Happy Older Latinos Are Active - Cognitive Decline

Preventing Cognitive Decline in HIV-infected Latinos Through a Culturally Tailored Health Promotion Intervention (HOLA)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04791709

Acronym

HOLA-CD

Enrollment

Registered

2021-03-10

Start date

2022-02-01

Completion date

2025-03-12

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline

Brief summary

The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV.

Detailed description

The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV. It assesses the feasibility of running a health promotion program, led by a community health worker (CHW) intended to help prevent cognitive decline (loss of memory and/or functioning) through a culturally tailored health promotion intervention . Eligible participants will be Latino/Hispanic individuals 50 years of age or older, living with HIV, who may be at risk of developing chronic diseases such as dementia and Alzherimer's.

Interventions

BEHAVIORALHappy Older Latinos are Active (HOLA)

HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* are Latino (self-identified); * are age 50+; * are HIV infected but are virologically suppressed (viral load \<200 copies/mL); * volunteer informed consent

Exclusion criteria

* have diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's disease, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Telephone Interview for Cognitive Status (TICS) score less than or equal to 30; * have other conditions that could impact cognitive functioning or testing (e.g., legally blind or deaf), currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes. * have contraindications to physical activity outlined in the American College of Sports Medicine standards or severe medical illness that precludes them from safely participating in a health promotion intervention. * are unable to complete 10-meter walk test. * have plans to move outside of the Miami metropolitan area within the next 6 months or are not living in stable housing (e.g. group home).

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Completing the Study	16 weeks	Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.

Secondary

Measure	Time frame	Description
Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span	Baseline, 16 weeks	The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) asks participants to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each correct response earns 1 point, and the total raw score is converted to a scaled score ranging from 1 to 19. Higher scores indicate better cognitive performance; lower scores reflect increased neurocognitive impairment.
Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ)	Baseline, 16 weeks	The Global Physical Activity Questionnaire (GPAQ) scoring is based on the amount of time a person spends being physically active in a typical week. It looks at three areas: activity at work or during daily tasks (including heavy lifting, digging, carrying loads, or light activities like cleaning); traveling from place to place (like walking or cycling); and recreational activities (such as exercise, sports, or active hobbies). Each activity is converted into a standard unit called MET-minutes (Metabolic Equivalent of Task). This allows different types of activity to be compared on the same scale. The total MET-minutes per week are calculated by multiplying: Minutes per day × Days per week × MET value with higher scores indicating greater levels of activity.
Changes in Depression as Measured by the PHQ-9	Baseline, 16 weeks	The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that measures depression severity. The total score ranges from 0-27 with higher scores indicating more severe depression.
Changes in Anxiety as Measured by the GAD-7	Baseline, 16 weeks	The Generalized Anxiety Disorder (GAD-7) is a 7 item questionnaire that measures anxiety severity. The total score ranges from 0-21 with higher scores indicating more severe anxiety.
Changes in Neurocognitive Impairment as Measured by the Trails Making Test	Baseline, 16 weeks	Trail Making Test (TMT). Time to accurately complete Part A and Part B. The TMT measures neurocognitive functioning and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment measured in seconds.
Changes in Biomarkers of Cognition	Baseline, 16 weeks	Biomarkers of cognition including interleukin-15, brain derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEG-F) reported in pg/ml will be assessed from blood samples.
Changes in Biomarkers of Cognition Levels	Baseline, 16 weeks	Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.
Changes in Adiponectin	Baseline, 16 weeks	Adiponectin will be assessed from blood samples measured by ng/ml
Changes in Psychosocial Functioning as Measured by the MSPSS	Baseline, 16 weeks	The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item questionnaire that measures perceived social support. The total score ranges from 1-84 with higher scores indicating more perceived social support.

Countries

United States

Participant flow

Participants by arm

Arm	Count
HOLA Group Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.	30
Total	30

Arm

Count

HOLA Group

Participants in this group will receive a multicomponent intervention for 16 weeks. Happy Older Latinos are Active (HOLA): HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	HOLA Group
Age, Continuous	61.7 years STANDARD_DEVIATION 6
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	25 Participants
Sex: Female, Male Female	12 Participants
Sex: Female, Male Male	18 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	0 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

Percentage of Participants Completing the Study

Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.

Time frame: 16 weeks

Arm	Measure	Value (NUMBER)
HOLA Group	Percentage of Participants Completing the Study	90 Percentage of participants

Secondary