search
Back to results

Happy Older Latinos Are Active - Cognitive Decline (HOLA-CD)

Primary Purpose

Cognitive Decline

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Happy Older Latinos are Active (HOLA)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Mini Mental Status Exam score <24;
  • 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).

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HOLA Group

Arm Description

Participants in this group will receive a multicomponent intervention for 16 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in neurocognitive impairment as measured by the Trails Making Test
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.
Changes in neurocognitive impairment as measured by the WAIS-IV Digit Span
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. The scores are summarized with lower scores indicating increased cognitive impairment.
Changes in physical activity as measured by the GPAQ
The Global Physical Activity Questionnaire (GPAQ) is a summed score of recreational and transport activities in units of minutes for moderate-to-vigorous physical activity levels during a typical week will be calculated using the World Health Organization (WHO) scoring guide.
Changes in depression as measured by the PHQ-9
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
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 psychosocial functioning as measured by the MSPSS
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.
Changes in biomarkers of cognition
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
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
Adiponectin will be assessed from blood samples.

Full Information

First Posted
March 5, 2021
Last Updated
August 14, 2023
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04791709
Brief Title
Happy Older Latinos Are Active - Cognitive Decline
Acronym
HOLA-CD
Official Title
Preventing Cognitive Decline in HIV-infected Latinos Through a Culturally Tailored Health Promotion Intervention (HOLA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HOLA Group
Arm Type
Experimental
Arm Description
Participants in this group will receive a multicomponent intervention for 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Happy Older Latinos are Active (HOLA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants completing the study
Description
Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Changes in neurocognitive impairment as measured by the Trails Making Test
Description
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.
Time Frame
Baseline, 16 weeks
Title
Changes in neurocognitive impairment as measured by the WAIS-IV Digit Span
Description
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. The scores are summarized with lower scores indicating increased cognitive impairment.
Time Frame
Baseline, 16 weeks
Title
Changes in physical activity as measured by the GPAQ
Description
The Global Physical Activity Questionnaire (GPAQ) is a summed score of recreational and transport activities in units of minutes for moderate-to-vigorous physical activity levels during a typical week will be calculated using the World Health Organization (WHO) scoring guide.
Time Frame
Baseline, 16 weeks
Title
Changes in depression as measured by the PHQ-9
Description
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.
Time Frame
Baseline, 16 weeks
Title
Changes in anxiety as measured by the GAD-7
Description
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.
Time Frame
Baseline, 16 weeks
Title
Changes in psychosocial functioning as measured by the MSPSS
Description
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.
Time Frame
Baseline, 16 weeks
Title
Changes in biomarkers of cognition
Description
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.
Time Frame
Baseline, 16 weeks
Title
Changes in biomarkers of cognition levels
Description
Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.
Time Frame
Baseline, 16 weeks
Title
Changes in adiponectin
Description
Adiponectin will be assessed from blood samples.
Time Frame
Baseline, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Mini Mental Status Exam score <24; 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Jimenez, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Happy Older Latinos Are Active - Cognitive Decline

We'll reach out to this number within 24 hrs