Arlington Longitudinal Optimal Healthy Aging Study (ALOHA)

Recruiting

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

• Registration Number: NCT07180147
• Lead Sponsor: Marymount University

Brief 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.

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.

Study Timeline

• Study Start: 2025-05-01
• Study First Submitted: 2025-08-15
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2030-12-30
• Study Completion: 2031-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in adherence to Health Passport recommendations-Physical/Cardiovascular Health (HPAI-PC)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in adherence to Health Passport recommendations-Cognitive, Sleep, and Mental Health (HPAI-CSM)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.

Secondary Outcome Measures

Name	Time	Method
Change in Montreal Cognitive Assessment (MoCA) score	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in static balance (Four-Stage Balance Test)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Total seconds successfully held across 4 stances (0-40 s); higher = better. Unit: seconds.
Change in adherence to Health Passport recommendations-Diet and Oral Health (HPAI-DO)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in adherence to Health Passport recommendations-Social Health (HPAI-SH)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in walking endurance (200-Meter Fast Walk Test)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Seconds to complete 200 m at fastest safe pace; lower = better. Unit: seconds.
Change in PROMIS-57 Pain Interference	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	PROMIS-57 (Patient-Reported Outcomes Measurement Information System.) Pain Interference T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Change in PROMIS-57 Anxiety	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	PROMIS-57 (Patient-Reported Outcomes Measurement Information System) Anxiety T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Change in PROMIS-57 Satisfaction with Social Roles	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	PROMIS-57 Satisfaction with Social Roles T-score (mean 50, SD 10); higher = better. Unit: T-score.
Change in PROMIS-57 Physical Function	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	PROMIS-57 (Patient-Reported Outcomes Measurement Information System) Physical Function T-score (mean 50, SD 10); higher = better function. Unit: T-score.
Change in depressive symptoms (CES-D-20)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in self-reported cognitive function (Neuro-QOL v2.0 Cognitive Function)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function T-score (mean 50, SD 10); higher = better cognitive function. Unit: T-score.
Change in falls incidence (self-report)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Number of falls in the prior 12 months, self-reported. Unit: number of falls. Fewer falls indicates a better outcome.
Change in gait speed (10-Meter Walk Test)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Comfortable-pace gait speed over 10 m; meters/second; higher = better. Unit: m/s.
Change in PROMIS-57 Sleep Disturbance	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	PROMIS-57 Sleep Disturbance T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Change in PROMIS-57 Fatigue	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	PROMIS-57 Fatigue T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Change in PROMIS-57 Depression	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	PROMIS-57 Depression T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Change in Central Nervous System (CNS) Vital Signs composite scores	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in systolic and diastolic blood pressure	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Resting systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized sphygmomanometer.
Change in body composition (bioimpedance)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Body composition will be measured using bioelectrical impedance analysis, reporting the percentage (%) body fat and kilograms (kg) lean tissue mass.
Change in MIND Diet Score	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in Timed Up and Go (TUG) test scores	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in 6-Minute Walk Test distance	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in Body Mass Index (BMI)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.
Change in oral-health-related quality of life (GOHAI)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	Geriatric Oral Health Assessment Index (GOHAI); Score range is 12-60; higher = better oral-health-related quality of life. Unit: points.
Change in perceived stress (A-SDH)	Baseline and 12 months (with annual re-testing up to 5 years, per protocol).	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.

Trial Locations

Locations (1)

Center for Optimal Aging, Marymount University; 🇺🇸 Arlington, Virginia, United States