Cardiometabolic Risk, Human Immunodeficiency Virus
Conditions
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.
Interventions
BEHAVIORALHOLA 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.
BEHAVIORALHOLA 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.
BEHAVIORALHOLA Component 4
One booster walking session twice a month for three months post intervention for reinforcement.
BEHAVIORALHOLA 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.
Sponsors
University of Miami
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Participants Refusing to Participate. | Baseline | Number of eligible participants refusing to participate. |
| Retention Rate | Up to 3 months post intervention | Retention rate will be reported as the number of participants completing the post-intervention assessment. |
| Acceptability of Intervention | Up to week 16 | As measured by the total number of sessions attended by the participants as a whole. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Jimenez, Ph.D.
University of Miami
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Happy Older Latinos Are Active (HOLA) |
|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Acceptability of Intervention
As measured by the total number of sessions attended by the participants as a whole.
Time frame: Up to week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Happy Older Latinos Are Active (HOLA) | Acceptability of Intervention | 111 sessions |
Primary
Number of Eligible Participants Refusing to Participate.
Number of eligible participants refusing to participate.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Happy Older Latinos Are Active (HOLA) | Number of Eligible Participants Refusing to Participate. | 0 Participants |
Primary
Retention Rate
Retention rate will be reported as the number of participants completing the post-intervention assessment.
Time frame: Up to 3 months post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Happy Older Latinos Are Active (HOLA) | Retention Rate | 14 Participants |
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.
Time frame: Baseline, 7 months post intervention
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.
Time frame: Baseline, Month 4, Month 7
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.
Time frame: Baseline, Month 4, Month 7
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.
Time frame: Baseline, Month 4, Month 7
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).
Time frame: Baseline, Month 4, Month 7
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.
Time frame: Baseline, Month 4, Month 7
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.
Time frame: Baseline, Month 4, Month 7
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.
Time frame: Baseline, Month 4, Month 7
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.
Time frame: Baseline, Month 4, Month 7
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.
Time frame: Baseline, Month 4, Month 7