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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT03839212
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 1.4

Study Details

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.

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Jul 27, 2020
• Actual Study Completion Date: Oct 27, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Eligible Participants Refusing to Participate. [Baseline]

   Number of eligible participants refusing to participate.

2. Retention Rate [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 [Up to week 16]

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

Secondary Outcome Measures

1. Change in Cardiometabolic Risk as Measured by Waist Circumference [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 [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) [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) [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 [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 [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 [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 [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. [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Daniel Jimenez, Ph.D., University of Miami

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 16, 2021
• Informed Consent Form - Nov 28, 2018

More Information

Publications

None provided.

• Responsible Party: Daniel Enrique Jimenez, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03839212
• Other Study ID Numbers: 20181032; U54MD002266
• First Posted: Feb 15, 2019
• Last Update Posted: Aug 16, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

Participant Flow

Arm/Group Title	Happy Older Latinos Are Active (HOLA)
Arm/Group Description	A 16-week multi-component, health promotion intervention 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. 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. 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. HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.
Period Title: Overall Study
STARTED	18
COMPLETED	14
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Happy Older Latinos Are Active (HOLA)
Arm/Group Description	A 16-week multi-component, health promotion intervention 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. 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. 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. HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.
Overall Participants	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.5 (6.2)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	18 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	18 100%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	18 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Eligible Participants Refusing to Participate.
Description	Number of eligible participants refusing to participate.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Happy Older Latinos Are Active (HOLA)
Arm/Group Description	A 16-week multi-component, health promotion intervention 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. 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. 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. HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.
Measure Participants	18
Count of Participants [Participants]	0 0%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Happy Older Latinos Are Active (HOLA)
Arm/Group Description	A 16-week multi-component, health promotion intervention 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. 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. 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. HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.
Measure Participants	18
Count of Participants [Participants]	14 77.8%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Happy Older Latinos Are Active (HOLA)
Arm/Group Description	A 16-week multi-component, health promotion intervention 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. 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. 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. HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.
Measure Participants	18
Number [sessions]	111

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	7 months
Arm/Group Title	Happy Older Latinos Are Active (HOLA)
Arm/Group Description	A 16-week multi-component, health promotion intervention 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. 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. 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. HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.
All Cause Mortality
	Happy Older Latinos Are Active (HOLA)
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Serious Adverse Events
	Happy Older Latinos Are Active (HOLA)
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Happy Older Latinos Are Active (HOLA)
	Affected / at Risk (%)	# Events
Total	0/18 (0%)

Limitations/Caveats

All clinical research activities at the University of Miami were suspended due to the Coronavirus Disease of 2019 (COVID-19) pandemic. As a result, data collection and participant retention were impacted.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.