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Active, not recruitingNCT07180147ALOHAUpdated Mar 9, 2026

Arlington Longitudinal Optimal Healthy Aging Study (ALOHA)

An observational study in Alzheimer Disease (AD), Cardio Vascular Disease and Mild Cognitive Impairment (MCI), sponsored by Marymount University. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Marymount University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
50 Years and older
Sex
All
01

Study summary

The Arlington Longitudinal Optimal Healthy Aging (ALOHA) Study is a community-based research project led by the Marymount University Center for Optimal Aging (MCOA). The study is designed to help older adults in the Washington, D.C., Maryland, and Virginia (DMV) area maintain independence, mobility, wellbeing and brain health as they age.

Adults aged 50 years and older will receive a comprehensive health assessment at the study site, Center for Optimal Aging- ALOHA Lab at Marymount University (MU) Ballston Campus in Arlington, Virginia. The assessment includes physical and cognitive testing, health and medical history, lifestyle surveys, and biometric measures such as blood pressure, grip strength, body composition by the InBody system, balance and gait speed. Participants will receive their results in a personalized "Health Passport," which summarizes findings and provides tailored recommendations to help manage modifiable health risk factors-such as those linked to Alzheimer's disease, cardiovascular disease, frailty syndrome, and depression.

Participants will return annually for up to 5 years to repeat assessments and receive updated health and wellness recommendations. The study will track changes in health over time and explore the impact of the Health Passport on health behaviors, functional independence, and quality of life. ALOHA will also evaluate the cultural appropriateness of the Health Passport for diverse populations in Northern Virginia.

The program incorporates an interprofessional research model, engaging researchers from multiple health professions to work alongside older adults, supporting both participants' wellness and optimal aging.

Read the detailed description

The Arlington Longitudinal Optimal Healthy Aging (ALOHA) Study is an interdisciplinary, mixed-method, longitudinal research program aimed at identifying, tracking, and managing modifiable health risk factors that influence optimal aging. The study serves community-dwelling adults aged 50 and older living in the DMV region, with initial recruitment focused on healthy individuals without significant cognitive impairment or terminal illness.

The ALOHA framework combines comprehensive baseline and follow-up health assessments with personalized wellness guidance. At enrollment, participants undergo:

  1. Physical health evaluations (vital signs, body composition via bioimpedance, cardiovascular function via arteriography, mobility and endurance tests, grip strength, flexibility, balance)
  2. Cognitive assessments (Montreal Cognitive Assessment, Central Nervous System [CNS] Vital Signs, Wechsler Memory and Intelligence scales, Quality of Life in Neurological Disorders [Neuro-QOL] Cognitive Function survey)
  3. Lifestyle and psychosocial surveys (physical activity, diet quality using the MIND diet score, depression screening via the Center for Epidemiologic Studies Depression Scale [CES-D], social determinants of health, oral health, self-efficacy, quality of life)

Findings are compiled into a tailored, participant-specific, "Health Passport," which summarizes results in accessible language and offers practical, evidence-based recommendations for reducing disease risk, improving physical and cognitive function, and promoting overall wellness.

Participants return annually for up to five years to repeat assessments, receive an updated Health Passport consultation, and complete follow-up surveys regarding adherence, satisfaction, and changes in health status. The longitudinal design allows researchers to examine health trajectories, the effectiveness of early prevention strategies, and the relationship between modifiable risk factors and outcomes such as functional independence and cognitive decline.

Primary study aims:

  1. Identify and track the prevalence of modifiable risk factors for Alzheimer's disease, cardiovascular disease, frailty, and depression.
  2. Provide tailored recommendations to support participant-driven health improvement and evaluate adherence to Health Passport guidance.
  3. Engage older adults and university students in an intergenerational, interprofessional health promotion research model.

The study emphasizes cultural inclusivity, particularly for Northern Virginia's racially and ethnically diverse populations. Spanish-language materials and validated translated assessments are incorporated to support Hispanic/Latino participants.

By integrating clinical, behavioral, and community health approaches, the ALOHA study aims to contribute new evidence on preventive aging strategies, refine the Health Passport model, and expand its use to other communities and academic centers.

02

Conditions studied

  • Alzheimer Disease (AD)
  • Cardio Vascular Disease
  • Mild Cognitive Impairment (MCI)
  • Frailty Syndrome
  • Disability Physical
  • Hypertension
  • Metabolic Syndrome (MetS)
  • Healthy Aging
  • Obesity &Amp; Overweight

Keywords

  • Optimal aging
  • dementia risk factors
  • Cardiovascular Health
  • Healthy Aging
  • Alzheimer Disease Prevention
  • Lifestyle Intervention
  • Dementia Risk Reduction
  • Cognitive Aging
  • Brain Health
  • Falls Prevention
  • Physical Function
  • Functional Independence
  • Frailty Prevention
  • Modifiable Risk Facators
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Marymount University is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Community-dwelling adults aged 50 years and older living in the Washington, D.C., Maryland, and Virginia metropolitan area. Participants are generally healthy or have manageable chronic conditions and are able to complete physical, cognitive, and psychosocial assessments. Recruitment will emphasize diversity, including racial/ethnic minority groups and individuals from underserved communities, with study materials available in English and Spanish.

Inclusion criteria

  • Age 50 years or older at time of enrollment
  • Residing in the Washington, District of Columbia (DC)., Maryland, or Virginia metropolitan areas
  • Community-dwelling (living independently or with minimal assistance)
  • Able to participate in physical and cognitive assessments
  • Able to provide informed consent
  • Willing to return for annual follow-up assessments for up to 5 years

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of dementia or significant cognitive impairment that prevents informed consent or participation in assessments
  • Severe physical disability or medical condition that precludes participation in study assessments (e.g., unstable cardiac condition, severe mobility limitation)
  • Current diagnosis of a terminal illness with life expectancy less than 12 months
  • Residing in a long-term care facility or nursing home at time of enrollment
  • Inability to communicate in English or Spanish (study materials available in these languages only)
  • Participation in another interventional trial that could confound study results
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • ALOHA Health Passport Cohort

    Community-dwelling adults aged 50 and older who receive a comprehensive baseline and annual health assessment at the Marymount University Center for Optimal Aging. Assessments include physical, cognitive, and psychosocial measures. Results are compiled into a personalized "Health Passport" with tailored recommendations for managing modifiable health risk factors. Participants return annually for up to 5 years to monitor health changes, update recommendations, and complete follow-up surveys on adherence and outcomes.

06

What researchers measure

Primary outcomes

  1. Change in adherence to Health Passport recommendations-Physical/Cardiovascular Health (HPAI-PC)

    Health Passport Adherence Index (HPAI) Physical/Cardiovascular health; study-specific index. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  2. Change in adherence to Health Passport recommendations-Cognitive, Sleep, and Mental Health (HPAI-CSM)

    Health Passport Adherence Index (HPAI) for Cognitive, Sleep and Mental Health. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

Secondary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) score

    The Montreal Cognitive Assessment (MoCA) is a 30-point scale used to assess global cognitive function, including memory, attention, language, and executive function. Higher scores indicate better cognitive performance.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  2. Change in static balance (Four-Stage Balance Test)

    Total seconds successfully held across 4 stances (0-40 s); higher = better. Unit: seconds.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  3. Change in adherence to Health Passport recommendations-Diet and Oral Health (HPAI-DO)

    Health Passport Adherence Index (HPAI) Diet and Oral Health. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  4. Change in adherence to Health Passport recommendations-Social Health (HPAI-SH)

    Health Passport Adherence Index (HPAI) for Social Health. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  5. Change in walking endurance (200-Meter Fast Walk Test)

    Seconds to complete 200 m at fastest safe pace; lower = better. Unit: seconds.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  6. Change in gait speed (10-Meter Walk Test)

    Comfortable-pace gait speed over 10 m; meters/second; higher = better. Unit: m/s.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  7. Change in PROMIS-57 Sleep Disturbance

    PROMIS-57 Sleep Disturbance T-score (mean 50, SD 10); higher = worse. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  8. Change in PROMIS-57 Pain Interference

    PROMIS-57 (Patient-Reported Outcomes Measurement Information System.) Pain Interference T-score (mean 50, SD 10); higher = worse. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  9. Change in PROMIS-57 Fatigue

    PROMIS-57 Fatigue T-score (mean 50, SD 10); higher = worse. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  10. Change in PROMIS-57 Depression

    PROMIS-57 Depression T-score (mean 50, SD 10); higher = worse. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  11. Change in PROMIS-57 Anxiety

    PROMIS-57 (Patient-Reported Outcomes Measurement Information System) Anxiety T-score (mean 50, SD 10); higher = worse. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  12. Change in PROMIS-57 Satisfaction with Social Roles

    PROMIS-57 Satisfaction with Social Roles T-score (mean 50, SD 10); higher = better. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  13. Change in PROMIS-57 Physical Function

    PROMIS-57 (Patient-Reported Outcomes Measurement Information System) Physical Function T-score (mean 50, SD 10); higher = better function. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  14. Change in depressive symptoms (CES-D-20)

    Center for Epidemiologic Studies Depression Scale-20 items (0-3 per item based on past-week frequency: 0=rarely/none, 1=some/a little, 2=occasionally/moderate, 3=most/all); total 0-60; higher = worse depressive symptoms. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  15. Change in self-reported cognitive function (Neuro-QOL v2.0 Cognitive Function)

    Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function T-score (mean 50, SD 10); higher = better cognitive function. Unit: T-score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  16. Change in falls incidence (self-report)

    Number of falls in the prior 12 months, self-reported. Unit: number of falls. Fewer falls indicates a better outcome.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  17. Change in Central Nervous System (CNS) Vital Signs composite scores

    CNS Vital Signs is a computerized neurocognitive test battery that evaluates domains such as memory, attention, executive function, and processing speed. Scores are standardized (mean = 100, SD = 15) and age-matched, with higher scores reflecting better function.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  18. Change in systolic and diastolic blood pressure

    Resting systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized sphygmomanometer.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  19. Change in body composition (bioimpedance)

    Body composition will be measured using bioelectrical impedance analysis, reporting the percentage (%) body fat and kilograms (kg) lean tissue mass.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  20. Change in MIND Diet Score

    The MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) Diet Score measures adherence to dietary patterns associated with reduced risk of cognitive decline. Scores are based on frequency of consumption of 15 food groups. The total score ranges from 0 to 15, with higher scores indicating greater adherence to the MIND diet and better diet quality.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  21. Change in Timed Up and Go (TUG) test scores

    The Timed Up and Go test measures functional mobility. Participants are timed while standing up from a chair, walking 3 meters, turning, walking back, and sitting down. Lower times indicate better mobility.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  22. Change in 6-Minute Walk Test distance

    The 6-Minute Walk Test measures functional exercise capacity by recording the distance an individual can walk in 6 minutes on a flat surface. Greater distances, measured in meters (m), indicate better mobility and endurance.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  23. Change in Body Mass Index (BMI)

    BMI (kg/m²); numeric measure; interpretation relative to clinical ranges. In most cases, "better" scores are indicated by closer proximity to normal BMI (18.5-24.5), with lower scores indicating an underweight BMI and higher scores indicating an overweight BMI. Unit: kg/m².

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  24. Change in oral-health-related quality of life (GOHAI)

    Geriatric Oral Health Assessment Index (GOHAI); Score range is 12-60; higher = better oral-health-related quality of life. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  25. Change in perceived stress (A-SDH)

    Perceived Stress construct standardized score per A-SDH (All of Us Social Determinants of Health) scoring per U.S. Department of Health and Human Services; higher score = worse stress. Unit: standardized construct score.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

Other outcomes

  1. Change in food insecurity (A-SDH)

    Proportion of participants screening positive for food insecurity (All of Us Social Determinants of Health, from the U.S. Department of Health and Human Services); lower proportion = better. Unit: percent of participants.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  2. Change in transportation difficulty (A-SDH)

    Proportion of participants endorsing transportation barriers, per the A-SDH (All of Us Social Determinants of Health, from the U.S. Department of Health and Human Services); lower proportion = better. Unit: percent of participants.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  3. Overall adherence to Health Passport recommendations (HPAI total; exploratory)

    Sum of the four Health Passport Adherence Index (HPAI) domain scores (0-80). If one domain is N/A, average available domains and multiply by 4. Higher = better adherence. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  4. Change in Health Passport usability (HPUS; exploratory)

    Health Passport Usability Score (HPUS), 5-item Likert index (0-4 per item). Items: usefulness, clarity, ease of following, goal-setting support, sharing frequency (Likert). Total 0-20; higher = better usability. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  5. Change in arterial stiffness (arteriography)

    Arterial stiffness will be assessed by pulse wave velocity (PWV), measured in meters per second or via a comparable arteriography method. Higher values indicate greater stiffness.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  6. Change in resting heart rate

    Resting heart rate (measured in beats per minute \[bpm\]) will be measured after 5 minutes of seated rest.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

  7. Change in Health Passport Usability Score (HPUS)

    Health Passport Usability Score (HPUS), a 5 item Likert index. Each item scored 0-4 (0=strongly disagree, 1=disagree, 2=neither agree nor disagree, 3=agree, 4=strongly agree). Total 0-20; higher scores indicate better usability. Unit: points.

    Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

07

Study locations

1 site
  • Center for Optimal Aging, Marymount University
    Arlington, Virginia 22201, United States
08

References and documents

Publications

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Individual participant data

Plan to share: Yes — IPD used for the resulting publication(s) will be shared.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07180147
Lead sponsor
Marymount University
Collaborators
Potomac Health Foundations
Responsible party
Patricia C. Heyn (Vice President for Research, Marymount University) — Principal investigator
First posted
Sep 18, 2025
Start date
May 1, 2025
Primary completion
Dec 30, 2030 (estimated)
Completion
Jul 30, 2031 (estimated)
Last update
Mar 9, 2026

Study contacts

Patricia C Heyn, PhD, FGSA, FACRM
principal investigator · Office of Research, Marymount University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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