Extrait

Background and study aims Cardiovascular diseases (CVD), including heart disease, heart attack and stroke, are a major cause of suffering and disability in many patients. Therefore, there is an urgent need for treatment strategies to prevent CVD, especially in healthy individuals at high risk for CVD. Decades of research have shown that CVD results from multiple risk factors, including smoking, high blood cholesterol, high blood pressure, obesity, chronic stress and depression. Treatment strategies for single risk factors are available, but, until now, only very few studies have targeted all of the aforementioned risk factors at the same time in a larger sample of healthy individuals at high risk for CVD. This study aims to fill this gap. The aim of this study is to find out whether the PreFord intervention reduces the risk of CVD. Who can participate? Adults with no evidence of existing CVD, but at high risk for CVD in the future What does the study involve? Participants are randomly allocated to either the PreFord intervention or routine care by their GPs. The PreFord intervention consists of 75 hours (total), divided into 30 sessions (2.5 hours each), two times a week, over a period of 15 weeks. It includes health education (e.g., the heart and vessels, healthy food, heart medication, etc), exercise, a smoking cessation programme if necessary, and LifeSkills, an approach to enhance stress resilience and social relationships at work and leisure time. The intervention is accompanied by a guideline-based drug treatment for high blood cholesterol and high blood pressure, if necessary. Well being, health behaviour and CVD risk factors are assessed before and after the intervention, and annually for 5 years. The intervention and each follow up assessment are free of charge, and participants are free to join or leave the study whenever they wish. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? German Sports University Cologne When is the study starting and how long is it expected to run for? August 2004 to July 2013 Who is funding the study? Bayer Vital (Germany), Pronova BKK (Germany) and AstraZeneca (Germany) Who is the main contact? Prof Hans-Georg Predel [email protected]

Critère d'inclusion

• Prevention of cardiovascular disease

Liens

• isrctn
• ictrp