Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01323322 |
| Other study ID # |
999909248 |
| Secondary ID |
09-AG-N248 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2009 |
Study information
| Verified date |
April 2, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study is an
interdisciplinary, 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. HANDLS is unique because it assesses physical
parameters as well as evaluating genetic, biologic, demographic, and psychosocial parameters
of African American and white participants over a wide range of socioeconomic statuses,
longitudinally. HANDLS 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, psychology,
genomics, neighborhood environment and cardiovascular disease. Utilizing data from these
study domains will facilitate an understanding of selected underlying factors of 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, 4 and 5 were follow-up examinations visits to our mobile Medical
Research Vehicles (MRVs). In September 2020, HANDLS initiated wave 6; telephone interviews
and limited in-person visits as a COVID-centric protocol. The current protocol outlines Wave
7, the fourth follow-up examination and the participants fifth visit to our mobile Medical
Research Vehicles (MRVs). Planned as a follow-up after 3-4 years, Wave 7 consists of health
examinations, questionnaires, sensory assessments (visual and olfactory), health literacy
assessment, renal function assessments, environmental assessments, and for a sub-set of
participants; structural MRIs, a personality inventory and an examination of sleep and
cognition under separate protocols. HANDLS will resume in-person examinations with wave 7 in
which we will prioritize contacting participants who were not seen in wave 5.
Description:
The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study is an
interdisciplinary, 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. HANDLS is unique because it assesses physical
parameters as well as evaluating genetic, biologic, demographic, and psychosocial parameters
of African American and white participants over a wide range of socioeconomic statuses,
longitudinally. HANDLS 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, psychology,
genomics, neighborhood environment and cardiovascular disease. Utilizing data from these
study domains will facilitate an understanding of selected underlying factors of 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, 4 and 5 were follow-up examinations visits to our mobile Medical
Research Vehicles (MRVs). In September 2020, HANDLS initiated wave 6; telephone interviews
and limited in-person visits as a COVID-centric protocol. The current protocol outlines Wave
7, the fourth follow-up examination and the participants fifth visit to our mobile Medical
Research Vehicles (MRVs). Planned as a follow-up after 3-4 years, Wave 7 consists of health
examinations, questionnaires, sensory assessments (visual and olfactory), health literacy
assessment, renal function assessments, environmental assessments, and for a sub-set of
participants; structural MRIs, a personality inventory and an examination of sleep and
cognition under separate protocols. HANDLS will resume in-person examinations with wave 7 in
which we will prioritize contacting participants who were not seen in wave 5.
