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

June 16, 2026 updated by: National Institute on Aging (NIA)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • National Institute of Aging, Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 64 years (Adult)

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.

Description

  • INCLUSION CRITERIA:
  • Verified HANDLS participants (age 30-64 at baseline recruitment)
  • Able to give informed consent (or have a legal designee); and
  • Must have valid picture identification.

EXCLUSION CRITERIA:

  • Pregnancy
  • Current cancer chemotherapy or radiation therapy
  • Positive COVID test at point of care testing on examination visit date.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
HANDLS
A fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To disentangle the relationship between race, SES, and health outcomes.
Time Frame: 4 to 5 years
Health Outcomes
4 to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute on Aging (NIA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Massachusetts General Hospital
University of Maryland, Baltimore
University of Delaware
Rensselaer Polytechnic Institute
US Department of Housing and Urban Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michele K Evans, M.D., National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 11, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 999909248
  • 09-AG-N248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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