Lifestyle intervention reduces risk score for cardiovascular mortality in company employees with pre-diabetes or diabetes mellitus - A secondary analysis of the PreFord randomized controlled trial with 3 years of follow-up.

Aim: To evaluate the effects of a multimodal intervention (including exercise training, psychosocial interventions, nutrition coaching, smoking cessation program, medical care) on the health and long-term cardiovascular disease (CVD) mortality risk of company employees with pre-diabetes or diabetes mellitus (DM) at high CVD risk. Methods: In the PreFord study, German company employees (n=4196) participated in a free-of-charge CVD mortality risk screening at their workplace. Based on their European Society of Cardiology - Systematic Coronary Risk Evaluation score (ESC-SCORE), they were subdivided into three risk groups. High-risk patients (ESC-SCORE≥5%) were randomly assigned to a 15-week lifestyle intervention or usual care control group. Data from patients with pre-DM/DM were analyzed intention-to-treat (ITT: n=110 versus n=96) and per protocol (PP: n=60 versus n=52). Results: Body mass index, glycated hemoglobin, total cholesterol, low-density lipoprotein, triglyceride levels as well as systolic and diastolic blood pressure improved through the intervention (ITT, PP: p<0.001). The ESC-SCORE markedly decreased from pre- to post-intervention (ITT, PP: p<0.001). ESC-SCORE changes from baseline differed significantly between the groups, with the intervention group achieving more favorable results in all follow-up visits 6, 12, 24 and 36 months later (at each time point: ITT: p<0.001; PP: p ≤ 0.010). Conclusion: The study demonstrates the feasibility of attracting employees with pre-DM/DM at high CVD mortality risk to participate in a multimodal lifestyle program following a free CVD mortality risk screening at their workplace. The lifestyle intervention used in the PreFord study shows high potential for improving health of company employees with pre-DM/DM in the long term. ISRCTN23536103.

Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study.

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees ( n = 4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE ≥ 5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. STATISTICAL ANALYSIS: intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).