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| ID | Type | Description | Link |
|---|---|---|---|
| MDA W81XWH-05-2-0075 | Other Grant/Funding Number | Department of Defense |
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The purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.
This project will use an integrated approach that examines DNA variation and the functional products of genes at both the messenger RNA (mRNA) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (CHD). DNA variants and/or changes in gene and protein expression associated with CHD reversal may provide important clues to understanding molecular mechanisms of subclinical CHD development and progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Dr. Dean Ornish Program for Reversing Heart Disease |
|
| Control | No Intervention | Non-intervention controls retrospectively matched to intervention participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dr. Dean Ornish Program for Reversing Heart Disease | Behavioral | Prospective, nonrandomized clinical intervention to stabilize or reverse progression of heart disease through changes in lifestyle. Lifestyle intervention consisted of four components: 1) a very low fat vegetarian diet (<10% of calories from fat); 2) 180 minutes/week of moderate aerobic exercise; 3) one hour of stress management each day; and 4) weekly group support sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index | Change in BMI from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Change in BP from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks |
| Change in lipids | Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrell L Ellsworth, PhD | Windber Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Windber Medical Center | Windber | Pennsylvania | 15963 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15539963 | Result | Ellsworth DL, O'Dowd SC, Salami B, Hochberg A, Vernalis MN, Marshall D, Morris JA, Somiari RI. Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Prev Cardiol. 2004 Fall;7(4):168-75. doi: 10.1111/j.1520-037x.2004.3332.x. | |
| 18197071 | Result |
| Label | URL |
|---|---|
| Windber Research Institute home page | View source |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Baseline, 12 weeks, 52 weeks |
| Change in exercise capacity | Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks |
| Vizza J, Neatrour DM, Felton PM, Ellsworth DL. Improvement in psychosocial functioning during an intensive cardiovascular lifestyle modification program. J Cardiopulm Rehabil Prev. 2007 Nov-Dec;27(6):376-83; quiz 384-5. doi: 10.1097/01.HCR.0000300264.07764.84. |
| 19563671 | Result | Decewicz DJ, Neatrour DM, Burke A, Haberkorn MJ, Patney HL, Vernalis MN, Ellsworth DL. Effects of cardiovascular lifestyle change on lipoprotein subclass profiles defined by nuclear magnetic resonance spectroscopy. Lipids Health Dis. 2009 Jun 29;8:26. doi: 10.1186/1476-511X-8-26. |
| 22633795 | Result | Voeghtly LM, Neatrour DM, Decewicz DJ, Burke A, Haberkorn MJ, Lechak F, Patney HL, Vernalis MN, Ellsworth DL. Cardiometabolic risk reduction in an intensive cardiovascular health program. Nutr Metab Cardiovasc Dis. 2013 Jul;23(7):662-9. doi: 10.1016/j.numecd.2012.01.012. Epub 2012 May 26. |
| 24563419 | Derived | Ellsworth DL, Croft DT Jr, Weyandt J, Sturtz LA, Blackburn HL, Burke A, Haberkorn MJ, McDyer FA, Jellema GL, van Laar R, Mamula KA, Chen Y, Vernalis MN. Intensive cardiovascular risk reduction induces sustainable changes in expression of genes and pathways important to vascular function. Circ Cardiovasc Genet. 2014 Apr;7(2):151-60. doi: 10.1161/CIRCGENETICS.113.000121. Epub 2014 Feb 21. |