Cardiovascular DiseasesNCT00005505
Neighborhood Environments and Cardiovascular Disease
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the contributions of neighborhood environments to the distribution of cardiovascular disease (CVD) risk across different age ranges and racial/ethnic groups, using data from three ongoing cohort studies of cardiovascular disease: the Coronary Artery Disease Risk Development in Young Adults (CARDIA)… Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1997to Nov 2002
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the contributions of neighborhood environments to the distribution of cardiovascular disease (CVD) risk across different age ranges and racial/ethnic groups, using data from three ongoing cohort studies of cardiovascular disease: the Coronary Artery Disease Risk Development in Young Adults (CARDIA) Study, the Atherosclerosis Risk in Communities (ARIC) Study, and the Cardiovascular Health Study (CHS).
Read the detailed description
BACKGROUND:
There is abundant evidence of persistent differences in cardiovascular disease morbidity and mortality by socioeconomic status (SES). The determinants of SES-related differences in CVD outcomes and risk factors have not been fully established. Previous work in this area has focused predominantly on individual-level SES indicators, but recently attention has shifted to the role of neighborhood or community-level variables in shaping health outcomes, independently of individual-level SES. Several epidemiologic studies have suggested that neighborhood characteristics may influence the distribution of disease risk, but the role of both neighborhood-level and individual level SES variables in shaping individual-level outcomes and risk factors has been rarely addressed in epidemiologic studies of CVD.
DESIGN NARRATIVE:
Associations of neighborhood socioenvironmental characteristics with CVD prevalence and incidence in middle-aged and elderly populations were investigated using data from the ARIC Study and CHS. Associations of neighborhood socioenvironmental characteristics with CVD risk factors and risk factor trends in young and middle-aged adults were investigated using data from the CARDIA and ARIC studies. CARDIA and ARIC data were also used to explore the contributions of neighborhood characteristics to racial differences in CVD risk factors. Census defined areas were used as proxies for neighborhoods. Participants were linked to their census-tract and block-group of residence using their home address, and neighborhood characteristics were obtained from the 1990 U.S. Census. The three data sets were analyzed separately. After exploratory and descriptive analyses, regression models were used to investigate associations of neighborhood characteristics with the outcomes before and after controlling for individual-level SES and other relevant covariates. Appropriate statistical methods (mixed effects models) were used to account for the multilevel structure of the data (individuals nested within neighborhoods and repeated measures nested within individuals), and the potential violations of the assumption of independence of observations that might arise from it.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- 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 posted26 May 2000 (estimated)
- Study startDec 1997
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
- Sponsor type
- US National Institutes of Health
- Investigators
- Ana Diez-Roux, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005505
- Sponsor's protocol ID
- 5023
- Other IDs
- R29HL059386
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Diez-Roux AV, Link BG, Northridge ME. A multilevel analysis of income inequality and cardiovascular disease risk factors. Soc Sci Med. 2000 Mar;50(5):673-87. doi: 10.1016/s0277-9536(99)00320-2.
PubMed 10658848Morland K, Wing S, Diez Roux A, Poole C. Neighborhood characteristics associated with the location of food stores and food service places. Am J Prev Med. 2002 Jan;22(1):23-9. doi: 10.1016/s0749-3797(01)00403-2.
PubMed 11777675Diez Roux AV. Investigating neighborhood and area effects on health. Am J Public Health. 2001 Nov;91(11):1783-9. doi: 10.2105/ajph.91.11.1783.
PubMed 11684601Diez-Roux AV, Kiefe CI, Jacobs DR Jr, Haan M, Jackson SA, Nieto FJ, Paton CC, Schulz R. Area characteristics and individual-level socioeconomic position indicators in three population-based epidemiologic studies. Ann Epidemiol. 2001 Aug;11(6):395-405. doi: 10.1016/s1047-2797(01)00221-6.
PubMed 11454499Diez Roux AV, Merkin SS, Arnett D, Chambless L, Massing M, Nieto FJ, Sorlie P, Szklo M, Tyroler HA, Watson RL. Neighborhood of residence and incidence of coronary heart disease. N Engl J Med. 2001 Jul 12;345(2):99-106. doi: 10.1056/NEJM200107123450205.
PubMed 11450679Diez-Roux AV. Multilevel analysis in public health research. Annu Rev Public Health. 2000;21:171-92. doi: 10.1146/annurev.publhealth.21.1.171.
PubMed 10884951Diez Roux AV, Chambless L, Merkin SS, Arnett D, Eigenbrodt M, Nieto FJ, Szklo M, Sorlie P. Socioeconomic disadvantage and change in blood pressure associated with aging. Circulation. 2002 Aug 6;106(6):703-10. doi: 10.1161/01.cir.0000025402.84600.cd.
PubMed 12163431Diez Roux AV, Merkin SS, Hannan P, Jacobs DR, Kiefe CI. Area characteristics, individual-level socioeconomic indicators, and smoking in young adults: the coronary artery disease risk development in young adults study. Am J Epidemiol. 2003 Feb 15;157(4):315-26. doi: 10.1093/aje/kwf207.
PubMed 12578802Diez Roux AV, Jacobs DR, Kiefe CI; Coronary Artery Risk Developoment in Young Adults (CARDIA) Study. Neighborhood characteristics and components of the insulin resistance syndrome in young adults: the coronary artery risk development in young adults (CARDIA) study. Diabetes Care. 2002 Nov;25(11):1976-82. doi: 10.2337/diacare.25.11.1976.
PubMed 12401742
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neighborhood Environments and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00005505
- Acronym / sponsor ID
- 5023
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1997
- Study completion
- Nov 2002 (actual)
- First posted
- 26 May 2000 (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 investigate the contributions of neighborhood environments to the distribution of cardiovascular disease (CVD) risk across different age ranges and racial/ethnic groups, using data from three ongoing cohort studies of cardiovascular disease: the Coronary Artery Disease Risk Development in Young Adults (CARDIA) Study, the Atherosclerosis Risk in Communities (ARIC) Study, and the Cardiovascular Health Study (CHS).
Detailed description
BACKGROUND:
There is abundant evidence of persistent differences in cardiovascular disease morbidity and mortality by socioeconomic status (SES). The determinants of SES-related differences in CVD outcomes and risk factors have not been fully established. Previous work in this area has focused predominantly on individual-level SES indicators, but recently attention has shifted to the role of neighborhood or community-level variables in shaping health outcomes, independently of individual-level SES. Several epidemiologic studies have suggested that neighborhood characteristics may influence the distribution of disease risk, but the role of both neighborhood-level and individual level SES variables in shaping individual-level outcomes and risk factors has been rarely addressed in epidemiologic studies of CVD.
DESIGN NARRATIVE:
Associations of neighborhood socioenvironmental characteristics with CVD prevalence and incidence in middle-aged and elderly populations were investigated using data from the ARIC Study and CHS. Associations of neighborhood socioenvironmental characteristics with CVD risk factors and risk factor trends in young and middle-aged adults were investigated using data from the CARDIA and ARIC studies. CARDIA and ARIC data were also used to explore the contributions of neighborhood characteristics to racial differences in CVD risk factors. Census defined areas were used as proxies for neighborhoods. Participants were linked to their census-tract and block-group of residence using their home address, and neighborhood characteristics were obtained from the 1990 U.S. Census. The three data sets were analyzed separately. After exploratory and descriptive analyses, regression models were used to investigate associations of neighborhood characteristics with the outcomes before and after controlling for individual-level SES and other relevant covariates. Appropriate statistical methods (mixed effects models) were used to account for the multilevel structure of the data (individuals nested within neighborhoods and repeated measures nested within individuals), and the potential violations of the assumption of independence of observations that might arise from it.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- 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 16 Mar 2016.
- Background: PubMed 10658848Diez-Roux AV, Link BG, Northridge ME. A multilevel analysis of income inequality and cardiovascular disease risk factors. Soc Sci Med. 2000 Mar;50(5):673-87. doi: 10.1016/s0277-9536(99)00320-2.
- Background: PubMed 11777675Morland K, Wing S, Diez Roux A, Poole C. Neighborhood characteristics associated with the location of food stores and food service places. Am J Prev Med. 2002 Jan;22(1):23-9. doi: 10.1016/s0749-3797(01)00403-2.
- Background: PubMed 11684601Diez Roux AV. Investigating neighborhood and area effects on health. Am J Public Health. 2001 Nov;91(11):1783-9. doi: 10.2105/ajph.91.11.1783.
- Background: PubMed 11454499Diez-Roux AV, Kiefe CI, Jacobs DR Jr, Haan M, Jackson SA, Nieto FJ, Paton CC, Schulz R. Area characteristics and individual-level socioeconomic position indicators in three population-based epidemiologic studies. Ann Epidemiol. 2001 Aug;11(6):395-405. doi: 10.1016/s1047-2797(01)00221-6.
- Background: PubMed 11450679Diez Roux AV, Merkin SS, Arnett D, Chambless L, Massing M, Nieto FJ, Sorlie P, Szklo M, Tyroler HA, Watson RL. Neighborhood of residence and incidence of coronary heart disease. N Engl J Med. 2001 Jul 12;345(2):99-106. doi: 10.1056/NEJM200107123450205.
- Background: PubMed 10884951Diez-Roux AV. Multilevel analysis in public health research. Annu Rev Public Health. 2000;21:171-92. doi: 10.1146/annurev.publhealth.21.1.171.
- Background: PubMed 12163431Diez Roux AV, Chambless L, Merkin SS, Arnett D, Eigenbrodt M, Nieto FJ, Szklo M, Sorlie P. Socioeconomic disadvantage and change in blood pressure associated with aging. Circulation. 2002 Aug 6;106(6):703-10. doi: 10.1161/01.cir.0000025402.84600.cd.
- Background: PubMed 12578802Diez Roux AV, Merkin SS, Hannan P, Jacobs DR, Kiefe CI. Area characteristics, individual-level socioeconomic indicators, and smoking in young adults: the coronary artery disease risk development in young adults study. Am J Epidemiol. 2003 Feb 15;157(4):315-26. doi: 10.1093/aje/kwf207.
- Background: PubMed 12401742Diez Roux AV, Jacobs DR, Kiefe CI; Coronary Artery Risk Developoment in Young Adults (CARDIA) Study. Neighborhood characteristics and components of the insulin resistance syndrome in young adults: the coronary artery risk development in young adults (CARDIA) study. Diabetes Care. 2002 Nov;25(11):1976-82. doi: 10.2337/diacare.25.11.1976.
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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.
Ana Diez-Roux
Columbia University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. 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 NCT00005505, which also lists 9 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 16 Mar 2016.