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

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ClinicalTrials.gov Identifier: NCT03839212
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Victoria Mitrani, University of Miami

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Cardiometabolic Risk Behavioral: HOLA Component 1 Behavioral: HOLA Component 2 Behavioral: HOLA Component 3 Behavioral: HOLA Component 4 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Happy Older Latinos are Active (HOLA)
A 16-week multi-component, health promotion intervention
Behavioral: HOLA Component 1
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.

Behavioral: HOLA Component 2
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.

Behavioral: HOLA Component 3
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.

Behavioral: HOLA Component 4
One booster walking session twice a month for three months post intervention for reinforcement.




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: Baseline ]
    Measured by 20% or less of eligible subjects refusing to participate.

  2. Retention Rate [ Time Frame: 3 months post intervention ]
    As measured by 85% or more of randomized subjects completing the post-intervention assessment.

  3. Acceptability of intervention [ Time Frame: Week 16 ]
    As measured by 80% of sessions attended by subjects


Secondary Outcome Measures :
  1. 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.

  2. Change in Psychosocial functioning as measured by Depression Severity Scale [ Time Frame: Baseline, Month 4, Month 7 ]
    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.

  3. 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.

  4. Change in Psychosocial functioning as measured by the patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, Month 4, Month 7 ]
    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.

  5. Change in Psychosocial functioning as measured by the severity of anxiety using the Generalized Anxiety Disorder scale [ Time Frame: Baseline, Month 4, Month 7 ]
    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.

  6. Change in Psychosocial functioning as measured by the severity of anxiety using the Perceived Stress Scale [ Time Frame: Baseline, Month 4, Month 7 ]
    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.

  7. 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.

  8. 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).

  9. Change in hypertension as measured by systolic and diastolic blood pressure. [ Time Frame: Baseline, Month 4, Month 7 ]
    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.

  10. Change in glucose as measured by glycated hemoglobin (Hba1c) [ Time Frame: Baseline, Month 4, Month 7 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839212


Contacts
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Contact: Daniel E. Jimenez 305-355-9043 dej18@miami.edu

Locations
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United States, Florida
Jackson Memorial Mental Health Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Victoria Mitrani, Ph.D. University of Miami

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Responsible Party: Victoria Mitrani, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03839212     History of Changes
Other Study ID Numbers: 20181032
U54MD002266 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases