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

Primary Purpose

Human Immunodeficiency Virus, Cardiometabolic Risk

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HOLA Component 1
HOLA Component 2
HOLA Component 3
HOLA Component 4
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Human Immunodeficiency Virus

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Jackson Memorial Mental Health Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Happy Older Latinos are Active (HOLA)

Arm Description

A 16-week multi-component, health promotion intervention

Outcomes

Primary Outcome Measures

Number of Eligible Participants Refusing to Participate.
Number of eligible participants refusing to participate.
Retention Rate
Retention rate will be reported as the number of participants completing the post-intervention assessment.
Acceptability of Intervention
As measured by the total number of sessions attended by the participants as a whole.

Secondary Outcome Measures

Change in Cardiometabolic Risk as Measured by Waist Circumference
As measured by the number of inches around the participant's waist. A waist circumference of 102 centimetres (40 inches) or more in men is associated with health problems such as type 2 diabetes, heart disease and high blood pressure.
Change in Psychosocial Functioning as Measured by Depression Severity Scale
As measured by a 20-item Center for Epidemiologic Studies Depression (CES-D) scale. The possible range of scores are 0 to 60 with the higher scores indicating the presence of more symptomatology.
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)
The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life.
Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)
severity of depression will be measured by the 9-item PHQ-9. Scores range from 0 to 27. With scores of 1-4 indicating minimal depression and scores of 20-27 indicating severe depression.
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale
The 7-item Generalized Anxiety Disorder (GAD-7) scale will be used to measure the severity of anxiety. The scores range from 0 to 21 with scores of 0 to 5 indicating mild anxiety and scores of 15-21 indicating severe anxiety.
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale
The 14 item Healthy Families Program Perceived Stress Scale will be used to measure the severity of anxiety. PSS scores can range from 0 to 40 with higher scores indicated higher perception of stress.
Change in Psychosocial Functioning as Measured by the Social Support Received
The 12 item Multidimensional Scale of Perceived Social support. After calculating the mean score across the categories a mean scale support score from 1 to 2.9 would indicate low support, whereas a mean score of 5.1 to 7 would indicate high support.
Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides
A total cholesterol value of less than 200 mg/dL (5.18 mmol/L) is desirable and 240 mg/dL (6.22 mmol/L) or higher is high. Average HDL-C level is 40-50 mg/dL (1.0-1.3 mmol/L) for men. Low HDL-C level, increased risk, is less than 40 mg/dL (1.0 mmol/L). Optimal LDL-C levels are less than 100 mg/d while high levels are 160-189 mg/dL (4.15-4.90 mmol/L). Desirable triglyceride levels are less than 150 mg/dL (1.70 mmol/L) while high levels are considered 200-499 mg/dL (2.3-5.6 mmol/L).
Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.
Normal systolic and diastolic pressure is less than 120 mmHg and 80mmHg, respectively. High systolic and diastolic pressure is 140 mmHg or higher and 90 mmHg or higher, respectively.
Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)
The normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean a higher chance of getting diabetes. Levels of 6.5% or higher mean diabetes.

Full Information

First Posted
February 8, 2019
Last Updated
July 21, 2021
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03839212
Brief Title
The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men
Acronym
HOLAHIV
Official Title
Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 27, 2020 (Actual)
Study Completion Date
October 27, 2020 (Actual)

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)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Cardiometabolic Risk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Happy Older Latinos are Active (HOLA)
Arm Type
Experimental
Arm Description
A 16-week multi-component, health promotion intervention
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 1
Intervention Description
At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 2
Intervention Description
A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 3
Intervention Description
A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.
Intervention Type
Behavioral
Intervention Name(s)
HOLA Component 4
Intervention Description
One booster walking session twice a month for three months post intervention for reinforcement.
Primary Outcome Measure Information:
Title
Number of Eligible Participants Refusing to Participate.
Description
Number of eligible participants refusing to participate.
Time Frame
Baseline
Title
Retention Rate
Description
Retention rate will be reported as the number of participants completing the post-intervention assessment.
Time Frame
Up to 3 months post intervention
Title
Acceptability of Intervention
Description
As measured by the total number of sessions attended by the participants as a whole.
Time Frame
Up to week 16
Secondary Outcome Measure Information:
Title
Change in Cardiometabolic Risk as Measured by Waist Circumference
Description
As measured by the number of inches around the participant's waist. A waist circumference of 102 centimetres (40 inches) or more in men is associated with health problems such as type 2 diabetes, heart disease and high blood pressure.
Time Frame
Baseline, 7 months post intervention
Title
Change in Psychosocial Functioning as Measured by Depression Severity Scale
Description
As measured by a 20-item Center for Epidemiologic Studies Depression (CES-D) scale. The possible range of scores are 0 to 60 with the higher scores indicating the presence of more symptomatology.
Time Frame
Baseline, Month 4, Month 7
Title
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)
Description
The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life.
Time Frame
Baseline, Month 4, Month 7
Title
Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)
Description
severity of depression will be measured by the 9-item PHQ-9. Scores range from 0 to 27. With scores of 1-4 indicating minimal depression and scores of 20-27 indicating severe depression.
Time Frame
Baseline, Month 4, Month 7
Title
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale
Description
The 7-item Generalized Anxiety Disorder (GAD-7) scale will be used to measure the severity of anxiety. The scores range from 0 to 21 with scores of 0 to 5 indicating mild anxiety and scores of 15-21 indicating severe anxiety.
Time Frame
Baseline, Month 4, Month 7
Title
Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale
Description
The 14 item Healthy Families Program Perceived Stress Scale will be used to measure the severity of anxiety. PSS scores can range from 0 to 40 with higher scores indicated higher perception of stress.
Time Frame
Baseline, Month 4, Month 7
Title
Change in Psychosocial Functioning as Measured by the Social Support Received
Description
The 12 item Multidimensional Scale of Perceived Social support. After calculating the mean score across the categories a mean scale support score from 1 to 2.9 would indicate low support, whereas a mean score of 5.1 to 7 would indicate high support.
Time Frame
Baseline, Month 4, Month 7
Title
Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides
Description
A total cholesterol value of less than 200 mg/dL (5.18 mmol/L) is desirable and 240 mg/dL (6.22 mmol/L) or higher is high. Average HDL-C level is 40-50 mg/dL (1.0-1.3 mmol/L) for men. Low HDL-C level, increased risk, is less than 40 mg/dL (1.0 mmol/L). Optimal LDL-C levels are less than 100 mg/d while high levels are 160-189 mg/dL (4.15-4.90 mmol/L). Desirable triglyceride levels are less than 150 mg/dL (1.70 mmol/L) while high levels are considered 200-499 mg/dL (2.3-5.6 mmol/L).
Time Frame
Baseline, Month 4, Month 7
Title
Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.
Description
Normal systolic and diastolic pressure is less than 120 mmHg and 80mmHg, respectively. High systolic and diastolic pressure is 140 mmHg or higher and 90 mmHg or higher, respectively.
Time Frame
Baseline, Month 4, Month 7
Title
Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)
Description
The normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean a higher chance of getting diabetes. Levels of 6.5% or higher mean diabetes.
Time Frame
Baseline, Month 4, Month 7

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Jackson Memorial Mental Health Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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