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| ID | Type | Description | Link |
|---|---|---|---|
| PA DOH ME-02-384 | Other Grant/Funding Number | Commonwealth of Pennsylvania |
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This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify differences in cardiovascular risk, (3) evaluate mechanisms for population differences in cardiovascular risk, and (4) implement a multidisciplinary community-based intervention program to decrease cardiovascular risk in high-risk populations.
This is a prospective cohort study of 2,000 residents of the state of Pennsylvania. All participants will undergo assessments of traditional and nontraditional risk factors to identify and determine the mechanisms of population disparities in cardiovascular risk. 800 participants who are at intermediate or high risk of cardiovascular disease will be randomly assigned to either (1) usual care/"advice only"; or (2) a multidisciplinary behavioral modification program to determine the most effective approach to reduce or eliminate differences in cardiovascular risk among high risk populations. All participants will undergo long-term follow-up for cardiovascular events.
Well-established disparities exist in the prevalence and outcome of cardiovascular disease related to race and socioeconomic status (SES). Our previous work confirms these disparities and suggests that they may be related to population differences in the prevalence of nontraditional cardiovascular risk factors. We propose that these disparities can be significantly reduced or eliminated by (1) a community-based intervention program that incorporates a multidisciplinary education program led by a behavioral interventionalist, a nutritionist and an exercise physiologist, and (2) a novel approach to cardiovascular risk stratification that considers population differences in traditional and nontraditional risk factors and subclinical atherosclerosis.
To successfully implement this program, particularly in traditionally underserved communities, we have formalized a partnership between the University of Pittsburgh School of Medicine and Graduate School of Public Health, the Pittsburgh Mind-Body Center, and the Pittsburgh Theological Seminary, Urban League of Pittsburgh, and Jewish Healthcare Foundation. This partnership is positioned to study the following specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Intervention: 6 months of individualized advice regarding Nutrition, Exercise, Stress Management Counseling for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 1 |
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| 2 | Placebo Comparator | Intervenition: 6 months of Usual care for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 2. No active Nutrition, Exercise, Stress Management Counseling |
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| 3 | No Intervention | No intervention for all participants who are at low Framingham risk for CVD or have preexisting CVD prior to study entry/ No active Nutrition, Exercise, Stress Management Counseling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition, Exercise, Stress Management Counseling | Behavioral | Individualized advice |
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| Measure | Description | Time Frame |
|---|---|---|
| CVD Events | Major adverse cardiovascular events | 20 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven E Reis, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| usual care |
| Other |
usual care |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |