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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD002266 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Happy Older Latinos are Active (HOLA) | Experimental | A 16-week multi-component, health promotion intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eligible Participants Refusing to Participate. | Number of eligible participants refusing to participate. | Baseline |
| Retention Rate | Retention rate will be reported as the number of participants completing the post-intervention assessment. | Up to 3 months post intervention |
| Acceptability of Intervention | As measured by the total number of sessions attended by the participants as a whole. | Up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 7 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Jimenez, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Mental Health Hospital | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36855194 | Derived | Jimenez DE, Weinstein ER, Batsis J. You gotta walk the walk to talk the talk: protocol for a feasibility study of the Happy Older Latino Adults (HOLA) health promotion intervention for older HIV-positive Latino men. Pilot Feasibility Stud. 2023 Feb 28;9(1):32. doi: 10.1186/s40814-023-01262-w. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Happy Older Latinos Are Active (HOLA) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Happy Older Latinos Are Active (HOLA) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Eligible Participants Refusing to Participate. | Number of eligible participants refusing to participate. | Posted | Count of Participants | Participants | Baseline |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Happy Older Latinos Are Active (HOLA) | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel E. Jimenez, Ph.D., Associate Professor | University of Miami | 3052432776 | dej18@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2021 | Jul 21, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2018 | Mar 15, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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. |
|
| 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. |
| Baseline, Month 4, Month 7 |
| 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. | Baseline, Month 4, Month 7 |
| 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. | Baseline, Month 4, Month 7 |
| 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. | Baseline, Month 4, Month 7 |
| 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. | Baseline, Month 4, Month 7 |
| 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. | Baseline, Month 4, Month 7 |
| 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). | Baseline, Month 4, Month 7 |
| 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. | Baseline, Month 4, Month 7 |
| 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. | Baseline, Month 4, Month 7 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Retention Rate | Retention rate will be reported as the number of participants completing the post-intervention assessment. | Posted | Count of Participants | Participants | Up to 3 months post intervention |
|
|
|
| Primary | Acceptability of Intervention | As measured by the total number of sessions attended by the participants as a whole. | Posted | Number | sessions | Up to week 16 |
|
|
|
| Secondary | 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. | Not Posted | Baseline, 7 months post intervention | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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). | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| Secondary | 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. | Not Posted | Baseline, Month 4, Month 7 | Participants |
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |