Am J Epidemiol. 2005 Sep 15;162(6):559-68. doi: 10.1093/aje/kwi250. Epub 2005 Aug 10.
PubMed 16093286
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neighborhood-Level Influences on All-Cause Mortality
- ClinicalTrials.gov ID
- NCT00031252
- Acronym / sponsor ID
- 995
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Feb 2002 (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.
To test the independent and interrelated effects of the neighborhood social environment, the neighborhood physical environment, and individual risk factors in predicting all-cause and cardiovascular disease mortality.
Detailed description
BACKGROUND:
The study examines how social and physical features of neighborhoods interact with individual factors to influence disparities in health, an important but understudied area of research. This project will create a rich new database where individuals' socioeconomic status (SES) and health indicators are linked with characteristics of their specific neighborhoods and their subsequent mortality. Thus, it builds on an important exiting data base to create a contextual-level database with information about mortality.
DESIGN NARRATIVE:
Few studies have examined how social and physical features of neighborhoods interact with individual factors, e.g., health behaviors and socioeconomic status (SES), to influence disparities in health. The investigators propose to test the independent and interrelated effects of the neighborhood social environment (e.g., neighborhood SES, social disorganization, Hispanic concentration, crime rates), neighborhood physical environment (e.g., housing conditions, availability of goods and services such as licensed alcohol distributors, fast food restaurants, grocery stores, gun shops, educational resources, recreational facilities, banking/lending institutions), and individual risk factors in predicting all-cause and cardiovascular disease (CVD) mortality in women and men. They will conduct a prospective mortality follow-up study of 8,847 white (non-Hispanic) and Hispanic women and men who participated in the Stanford Heart Disease Prevention Program (SHDPP), also referred to as the Stanford Five-City Project. This population-based CVD study included a random sample of women and men aged 25-74 who participated in one of five cross-sectional surveys (1979-1990) and were from four socioeconomically diverse California cities. The SHDPP is recognized for its comprehensive and well-standardized survey and physiologic measures that include SES (education, income, occupation), CVD risk factors (e.g., smoking, high cholesterol and saturated fat), psychosocial factors, and other health-related measures. The investigators propose to match survey data to death records for all-cause and CVD mortality endpoints, and link geocoded addresses to census data and archival data for measures of the neighborhood social and physical environment. This work would create a new database where individuals' SES and health indicators are linked with characteristics of their specific neighborhoods. Based on their empirical findings, they will identity neighborhoods currently at high and low risk for mortality, then conduct focus groups and map neighborhood environments (e.g., social, physical, and service features) to create a geographic information system (GIS). These two activities will hopefully extend their empirical findings, generate new hypotheses, and guide the development of their Community Outreach and Education Program (COEP). The COEP will build on their collaborative partnerships with members of the study cities, health advocates, and health agencies that serve low SES and medically under served populations. With the involvement of these partners, they will integrate their empirical findings with knowledge from existing studies and disseminate results via the Internet, media, targeted mailings, and programs offered by the California State and local county health departments in the four study cities.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 26 Jun 2013.
- Background: PubMed 11763293Cubbin C, Hadden WC, Winkleby MA. Neighborhood context and cardiovascular disease risk factors: the contribution of material deprivation. Ethn Dis. 2001 Fall;11(4):687-700.
- Background: PubMed 12775792Winkleby MA, Cubbin C. Influence of individual and neighbourhood socioeconomic status on mortality among black, Mexican-American, and white women and men in the United States. J Epidemiol Community Health. 2003 Jun;57(6):444-52. doi: 10.1136/jech.57.6.444.
- Background: PubMed 15965140Chuang YC, Cubbin C, Ahn D, Winkleby MA. Effects of neighbourhood socioeconomic status and convenience store concentration on individual level smoking. J Epidemiol Community Health. 2005 Jul;59(7):568-73. doi: 10.1136/jech.2004.029041.
- Background: PubMed 16093286Cubbin C, Winkleby MA. Protective and harmful effects of neighborhood-level deprivation on individual-level health knowledge, behavior changes, and risk of coronary heart disease. Am J Epidemiol. 2005 Sep 15;162(6):559-68. doi: 10.1093/aje/kwi250. Epub 2005 Aug 10.
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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.
Marilyn Winkleby
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Stanford University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00031252, which also lists 4 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 26 Jun 2013.