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| ID | Type | Description | Link |
|---|---|---|---|
| W81XHW-06-1-0565 |
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The primary aim of the proposed research is to examine the relationship of lifestyle changes to new dietary, biomedical, and cellular parameters among new enrollees entering the "Dr. Dean Ornish Program for Reversing Heart Disease program" at 5 selected sites. Specifically, the investigators will add assessments of emerging cardiac risk factors (e.g., high sensitivity C-reactive protein [hsCRP], fibrinogen, lipoprotein(a) [Lp(a)], small, dense LDL, apolipoprotein B [apoB], apolipoprotein A-I [apo A1], the apoB/apoA1 ratio, homocysteine [Hcy], B-type natriuretic peptide [BNP], oxidized LDL, fasting insulin and waist-to-hip ratio [WHR]), protective and pathogenic dietary markers (e.g., folate, carotenoids, trans fatty acids), and measures of social support and cognitive functioning to the already existing assessment variables in the Multisite Cardiac Lifestyle Intervention Program (MCLIP).
Hypothesis 1: Participation in the lifestyle program will not only be associated with favorable changes in standard coronary risk factors and quality of life, but also with improvements in emerging cardiac risk factors [hsCRP, Hcy, BNP, fibrinogen, Lp(a), small, dense LDL, apoB, apoA1, oxidized LDL, fasting insulin, and abdominal obesity] and psychosocial well-being (i.e., social support, and cognitive functioning).
Hypothesis 2: High intake of emerging protective dietary factors and low intake of emerging pathogenic dietary factors will be associated with improvements in both standard and emerging cardiac risk factors (e.g. Hcy, oxidized LDL).
Hypothesis 3: Degree of adherence to the lifestyle change program will be associated with differential improvement in standard coronary risk factors, emerging risk factors, cellular aging, and psychosocial variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Other | Comprehensive lifestyle intervention for reversal of heart disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dr. Dean Ornish Program for Reversing Heart Disease | Behavioral | Exercise: At least 3 hours of aerobic exercise per week, 30 minutes per session. Additionally, patients are asked to perform a minimum of 2 strength training sessions per week. Stress Management: Integrates stretching, relaxation, breathing techniques, meditation and guided imagery. Patients are asked to practice these techniques at least 1 hour per day. Diet: Approximately 10% daily calories from fat, 15% protein and 75% complex carbohydrates (low-fat, whole foods, primarily plant-based). Group Support: Weekly group support sessions provide social support to help patients adhere to and sustain the lifestyle-change program. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of Cardiovascular Disease | Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake | Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment |
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Inclusion Criteria:
Eligible patients included those who had a diagnosis of coronary heart disease (CHD) from their physician or health plan, a diagnosis of diabetes, or at least 3 additional cardiac risk factors.
A diagnosis of CHD included:
Type I or Type II diabetics were eligible for the program.
For a participant to be included as a high-risk factor participant, the participant must have either a family history of premature CHD (1st-degree relative (male<55; female <65) with MI or sudden cardiac death) or be a male aged > 45 or a female aged > 55.
In addition, there must be at least two additional cardiovascular risk factors, including:
Exclusion Criteria:
Exclusion criteria included:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Kersh, MD, FACC | St. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc | Principal Investigator |
| Dean Ornish, MD | Preventive Medicine Research Institute | Principal Investigator |
| Gerdi Weidner, PhD | Preventive Medicine Research Institute | Principal Investigator |
| Nita Chainani-Wu, DMD, MS, PhD | Preventive Medicine Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preventive Medicine Research Institute | Sausalito | California | 94965 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18923113 | Background | Govil SR, Weidner G, Merritt-Worden T, Ornish D. Socioeconomic status and improvements in lifestyle, coronary risk factors, and quality of life: the Multisite Cardiac Lifestyle Intervention Program. Am J Public Health. 2009 Jul;99(7):1263-70. doi: 10.2105/AJPH.2007.132852. Epub 2008 Oct 15. | |
| 18823185 | Background |
| Label | URL |
|---|---|
| Preventive Medicine Research Institute website homepage | View source |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Pischke CR, Scherwitz L, Weidner G, Ornish D. Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. Health Psychol. 2008 Sep;27(5):584-92. doi: 10.1037/0278-6133.27.5.584. |
| 18825581 | Background | Schulz U, Pischke CR, Weidner G, Daubenmier J, Elliot-Eller M, Scherwitz L, Bullinger M, Ornish D. Social support group attendance is related to blood pressure, health behaviours, and quality of life in the Multicenter Lifestyle Demonstration Project. Psychol Health Med. 2008 Aug;13(4):423-37. doi: 10.1080/13548500701660442. |
| 18359307 | Background | Frattaroli J, Weidner G, Merritt-Worden TA, Frenda S, Ornish D. Angina pectoris and atherosclerotic risk factors in the multisite cardiac lifestyle intervention program. Am J Cardiol. 2008 Apr 1;101(7):911-8. doi: 10.1016/j.amjcard.2007.11.039. Epub 2008 Jan 28. |
| 17572148 | Background | Pischke CR, Weidner G, Elliott-Eller M, Ornish D. Lifestyle changes and clinical profile in coronary heart disease patients with an ejection fraction of <or=40% or >40% in the Multicenter Lifestyle Demonstration Project. Eur J Heart Fail. 2007 Sep;9(9):928-34. doi: 10.1016/j.ejheart.2007.05.009. Epub 2007 Jun 14. |
| 17291171 | Background | Daubenmier JJ, Weidner G, Sumner MD, Mendell N, Merritt-Worden T, Studley J, Ornish D. The contribution of changes in diet, exercise, and stress management to changes in coronary risk in women and men in the multisite cardiac lifestyle intervention program. Ann Behav Med. 2007 Feb;33(1):57-68. doi: 10.1207/s15324796abm3301_7. |
| 16094059 | Background | Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73. |
| 9863851 | Background | Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001. |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |