Cardiovascular DiseasesNCT00361673
Evaluating the Effect of Neighborhood Environments on Cardiovascular Risk Factors
An observational study of Cardiovascular Diseases, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Cardiovascular disease (CVD) is one of the main causes of death in the United States. Research has shown that individuals who maintain an active lifestyle are less likely to develop CVD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 1,140 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to May 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of one of the following five neighborhoods in the Greater Stapleton Community: Northeast Park Hill, Greater Park Hill, East Montclair, Stapleton, or Original Aurora
Who may be able to join
- Live in one of the following five neighborhoods in the Greater Stapleton Community: Northeast Park Hill, Greater Park Hill, East Montclair, Stapleton, or Original Aurora
- Speak either English or Spanish
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Colorado Denver
Denver, Colorado, 80217
About this study
Official title: Reducing CVD (Cardiovascular Disease) Risk and Health Disparities Through Active Living Communities
Cardiovascular disease (CVD) is one of the main causes of death in the United States. Research has shown that individuals who maintain an active lifestyle are less likely to develop CVD. This study will examine how neighborhood environments influence CVD risk factors of residents in and around the Stapleton community of Denver, Colorado.
Read the detailed description
CVD is a major health problem in the United States. Individuals who live in an environment in which it is difficult to maintain an active lifestyle may be more at risk for developing CVD. Because of an increased interest in healthy living, urban planners and architects are now developing neighborhoods that are designed to encourage physical activity. Parks, walking and bicycle trails, wider sidewalks, and community recreation facilities are examples of amenities that are being included in these neighborhoods. By incorporating these enhancements, the Stapleton community in Denver, Colorado has been redeveloped as a more active living environment. The purpose of this study is to determine the effect of the neighborhood environment on the cardiovascular health of residents in five racially, ethnically, and socioeconomically diverse neighborhoods in or near the Stapleton community.
In Years 1 and 2 of this study, 200 households from each of the five neighborhoods will be randomly chosen to complete a survey regarding their cardiovascular health, physical activity level, and use and perception of their neighborhood environment and facilities, for a total of 1,000 surveys. Interviews and focus groups with members of the community will also be used to gather information. Additionally, a neighborhood council composed of community members will be formed to study disparities among the five neighborhoods in their use of their neighborhood environments, their physical activity levels, and their cardiovascular risk factors. In Year 2, study researchers will analyze the collected data and distribute the findings within the communities. They will also begin testing culturally and community relevant programs aimed at reducing CVD risk factors.
- Conditions
- Cardiovascular Diseases
- Keywords
- Health Disparities, Built Environments
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the neighborhood environment on the cardiovascular health of residents
Measured: Measured during Years 1 and 2 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 1,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Debbi S. Main, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361673
- Sponsor's protocol ID
- 06-0264
- Other IDs
- R21HL083866, R21HL083866-01
- Status last verified
- Dec 2013
- First submitted
- 4 Aug 2006
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing CVD (Cardiovascular Disease) Risk and Health Disparities Through Active Living Communities
- ClinicalTrials.gov ID
- NCT00361673
- Acronym / sponsor ID
- 06-0264
- Conditions
- Cardiovascular Diseases
- Keywords
- Health Disparities, Built Environments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,140 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Aug 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 one of the main causes of death in the United States. Research has shown that individuals who maintain an active lifestyle are less likely to develop CVD. This study will examine how neighborhood environments influence CVD risk factors of residents in and around the Stapleton community of Denver, Colorado.
Detailed description
CVD is a major health problem in the United States. Individuals who live in an environment in which it is difficult to maintain an active lifestyle may be more at risk for developing CVD. Because of an increased interest in healthy living, urban planners and architects are now developing neighborhoods that are designed to encourage physical activity. Parks, walking and bicycle trails, wider sidewalks, and community recreation facilities are examples of amenities that are being included in these neighborhoods. By incorporating these enhancements, the Stapleton community in Denver, Colorado has been redeveloped as a more active living environment. The purpose of this study is to determine the effect of the neighborhood environment on the cardiovascular health of residents in five racially, ethnically, and socioeconomically diverse neighborhoods in or near the Stapleton community.
In Years 1 and 2 of this study, 200 households from each of the five neighborhoods will be randomly chosen to complete a survey regarding their cardiovascular health, physical activity level, and use and perception of their neighborhood environment and facilities, for a total of 1,000 surveys. Interviews and focus groups with members of the community will also be used to gather information. Additionally, a neighborhood council composed of community members will be formed to study disparities among the five neighborhoods in their use of their neighborhood environments, their physical activity levels, and their cardiovascular risk factors. In Year 2, study researchers will analyze the collected data and distribute the findings within the communities. They will also begin testing culturally and community relevant programs aimed at reducing CVD risk factors.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of one of the following five neighborhoods in the Greater Stapleton Community: Northeast Park Hill, Greater Park Hill, East Montclair, Stapleton, or Original Aurora
Key inclusion criteria (2 listed)
- Live in one of the following five neighborhoods in the Greater Stapleton Community: Northeast Park Hill, Greater Park Hill, East Montclair, Stapleton, or Original Aurora
- Speak either English or Spanish
Key exclusion criteria (0 listed)
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
Effect of the neighborhood environment on the cardiovascular health of residents
Time frame: Measured during Years 1 and 2 of the study
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 25 Dec 2013.
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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.
Debbi S. Main, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Colorado, Denver at 2 sites 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 2 inclusion and 0 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 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effect of the neighborhood environment on the cardiovascular health of residents (time frame: Measured during Years 1 and 2 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Dec 2013.