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Completed

NCT Number: NCT03839212

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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiometabolic Risk Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jackson Memorial Mental Health Hospital

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HOLA Component 1

Behavioral

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.

HOLA Component 2

Behavioral

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.

HOLA Component 3

Behavioral

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.

HOLA Component 4

Behavioral

One booster walking session twice a month for three months post intervention for reinforcement.

Primary outcomes

  1. Number of Eligible Participants Refusing to Participate.

    Time frame: Baseline

    Number of eligible participants refusing to participate.

  2. 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.

  3. Acceptability of Intervention

    Time frame: Up to week 16

    As measured by the total number of sessions attended by the participants as a whole.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention

Acronym: HOLAHIV

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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