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Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)

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ClinicalTrials.gov Identifier: NCT01323322
Recruitment Status : Active, not recruiting
First Posted : March 25, 2011
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
University of Maryland
Rensselaer Polytechnic Institute
Johns Hopkins University
Massachusetts General Hospital
University of Delaware
US Department of Housing and Urban Development
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

Brief Summary:

The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a multidisciplinary, community-based, prospective longitudinal epidemiologic study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. This study is unique because it will assess over a 20-year period physical parameters as well as evaluate genetic, biologic, demographic, and psychosocial parameters of African American and white participants in higher and lower SES. It also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. The domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body composition and bone quality, physical function and performance, sociodemographics, psychosocial, neighborhood environment and cardiovascular disease. Utilizing data from these study domains will facilitate understand the driving factors behind persistent black-white health disparities in overall longevity, cardiovascular disease, and cognitive decline.

HANDLS recruited a fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009 as Wave 1. HANDLS Wave 2 entitled The Association of Personality and Socioeconomic status with Health Status - An Interim Follow-up Study began in June 2006 under a separate protocol. It was designed as a follow-up telephone interview approximately 18 months after the initial examination (Wave 1) was complete. Wave 2 provided interim contact with study participants, and important interim information regarding their health. Now completed, waves 3 and 4 were the first and second follow-up examinations and participants second and third visit to our mobile Medical Research Vehicles (MRVs). The current protocol outlines Wave 5, the third follow-up examination and participants fourth visit to our mobile Medical Research Vehicles (MRVs). Planned as a follow-up after 3-4 years, Wave 5 consists of health examinations, questionnaires, a telephone dietary-recall interview, sensory assessments (visual, olfactory), health literacy assessment, skin color analysis, renal function assessments, environmental assessments and structural MRIs.


Condition or disease
Diabetes Cerebrovascular Disease Age-Associated Decline Cardiovascular Disease

Detailed Description:

The Healthy Aging in Neighborhoods of Diversity across the Life Span study (HANDLS) is a multidisciplinary, community-based, prospective longitudinal epidemiologic study examining the influences of race and socioeconomic status (SES) on the development of age-related health disparities among socioeconomically diverse African Americans and whites in Baltimore. This study investigates whether health disparities develop or persist due to differences in SES, differences in race, or their interaction. This study is unique because it will assess over a 20-year period physical parameters as well as evaluate genetic, biologic, demographic, and psychosocial parameters of African American and white participants in higher and lower SES. It also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among non-traditional research participants. The domains of the HANDLS study include: nutrition, cognition, biologic biomarkers, body composition and bone quality, physical function and performance, sociodemographics, psychosocial, neighborhood environment and cardiovascular disease. Utilizing data from these study domains will facilitate understand the driving factors behind persistent black-white health disparities in overall longevity, cardiovascular disease, and cognitive decline.

HANDLS recruited a fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009 as Wave 1. HANDLS Wave 2 entitled The Association of Personality and Socioeconomic status with Health Status - An Interim Follow-up Study began in June 2006 under a separate protocol. It was designed as a follow-up telephone interview approximately 18 months after the initial examination (Wave 1) was complete. Wave 2 provided interim contact with study participants, and important interim information regarding their health. Now completed, waves 3 and 4 were the first and second follow-up examinations and participants second and third visit to our mobile Medical Research Vehicles (MRVs). The current protocol outlines Wave 5, the third follow-up examination and participants fourth visit to our mobile Medical Research Vehicles (MRVs). Planned as a follow-up after 3-4 years, Wave 5 consists of health examinations, questionnaires, a telephone dietary-recall interview, sensory assessments (visual, olfactory), health literacy assessment, renal function assessments, environmental assessments and structural MRIs.


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Study Type : Observational
Actual Enrollment : 3720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Study Start Date : June 22, 2009

Group/Cohort
HANDLS
A fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009.



Primary Outcome Measures :
  1. To disentangle the relationship between race, SES, and health outcomes. [ Time Frame: 4 to 5 years ]
    Health Outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The baseline HANDLS sample consists of 3720 community - dwelling African American and white adults aged 30-64. Participants were drawn from 13 neighborhoods (groups of contiguous census tracts) in Baltimore City, sampling represently across a wide range of socioeconomic and income circumstances.
Criteria
  • INCLUSION CRITERIA:
  • Verified HANDLS participants (age 30-64 at baseline recruitment)
  • Able to give informed consent (or has a legal designee)
  • Must have valid picture identification

EXCLUSION CRITERIA:

  • Pregnancy (for the MRV examination visit and the HANDLS Scan sub-study a urine pregnancy test is performed with women of child bearing potential during the medical screening prior to any testing or procedures. If positive, participant will not be eligible for the MRV examination visit until they are no longer pregnant. Participants with a positive pregnancy test will be invited to return for the MRV examination visit and/or the HANDLS Scan once pregnancy is resolved (pregnancy testing is repeated at each encounter, if indicated). The Diabetes sub-study home visit protocol does not pose increased risk so pregnancy status is not required or obtained)
  • Current cancer chemotherapy or radiation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323322


Locations
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United States, Maryland
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
University of Maryland at Baltimore/MPRC
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
National Institute on Aging (NIA)
University of Maryland
Rensselaer Polytechnic Institute
Johns Hopkins University
Massachusetts General Hospital
University of Delaware
US Department of Housing and Urban Development
Investigators
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Principal Investigator: Michele K Evans, M.D. National Institute on Aging (NIA)

Publications:
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Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT01323322     History of Changes
Other Study ID Numbers: 999909248
09-AG-N248
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: December 27, 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):
Socioeconomic Status
Longitudinal Study
Health Disparities
Epidemiology
Diversity

Additional relevant MeSH terms:
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Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases