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

• ClinicalTrials.gov Identifier: NCT01323322
• Recruitment Status: Active, not recruiting
• First Posted: March 25, 2011
• Last Update Posted: March 27, 2023
• Sponsor: National Institute on Aging (NIA)
• Collaborators: University of Maryland, Baltimore; 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) )

Study Description

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 (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. Planned as a 20-year longitudinal study, 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. HANDLS also employs novel research tools, mobile medical research vehicles, in hopes of improving participation rates and retention among nontraditional 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 inperson examinations with wave 7 in which we will prioritize contacting participants who were not seen in wave 5.

Study Design

• 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)
• Actual Study Start Date: July 1, 2009

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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 representatively 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

Contacts and Locations

Locations

United States, Maryland

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

National Institute on Aging (NIA)

University of Maryland, Baltimore

Rensselaer Polytechnic Institute

Johns Hopkins University

Massachusetts General Hospital

University of Delaware

US Department of Housing and Urban Development

Investigators

• Principal Investigator: Michele K Evans, M.D.; National Institute on Aging (NIA)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Claudel SE, Shiroma EJ, Harris TB, Mode NA, Ahuja C, Zonderman AB, Evans MK, Powell-Wiley TM. Cross-Sectional Associations of Neighborhood Perception, Physical Activity, and Sedentary Time in Community-Dwelling, Socioeconomically Diverse Adults. Front Public Health. 2019 Sep 13;7:256. doi: 10.3389/fpubh.2019.00256. eCollection 2019.

• Responsible Party: National Institute on Aging (NIA)
• ClinicalTrials.gov Identifier: NCT01323322
• Other Study ID Numbers: 999909248; 09-AG-N248
• First Posted: March 25, 2011
• Last Update Posted: March 27, 2023
• Last Verified: February 3, 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: .There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.

• 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; Natural History

Additional relevant MeSH terms:

Cerebrovascular Disorders; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases