Primary prevention of type 2 diabetes by lifestyle modification. Results of the PRAEDIAS prevention program

Large landmark studies, such as the Finnish Diabetes Prevention Study (DPS) and the American Diabetes Prevention Program (DPP) could conclusively show that prevention of type 2 diabetes or a significant delay in the manifestation of diabetes is possible by lifestyle modifications in persons with an increased risk of diabetes. However, the lifestyle interventions in these studies were carried out in a relatively resource-intensive individual setting and measures were employed which are far too costly to be implemented in practice. A group approach is clearly more economical and less resource-intensive. The objective of this prospective, randomized trial was to investigate whether the results of the large, high-quality clinical trials for the prevention of type 2 diabetes could be translated into practical affordable interventions that are deliverable in the real world healthcare system in Germany. The effectiveness of the newly developed Prevention of Diabetes Self-Management Program (PREDIAS) for groups was investigated for people with increased risk of diabetes with respect to a successful weight reduction after 1 year. The PREDIAS group program for lifestyle modification and primary prevention of type 2 diabetes consists of 12 course-hours extending over a period of 12 months. A total of 182 persons with an elevated diabetes risk participated in this study and were randomly assigned to the intervention group (PREDIAS) or the control group (CG). Patients in the CG received written information about diabetes prevention. After 12 months participants in the PREDIAS program achieved a significantly higher average weight loss than the CG (-aEuro parts per thousand 3.8 +/- 5.2 kg versus -aEuro parts per thousand 1.4 +/- 4.0 kg, p = 0.001). Fasting glucose was reduced in the PREDIAS group, whereas it rose slightly in the CG (-aEuro parts per thousand 4.3 +/- 11.3 mg/dl versus 1.8 +/- 13.1 mg/dl, p = 0.001). The duration of physical activity per week was significantly increased in the PREDIAS group than in the CG (46.6 +/- 95.5 min/week versus 17.9 +/- 63.8 min/week, p=0.034). Indicators of a modified eating behavior also showed a significantly greater improvement in PREDIAS than in the CG (cognitive restraint 3.9 +/- 3.8 versus 1.5 +/- 4.7, p = 0.001 and disinhibition -aEuro parts per thousand 1.2 +/- 2.7 versus -aEuro parts per thousand 0.4 +/- 2.6, p = 0.049). There were no significantly greater improvements with regard to lipids or blood pressure in the PREDIAS group compared with the CG. The improvements in the risk factors achieved with the PREDIAS group program were broadly equivalent to the 1 year data of the DPP or the DPS, which were both conducted in an extensive and time-consuming individual setting.