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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. This observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.
The study features piloting of a cluster-randomized trial to determine whether a positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition. The pilot trial additionally evaluates the efficacy of the PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein. Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Psychological Intervention | Experimental | Our culturally-tailored Positive Psychology (PP) Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience. |
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| Wait list control | No Intervention | Receipt after the active treatment group has completed the positive psychological intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychological Intervention | Behavioral | Our culturally-tailored Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Ambulatory Blood Pressure at 8- and 12-weeks | The device, Vitavue, consists of a wireless microcontroller that connects to a desktop computer running proprietary software when operated in real time connected mode. Alternatively, it can be operated in standalone unconnected mode by logging acquired data to an internal memory storage device. The device contains a number of sensors including ECG single channel amplifier, Multispectral Photodiode to record photo pulse plethysmograms, temperature sensor to measure skin temperature, and an accelerometer to record the level of activity. | Baseline, 8-, and 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiological Studies Depression Scale (CESD): Change from Baseline Depressive Symptoms at 8- and 12-weeks | Center for Epidemiological Studies Depression-Scale | Baseline, 8-, and 12-weeks |
| Life Orientation Test-Revised (LOT-R): Change from Baseline Dispositional Optimism at 8- and 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity: Change in Hypertension-related Health Behavior(s) | Physical Activity using Fitbit One | Baseline, 8-, and 12-weeks |
| Diet: Change in Hypertension-related Health Behavior(s) | Diet using Scored Sodium Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosalba Hernandez, PhD | Contact | 217-300-1049 | rherna17@illinois.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Pius V Parish | Recruiting | Chicago | Illinois | 60608 | United States |
We will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to use data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate technology; and (3) a commitment to destroy or return data after analyses are completed. If additional outputs result from this research that would be appropriate to share with a wider audience, we will work with the Research Data Service at the University Library to determine appropriate venues for archiving and sharing.
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Cluster-randomized control trial
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Outcome assessors will be blind to intervention assignment and will only collect clinical data at baseline, 8-, and 12-weeks.
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Life Orientation Test-Revised |
| Baseline, 8-, and 12-weeks |
| General Well-being Schedule: Change in Baseline Emotional Vitality at 8- and 12-weeks | General Well-being Schedule | Baseline, 8-, and 12-weeks |
| Life Engagement Test (LET): Change in Baseline Life engagement and Meaning at 8- and 12-weeks | Life Engagement Test | Baseline, 8-, and 12-weeks |
| Baseline, 8-, and 12-weeks |
| Change in Heart Rate Variability | Beat-to-beat interval | Baseline, 8-, and 12-weeks |
| Change in High-sensitivity C-Reactive Protein | mg/L | Baseline, 8-, and 12-weeks |