Trial Outcomes & Findings for The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men (NCT NCT03839212)
NCT ID: NCT03839212
Last Updated: 2021-08-16
Results Overview
Number of eligible participants refusing to participate.
COMPLETED
NA
18 participants
Baseline
2021-08-16
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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18
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|
Overall Study
COMPLETED
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14
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
COVID-19 related suspension of research activities.
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4
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Baseline Characteristics
The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men
Baseline characteristics by cohort
| Measure |
Happy Older Latinos Are Active (HOLA)
n=18 Participants
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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Age, Continuous
|
60.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
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|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineNumber of eligible participants refusing to participate.
Outcome measures
| Measure |
Happy Older Latinos Are Active (HOLA)
n=18 Participants
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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|---|---|
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Number of Eligible Participants Refusing to Participate.
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0 Participants
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PRIMARY outcome
Timeframe: Up to 3 months post interventionRetention rate will be reported as the number of participants completing the post-intervention assessment.
Outcome measures
| Measure |
Happy Older Latinos Are Active (HOLA)
n=18 Participants
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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|---|---|
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Retention Rate
|
14 Participants
|
PRIMARY outcome
Timeframe: Up to week 16As measured by the total number of sessions attended by the participants as a whole.
Outcome measures
| Measure |
Happy Older Latinos Are Active (HOLA)
n=18 Participants
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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|---|---|
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Acceptability of Intervention
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111 sessions
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SECONDARY outcome
Timeframe: Baseline, 7 months post interventionAs 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7As 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7severity 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7A 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7Normal 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 7The 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.
Outcome measures
Outcome data not reported
Adverse Events
Happy Older Latinos Are Active (HOLA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Daniel E. Jimenez, Ph.D., Associate Professor
University of Miami
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place