DiabetesNCT01323322
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
An observational study of Diabetes and Cerebrovascular Disease, run by National Institute on Aging (NIA) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Diabetes, Cerebrovascular Disease, Age-Associated Decline
- How many people
- 3,720 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2009to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Current cancer chemotherapy or radiation therapy
- Positive COVID test at point of care testing on examination visit date.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
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.
Read the 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.
- Keywords
- Socioeconomic Status, Longitudinal Study, Health Disparities, Epidemiology, Diversity, Natural History
- Medical subject headings
- Diabetes Mellitus, Cerebrovascular Disorders, Cardiovascular 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 |
|---|---|---|
| HANDLS | A fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To disentangle the relationship between race, SES, and health outcomes.
Health Outcomes
Measured: 4 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study start1 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 3,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Maryland, Baltimore, Rensselaer Polytechnic Institute, Johns Hopkins University, Massachusetts General Hospital, University of Delaware, US Department of Housing and Urban Development
- Responsible party
- Sponsor
- Investigators
- Michele K Evans, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323322
- Sponsor's protocol ID
- 999909248
- Other IDs
- 09-AG-N248
- Status last verified
- 11 Jun 2026
- First submitted
- 24 Mar 2011
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Publications
Evans MK, Zonderman AB. Health Equity through Clinical Research - Meeting the Challenge of Inclusion. NEJM Evid. 2023 Jun;2(6):EVIDctw2300015. doi: 10.1056/EVIDctw2300015. Epub 2023 May 23.
PubMed 38320133Claudel 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.
PubMed 31572702
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
- ClinicalTrials.gov ID
- NCT01323322
- Acronym / sponsor ID
- 999909248
- Keywords
- Socioeconomic Status, Longitudinal Study, Health Disparities, Epidemiology, Diversity, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,720 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- University of Maryland, Baltimore, Rensselaer Polytechnic Institute, Johns Hopkins University, Massachusetts General Hospital, University of Delaware, US Department of Housing and Urban Development
- Study start
- 1 Jul 2009 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HANDLS | – | –A fixed cohort as an area probability sample of Baltimore City from August 2004 through November 2009. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy
- Current cancer chemotherapy or radiation therapy
- Positive COVID test at point of care testing on examination visit date.
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
To disentangle the relationship between race, SES, and health outcomes.
Time frame: 4 to 5 years
Health Outcomes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 38320133Evans MK, Zonderman AB. Health Equity through Clinical Research - Meeting the Challenge of Inclusion. NEJM Evid. 2023 Jun;2(6):EVIDctw2300015. doi: 10.1056/EVIDctw2300015. Epub 2023 May 23.
- Derived from this study: PubMed 31572702Claudel 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.
- Individual participant dataSharing planned: Undecided. There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
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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.
Michele K Evans, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cerebrovascular Disease, run by National Institute on Aging (NIA) at 1 site in United States.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
To disentangle the relationship between race, SES, and health outcomes. (time frame: 4 to 5 years). 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 NCT01323322, which also lists 2 linked publications.
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 29 Oct 2026.