- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839212
The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men (HOLAHIV)
July 21, 2021 updated by: Daniel Enrique Jimenez, University of Miami
Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Jackson Memorial Mental Health Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Happy Older Latinos are Active (HOLA)
A 16-week multi-component, health promotion intervention
|
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.
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.
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.
One booster walking session twice a month for three months post intervention for reinforcement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Eligible Participants Refusing to Participate.
Time Frame: Baseline
|
Number of eligible participants refusing to participate.
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Baseline
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Retention Rate
Time Frame: Up to 3 months post intervention
|
Retention rate will be reported as the number of participants completing the post-intervention assessment.
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Up to 3 months post intervention
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Acceptability of Intervention
Time Frame: Up to week 16
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As measured by the total number of sessions attended by the participants as a whole.
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Up to week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cardiometabolic Risk as Measured by Waist Circumference
Time Frame: Baseline, 7 months post intervention
|
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.
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Baseline, 7 months post intervention
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Change in Psychosocial Functioning as Measured by Depression Severity Scale
Time Frame: Baseline, Month 4, Month 7
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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.
|
Baseline, Month 4, Month 7
|
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)
Time Frame: Baseline, Month 4, Month 7
|
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.
|
Baseline, Month 4, Month 7
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Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, Month 4, Month 7
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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.
|
Baseline, Month 4, Month 7
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Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale
Time Frame: Baseline, Month 4, Month 7
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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.
|
Baseline, Month 4, Month 7
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Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale
Time Frame: Baseline, Month 4, Month 7
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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.
|
Baseline, Month 4, Month 7
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Change in Psychosocial Functioning as Measured by the Social Support Received
Time Frame: Baseline, Month 4, Month 7
|
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.
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Baseline, Month 4, Month 7
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Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides
Time Frame: Baseline, Month 4, Month 7
|
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).
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Baseline, Month 4, Month 7
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Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.
Time Frame: Baseline, Month 4, Month 7
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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.
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Baseline, Month 4, Month 7
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Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)
Time Frame: Baseline, Month 4, Month 7
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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.
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Baseline, Month 4, Month 7
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Jimenez, Ph.D., University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
July 27, 2020
Study Completion (Actual)
October 27, 2020
Study Registration Dates
First Submitted
February 8, 2019
First Submitted That Met QC Criteria
February 12, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
August 16, 2021
Last Update Submitted That Met QC Criteria
July 21, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 20181032
- U54MD002266 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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