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The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men (HOLAHIV)

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University of Miami

Status

Completed

Conditions

Human Immunodeficiency Virus
Cardiometabolic Risk

Treatments

Behavioral: HOLA Component 1
Behavioral: HOLA Component 4
Behavioral: HOLA Component 2
Behavioral: HOLA Component 3

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03839212
U54MD002266 (U.S. NIH Grant/Contract)
20181032

Details and patient eligibility

About

The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults living with HIV. The investigators expect that the participant will be in this study for seven months. Participants will be interviewed and asked to take part in walking groups.

Enrollment

18 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • are Latino (self-identified);
  • are age 50+ years;
  • are male;
  • are HIV infected but are virologically suppressed (viral load <200 copies/mL);
  • volunteer informed consent;
  • have medical clearance by a physician;
  • expect to stay in Miami for the next 6 months; and
  • have documented risk of cardiometabolic disease.

Exclusion criteria

  • diabetes diagnosis;
  • at baseline meet criteria for current major depressive disorder or generalized anxiety disorder;
  • meet criteria for current alcohol or other substance abuse disorders;
  • have a lifetime history of bipolar disorder or other psychotic disorder;
  • have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score <24;
  • have contraindications to physical activity outlined in the American College of Sports Medicine standards;
  • have high suicide risk i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
  • are unable to complete 10 m walk test;
  • currently residing in a nursing or group home;
  • have a terminal physical illness expected to result in the death within one year;
  • have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Happy Older Latinos are Active (HOLA)
Experimental group
Description:
A 16-week multi-component, health promotion intervention
Treatment:
Behavioral: HOLA Component 4
Behavioral: HOLA Component 2
Behavioral: HOLA Component 1
Behavioral: HOLA Component 3

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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