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Multifactorial Lifestyle Interventions in the Primary and Secondary Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus—A Systematic Review of Randomized Controlled Trials

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Annals of Behavioral Medicine

Abstract

This systematic review aims to summarize the available randomized trials of multifactorial lifestyle interventions in the primary and secondary prevention of coronary heart disease and type 2 diabetes mellitus. Randomized trials investigating the effects of lifestyle interventions including the elements of diet, physical activity, and stress management in people at increased risk for or with manifest coronary heart disease or type 2 diabetes mellitus were searched for in five electronic database and by citation tracking. Quality was assessed using the Cochrane Collaboration’s risk of bias tool. Exploratory effect size calculations were performed for a variety of laboratory and clinical outcome measures. Twenty-five trials including a total of 7,703 participants met the inclusion criteria. Fifteen trials were in patients with coronary heart disease, seven in patients with type 2 diabetes mellitus, and three on primary prevention. The interventions varied greatly regarding concept, intensity, and providers. Compared to participants in “usual care” control groups, there were no consistent effects on lipid levels and blood pressure and small effects on body mass index and glycated hemoglobin (HbA1c). Composite cardiac event rates were significantly less in the intervention groups of the few trials reporting these outcomes. Mortality was also lower in the intervention groups, but the difference was not statistically significant, and confidence intervals were wide. The evidence base for multifactorial lifestyle interventions is weak. Effects on surrogate measures seem minor, but there may be clinically relevant effects on major clinical endpoints.

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References

  1. Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008;88:1254-1264.

    PubMed  Google Scholar 

  2. Kromhout D. Epidemiology of cardiovascular diseases in Europe. Public Health Nutr. 2001;4:441-457.

    Article  CAS  PubMed  Google Scholar 

  3. Yusuf S, Hawken S, Ounpuu S, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): Case-control study. Lancet. 2004;364:937-952.

    Article  PubMed  Google Scholar 

  4. Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: Secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005;143:659-672.

    PubMed  Google Scholar 

  5. Ketola E, Sipila R, Makela M. Effectiveness of individual lifestyle interventions in reducing cardiovascular disease and risk factors. Ann Med. 2000;32:239-251.

    Article  CAS  PubMed  Google Scholar 

  6. Orozco LJ, Buchleitner AM, Gimenez-Perez G, Roque IF, Richter B, Mauricio D. Exercise or exercise and diet for preventing type 2 diabetes mellitus. Cochrane Database Syst Rev. 2008;(3):CD003054.

  7. Taylor RS, Brown A, Ebrahim S, et al. Exercise-based rehabilitation for patients with coronary heart disease: Systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004;116:682-692.

    Article  PubMed  Google Scholar 

  8. Vitetta L, Anton B, Cortizo F, Sali A. Mind-body medicine: Stress and its impact on overall health and longevity. Ann NY Acad Sci. 2005;1057:492-505.

    Article  CAS  PubMed  Google Scholar 

  9. Higgins JPT, Altman DG. Chapter 8: Assessing the risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. The Cochrane Collaboration; 2008.

  10. Aldana SG, Greenlaw R, Salberg A, Merrill RM, Hager R, Jorgensen RB. The effects of an intensive lifestyle modification program on carotid artery intima-media thickness: A randomized trial. Am J Health Promot. 2007;21:510-516.

    PubMed  Google Scholar 

  11. Cooper H, Booth K, Gill G. Using combined research methods for exploring diabetes patient education. Patient Educ Couns. 2003;51:45-52.

    Article  PubMed  Google Scholar 

  12. Cooper HC, Booth K, Gill G. Patients' perspectives on diabetes health care education. Health Educ Res. 2003;18:191-206.

    Article  CAS  PubMed  Google Scholar 

  13. Edelman D, Oddone EZ, Liebowitz RS, et al. A multidimensional integrative medicine intervention to improve cardiovascular risk. J Gen Intern Med. 2006;21:728-734.

    Article  PubMed  Google Scholar 

  14. Elder C, Aickin M, Bauer V, Cairns J, Vuckovic N. Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Altern Ther Health Medicine. 2006;12:24-30.

    Google Scholar 

  15. Giannuzzi P, Temporelli PT, Maggioni AP, et al. GlObal secondary prevention strategies to limit event recurrence after myocardial infarction: The GOSPEL study. A trial from the Italian Cardiac Rehabilitation Network: Rationale and design. Eur J Cardivasc Prev Rehabil. 2005;12:555-561.

    Article  Google Scholar 

  16. Giannuzzi P, Temporelli PT, Marchioli R, et al. Global secondary prevention strategies to limit event recurrence after myocardial infarction: Results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med. 2008;168:2194-2204.

    Article  PubMed  Google Scholar 

  17. Gould KL, Ornish D, Kirkeeide R, et al. Improved stenosis geometry by quantitative coronary arteriography after vigorous risk factor modification. Am J Cardiol. 1992;69:845-853.

    Article  CAS  PubMed  Google Scholar 

  18. Gould KL, Ornish D, Scherwitz L, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995;274:894-901.

    Article  CAS  PubMed  Google Scholar 

  19. Hofman-Bang C, Lisspers J, Nordlander R, et al. Two-year results of a controlled study of residential rehabilitation for patients treated with percutaneous transluminal coronary angioplasty. A randomized study of a multifactorial programme. Eur Heart J. 1999;20:1465-1474.

    Article  CAS  PubMed  Google Scholar 

  20. Ko SH, Song KH, Kim SR, et al. Long-term effects of a structured intensive diabetes education programme (SIDEP) in patients with Type 2 diabetes mellitus—a 4-year follow-up study. Diabet Med. 2007;24:55-62.

    Article  PubMed  Google Scholar 

  21. Lisspers J, Sundin O, Hofman-Bang C, et al. Behavioral effects of a comprehensive, multifactorial program for lifestyle change after percutaneous transluminal coronary angioplasty: A prospective, randomized controlled study. J Psychosom Res. 1999;46:143-154.

    Article  CAS  PubMed  Google Scholar 

  22. Lisspers J, Sundin O, Ohman A, Hofman-Bang C, Rydén L, Nygren A. Long-term effects of lifestyle behavior change in coronary artery disease: Effects on recurrent coronary events after percutaneous coronary intervention. Health Psychol. 2005;24:41-48.

    Article  PubMed  Google Scholar 

  23. Manchanda SC, Narang R, Reddy KS, et al. Retardation of coronary atherosclerosis with yoga lifestyle intervention. J Assoc Physicians India. 2000;48:687-694.

    CAS  PubMed  Google Scholar 

  24. Michalsen A, Grossman P, Lehmann N, et al. Psychological and quality-of-life outcomes from a comprehensive stress reduction and lifestyle program in patients with coronary artery disease: Results of a randomized trial. Psychother Psychosom. 2005;74:344-352.

    Article  PubMed  Google Scholar 

  25. Michalsen A, Knoblauch NT, Lehmann N, et al. Effects of lifestyle modification on the progression of coronary atherosclerosis, autonomic function, and angina—the role of GNB3 C825T polymorphism. Am Heart J. 2006;151:870-877.

    Article  CAS  PubMed  Google Scholar 

  26. Michalsen A, Lehmann N, Paul A, et al. Long-term effects of a one-year mind-body medicine program in patients with coronary artery disease: Final results of the randomized controlled SAFE-LIFE trial. Forsch Komplementärmed. 2007;14(suppl 1):18.

    Google Scholar 

  27. Nilsson PM, Klasson EB, Nyberg P. Life-style intervention at the worksite—reduction of cardiovascular risk factors in a randomized study. Scand J Work Environ Health. 2001;27:57-62.

    CAS  PubMed  Google Scholar 

  28. Oldenburg B, Martin A, Greenwood J, Bernstein L, Allan R. A controlled trial of a behavioral and educational intervention following coronary artery bypass surgery. J Cardiopulm Rehab. 1995;15:39-46.

    Article  CAS  Google Scholar 

  29. Ornish D, Brown SE, Scherwitz LW, et al. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990;336:129-133.

    Article  CAS  PubMed  Google Scholar 

  30. Ornish D, Scherwitz LW, Billings JH, et al. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998;280:2001-2007.

    Article  CAS  PubMed  Google Scholar 

  31. Ott CR, Sivarajan ES, Newton KM, et al. A controlled randomized study of early cardiac rehabilitation: The sickness impact profile as an assessment tool. Heart Lung. 1983;12:162-170.

    CAS  PubMed  Google Scholar 

  32. P.RE.COR.Group. Comparison of a rehabilitation programme, a counselling programme and usual care after an acute myocardial infarction: Results of a long-term randomized trial. Eur Heart J. 1991;12:612-616.

    Google Scholar 

  33. Sebregts EH, Falger PR, Bär FW, Kester AD, Appels A. Cholesterol changes in coronary patients after a short behavior modification program. Int J Behav Med. 2003;10:315-330.

    Article  PubMed  Google Scholar 

  34. Sebregts EH, Falger PR, Appels A, Kester AD, Bär FW. Psychological effects of a short behavior modification program in patients with acute myocardial infarction or coronary artery bypass grafting. A randomized controlled trial. J Psychosom Res. 2005;58:417-424.

    Article  PubMed  Google Scholar 

  35. Shibayama T, Kobayashi K, Takano A, Kadowaki T, Kazuma K. Effectiveness of lifestyle counseling by certified expert nurse of Japan for non-insulin-treated diabetic outpatients: A 1-year randomized controlled trial. Diabetes Res Clin Prac. 2007;76:265-268.

    Article  Google Scholar 

  36. Sivarajan ES, Bruce RA, Lindskog BD, Almes MJ, Belanger L, Green B. Treadmill test responses to an early exercise program after myocardial infarction: A randomized study. Circulation. 1982;65:1420-1428.

    CAS  PubMed  Google Scholar 

  37. Sivarajan ES, Newton KM, Almes MJ. Limited effects of outpatient teaching and counseling after myocardial infarction: A controlled study. Heart Lung. 1983;12:65-73.

    CAS  PubMed  Google Scholar 

  38. Sundin O, Lisspers J, Hofman-Bang C, Nygren A, Rydén L, Ohman A. Comparing multifactorial lifestyle interventions and stress management in coronary risk reduction. Int J Behav Med. 2003;10:191-204.

    Article  PubMed  Google Scholar 

  39. Toobert DJ, Glasgow RE, Nettekoven LA, Brown JE. Behavioral and psychosocial effects of intensive lifestyle management for women with coronary heart disease. Patient Educ Couns. 1998;35:177-188.

    Article  CAS  PubMed  Google Scholar 

  40. Toobert DJ, Glasgow RE, Radcliffe JL. Physiologic and related behavioral outcomes from the Women's Lifestyle Heart Trial. Ann Behav Med. 2000;22:1-9.

    Article  CAS  PubMed  Google Scholar 

  41. Toobert DJ, Glasgow RE, Strycker LA, et al. Biologic and quality-of-life outcomes from the Mediterranean Lifestyle Program: A randomized clinical trial. Diabetes Care. 2003;26:2288-2293.

    Article  PubMed  Google Scholar 

  42. Toobert DJ, Strycker LA, Glasgow RE, Barrera JM, Angell K. Effects of the mediterranean lifestyle program on multiple risk behaviors and psychosocial outcomes among women at risk for heart disease. Ann Behav Med. 2005;29:128-137.

    Article  PubMed  Google Scholar 

  43. Toobert DJ, Glasgow RE, Strycker LA, Barrera JM, Ritzwoller DP, Weidner G. Long-term effects of the Mediterranean lifestyle program: A randomized clinical trial for postmenopausal women with type 2 diabetes. Int J Behav Nutr Phys Act. 2007;4:1.

    Article  PubMed  Google Scholar 

  44. Vestfold Heartcare Study Group. Influence on lifestyle measures and five-year coronary risk by a comprehensive lifestyle intervention programme in patients with coronary heart disease. Eur J Cardiovas Preven Rehab. 2003;10:429-437.

    Article  Google Scholar 

  45. Wattana C, Srisuphan W, Pothiban L, Upchurch SL. Effects of a diabetes self-management program on glycemic control, coronary heart disease risk, and quality of life among Thai patients with type 2 diabetes. Nurs Health Sci. 2007;9:135-141.

    Article  PubMed  Google Scholar 

  46. Wister A, Loewen N, Kennedy-Symonds H, McGowan B, McCoy B, Singer J. One-year follow-up of a therapeutic lifestyle intervention targeting cardiovascular disease risk. CMAJ. 2007;177:859-865.

    PubMed  Google Scholar 

  47. Young RJ, Taylor J, Friede T, et al. Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: A randomized controlled trial. Diabetes Care. 2005;28:278-282.

    Article  PubMed  Google Scholar 

  48. Yu CM, Li LS, Ho HH, Lau CP. Long-term changes in exercise capacity, quality of life, body anthropometry, and lipid profiles after a cardiac rehabilitation program in obese patients with coronary heart disease. Am J Cardiol. 2003;91:321-325.

    Article  PubMed  Google Scholar 

  49. Yu CM, Lau CP, Chau J, et al. A short course of cardiac rehabilitation program is highly cost effective in improving long-term quality of life in patients with recent myocardial infarction or percutaneous coronary intervention. Arch Phys Med Rehabil. 2004;85:1915-1922.

    Article  PubMed  Google Scholar 

  50. Yu CM, Li LS, Lam MF, Siu DC, Miu RK, Lau CP. Effect of a cardiac rehabilitation program on left ventricular diastolic function and its relationship to exercise capacity in patients with coronary heart disease: Experience from a randomized, controlled study. Am Heart J. 2004;147:e24.

    Article  PubMed  Google Scholar 

  51. Sherwin R, Kaelber CT, Kezdi P, Kjelsberg MO, Thomas HE Jr. The multiple risk factor intervention trial (MRFIT) II. The development of the protocol. Prev Med. 1981;10:402-425.

    Article  CAS  PubMed  Google Scholar 

  52. Orchard TJ, Temprosa M, Goldberg R, et al. The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: The Diabetes Prevention Program randomized trial. Ann Intern Med. 2005;142:611-619.

    CAS  PubMed  Google Scholar 

  53. Conn VS, Valentine JC, Cooper HM. Interventions to increase physical activity among aging adults: A meta-analysis. Ann Behav Med. 2002;24:190-200.

    Article  PubMed  Google Scholar 

  54. Conn VS, Hafdahl AR, Moore SM, Nielsen PJ, Brown LM. Meta-analysis of interventions to increase physical activity among cardiac subjects. Int J Cardiol. 2009;133:307-320.

    Article  PubMed  Google Scholar 

  55. Conn VS, Hafdahl AR, Cooper PS, Brown LM, Lusk SL. Meta-analysis of workplace physical activity interventions. Am J Prev Med. 2009;37:330-339.

    Article  PubMed  Google Scholar 

  56. Conn VS, Hafdahl AR, Brown LM. Meta-analysis of quality-of-life outcomes from physical activity interventions. Nurs Res. 2009;58:175-183.

    Article  PubMed  Google Scholar 

  57. Franz MJ, VanWormer JJ, Crain AL, et al. Weight-loss outcomes: A systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J Am Diet Assoc. 2007;107:1755-67.

    Article  PubMed  Google Scholar 

  58. Dickinson HO, Mason JM, Nicolson DJ, et al. Lifestyle interventions to reduce raised blood pressure: A systematic review of randomized controlled trials. J Hypertens. 2006;24:215-233.

    Article  CAS  PubMed  Google Scholar 

  59. Harrington M, Gibson S, Cottrell RC. A review and meta-analysis of the effect of weight loss on all-cause mortality risk. Nutr Res Rev. 2009;22:93-108.

    Article  PubMed  Google Scholar 

  60. Noar SM, Benac CN, Harris MS. Does tailoring matter? Meta-analytic review of tailored print health behaviour change interventions. Psychol Bull. 2007;133:673-693.

    Article  PubMed  Google Scholar 

  61. Karmisholt K, Gøtzsche PC. Physical activity for secondary prevention of disease. Systematic reviews of randomised clinical trials. Dan Med Bull. 2005;52:90-94.

    PubMed  Google Scholar 

  62. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and elaboration. Ann Intern Med. 2008;148:295-309.

    PubMed  Google Scholar 

  63. Lorig KR, Ritter PL, Laurent DD, Plant K. Internet-based chronic disease self-management. A randomized trial. Med Care. 2006;44:964-971.

    Article  PubMed  Google Scholar 

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Acknowledgment

No other persons have made substantial contributions to this manuscript.

Funding

This work was supported by a grant of the German Ministry of Education and Research (01KG0614). The ministry had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

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Authors and Affiliations

  1. Competence Centre of Complementary Medicine and Naturopathy, Technische Universität München, Kaiserstr 9, 80801, Munich, Germany

    Lucia Angermayr M.Sc., M.P.H., Dieter Melchart M.D. & Klaus Linde M.D.

  2. Institute of General Practice, Technische Universität München, Wolfgangstr 8, 81667, Munich, Germany

    Klaus Linde M.D.

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  1. Lucia Angermayr M.Sc., M.P.H.
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  2. Dieter Melchart M.D.
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Correspondence to Lucia Angermayr M.Sc., M.P.H..

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Angermayr, L., Melchart, D. & Linde, K. Multifactorial Lifestyle Interventions in the Primary and Secondary Prevention of Cardiovascular Disease and Type 2 Diabetes Mellitus—A Systematic Review of Randomized Controlled Trials. ann. behav. med. 40, 49–64 (2010). https://doi.org/10.1007/s12160-010-9206-4

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