Cardiovascular DiseasesNCT00094211
Understanding the Impact of Neighborhood Type on Physical Activity in Older Adults
An observational study of Cardiovascular Diseases and Heart Diseases, run by Stanford University at 3 sites in 2 countries.
Trial summary
The purpose of this study is to investigate whether seniors living in neighborhoods that are conducive to walking are more physically active than those living in neighborhoods that are less conducive to walking. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- 896 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2004to Jun 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Residents of selected block groups in King County, WA and the Baltimore region.
Who may be able to join
- Currently living in an apartment, condo, house, or assisted living facility
- Able to walk more than 10 feet at a time
- Able to speak and read English
- Able to complete study surveys (with assistance if necessary)
Who cannot join
- Not currently living in one of the areas in which the study will take place
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
San Diego State University
San Diego, California, 92103
Stanford University School of Medicine
Stanford, California, 94305
Canada1 site
University of British Columbia-Vancouver
Vancouver, British Columbia
About this study
Official title: Neighborhood Impact on Physical Activity in Older Adults
The purpose of this study is to investigate whether seniors living in neighborhoods that are conducive to walking are more physically active than those living in neighborhoods that are less conducive to walking.
Read the detailed description
BACKGROUND:
Despite the recognized benefits of regular physical activity for older adults, people over the age of 65 remain among the most inactive groups of the U.S. population. Efforts to understand the factors influencing physical activity in this important group have been limited primarily to demographic and psychosocial domains. The importance of the neighborhood environment in influencing a host of health, behavioral, and psychosocial outcomes has been recognized. However, to date, no systematic investigation of the relationship between objective and subjective environmental factors and objectively measured physical activity levels among older adults has been undertaken.
DESIGN NARRATIVE:
This observational study will investigate whether seniors living in neighborhoods conducive to walking are more physically active, after adjusting for socioeconomic status (SES), than those living in neighborhoods less conducive to walking or other forms of physical activity for transportation or recreational purposes. Additional questions of interest concern the moderating effects of physical function and the proportion of seniors living nearby on the relationship between environment and physical activity. The study will take advantage of the sampling, recruitment, and data collection methods of an ongoing NIH-funded research project aimed at integrating public health and urban planning frameworks in studying the impacts of environmental factors on physical activity levels in younger adults. Population-based sampling methods will be used to recruit adults over 65 years of age who are living in more walkable versus less walkable neighborhoods of varying SES levels. Participants will be recruited from Seattle, Washington (n = 600) and Baltimore, Maryland (n = 600). In addition to objectively measured physical environment (using geographic information systems {GIS}) and physical activity levels (using accelerometry), self-reported neighborhood environment, physical activity, and quality of life variables of particular relevance to older adults will be assessed twice during a 12-month period.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
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 |
|---|---|---|
| Low Walkability/Low Income | Participants reside in a low walkability, low income neighborhood | |
| Low Walkability/High Income | Participants reside in a low walkability, high income neighborhood | |
| High Walkability/Low Income | Participants reside in a high walkability, low income neighborhood | |
| High Walkability/High Income | Participants reside in a high walkability, high income neighborhood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Environment Factors Using Geographic Information Systems [GIS]
Physical environment factors measured using GIS-derived measures of street connectivity, residential density, and mixed land use in participant block groups and a network buffer around each participant's home. A walkability index was created for a 500 meter street network buffer around participant homes. The walkability index was calculated for each census block group in the regions by summing the z-scores of four macro built environment measures: 1) net residential density, 2) intersection density, 3) retail floor to land area ratio (FAR), and 4) mixed use. A higher scores indicates higher walkability. The minimum value is -4.08 and the maximum value is 12.5.
Measured: at two time points, 6 months apart, which were averaged
Community Healthy Activities Model Program for Seniors (CHAMPS) Self-reported Walking for Errands
A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable. (See Stewart AL, Mills KM, King AC, et al. CHAMPS Physical Activity Questionnaire for Older Adults: Outcomes for Interventions. Med Sci Sports Exerc, 33:7, 1126-1141, 2001.)
Measured: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
Accelerometer Measured Physical Activity
Ambulatory assessment of moderate-to-vigorous physical activity using a validated Actigraph accelerometer. Participants were instructed to wear the accelerometer during waking hours for seven days at each of the two measurement points. The accelerometer was placed over the right hip. Data were cleaned and scored using MeterPlus version 4.0 software.
Measured: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
Neighborhood Environment for Walkability Survey (NEWS) - Walking and Cycling Facilities in Neighborhood
The scale is walking/cycling facilities which is a mean of 5 items. The minimum value is 1 and the maximum value is 4. Higher scores indicate an environment that is supportive of walking and cycling which is a better outcome.
Measured: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
Neighborhood Environment for Walkability Survey (NEWS) - Land Use Mix Access
The scale is land use mix access which is a mean of 7 items. The minimum value is 1 and the maximum value is 4. Higher scores indicate easier access to services which is indicative of a high walkability environment (i.e., a better outcome).
Measured: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2004 (estimated)
- Study startSep 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Abby C King, Stanford University
- Investigators
- Abby King, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094211
- Sponsor's protocol ID
- 1275
- Other IDs
- R01HL077141
- Status last verified
- May 2019
- First submitted
- 15 Oct 2004
- Last updated
- 28 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.
PubMed 11445760
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neighborhood Impact on Physical Activity in Older Adults
- ClinicalTrials.gov ID
- NCT00094211
- Acronym / sponsor ID
- 1275
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Oct 2004 (estimated)
- Results
- Posted 28 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether seniors living in neighborhoods that are conducive to walking are more physically active than those living in neighborhoods that are less conducive to walking.
Detailed description
BACKGROUND:
Despite the recognized benefits of regular physical activity for older adults, people over the age of 65 remain among the most inactive groups of the U.S. population. Efforts to understand the factors influencing physical activity in this important group have been limited primarily to demographic and psychosocial domains. The importance of the neighborhood environment in influencing a host of health, behavioral, and psychosocial outcomes has been recognized. However, to date, no systematic investigation of the relationship between objective and subjective environmental factors and objectively measured physical activity levels among older adults has been undertaken.
DESIGN NARRATIVE:
This observational study will investigate whether seniors living in neighborhoods conducive to walking are more physically active, after adjusting for socioeconomic status (SES), than those living in neighborhoods less conducive to walking or other forms of physical activity for transportation or recreational purposes. Additional questions of interest concern the moderating effects of physical function and the proportion of seniors living nearby on the relationship between environment and physical activity. The study will take advantage of the sampling, recruitment, and data collection methods of an ongoing NIH-funded research project aimed at integrating public health and urban planning frameworks in studying the impacts of environmental factors on physical activity levels in younger adults. Population-based sampling methods will be used to recruit adults over 65 years of age who are living in more walkable versus less walkable neighborhoods of varying SES levels. Participants will be recruited from Seattle, Washington (n = 600) and Baltimore, Maryland (n = 600). In addition to objectively measured physical environment (using geographic information systems {GIS}) and physical activity levels (using accelerometry), self-reported neighborhood environment, physical activity, and quality of life variables of particular relevance to older adults will be assessed twice during a 12-month period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Walkability/Low Income | – | –Participants reside in a low walkability, low income neighborhood |
| Low Walkability/High Income | – | –Participants reside in a low walkability, high income neighborhood |
| High Walkability/Low Income | – | –Participants reside in a high walkability, low income neighborhood |
| High Walkability/High Income | – | –Participants reside in a high walkability, high income neighborhood |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Residents of selected block groups in King County, WA and the Baltimore region.
Key inclusion criteria (4 listed)
- Currently living in an apartment, condo, house, or assisted living facility
- Able to walk more than 10 feet at a time
- Able to speak and read English
- Able to complete study surveys (with assistance if necessary)
Key exclusion criteria (1 listed)
- Not currently living in one of the areas in which the study will take place
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
Physical Environment Factors Using Geographic Information Systems [GIS]
Time frame: at two time points, 6 months apart, which were averaged
Physical environment factors measured using GIS-derived measures of street connectivity, residential density, and mixed land use in participant block groups and a network buffer around each participant's home. A walkability index was created for a 500 meter street network buffer around participant homes. The walkability index was calculated for each census block group in the regions by summing the z-scores of four macro built environment measures: 1) net residential density, 2) intersection density, 3) retail floor to land area ratio (FAR), and 4) mixed use. A higher scores indicates higher walkability. The minimum value is -4.08 and the maximum value is 12.5.
Community Healthy Activities Model Program for Seniors (CHAMPS) Self-reported Walking for Errands
Time frame: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
A self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period. Self-reported walking for errands is one physical activity item assessed. The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value is 0 and the maximal value is variable. (See Stewart AL, Mills KM, King AC, et al. CHAMPS Physical Activity Questionnaire for Older Adults: Outcomes for Interventions. Med Sci Sports Exerc, 33:7, 1126-1141, 2001.)
Accelerometer Measured Physical Activity
Time frame: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
Ambulatory assessment of moderate-to-vigorous physical activity using a validated Actigraph accelerometer. Participants were instructed to wear the accelerometer during waking hours for seven days at each of the two measurement points. The accelerometer was placed over the right hip. Data were cleaned and scored using MeterPlus version 4.0 software.
Neighborhood Environment for Walkability Survey (NEWS) - Walking and Cycling Facilities in Neighborhood
Time frame: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
The scale is walking/cycling facilities which is a mean of 5 items. The minimum value is 1 and the maximum value is 4. Higher scores indicate an environment that is supportive of walking and cycling which is a better outcome.
Neighborhood Environment for Walkability Survey (NEWS) - Land Use Mix Access
Time frame: Assessment at baseline and 6 months, with the data across these two time points averaged to increase outcome stability.
The scale is land use mix access which is a mean of 7 items. The minimum value is 1 and the maximum value is 4. Higher scores indicate easier access to services which is indicative of a high walkability environment (i.e., a better outcome).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 11445760Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.
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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.
Abby King principal investigator
Stanford University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Stanford University at 3 sites in 2 countries.
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 4 inclusion and 1 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Environment Factors Using Geographic Information Systems [GIS] (time frame: at two time points, 6 months apart, which were averaged). The study lists 5 primary outcomes in all. 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 NCT00094211, which also lists 1 linked publication.
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 28 May 2019.