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Randomized Controlled Trial
. 2023 Feb 23:14:1106334.
doi: 10.3389/fendo.2023.1106334. eCollection 2023.

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

Affiliations
Randomized Controlled Trial

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

Christian Brinkmann et al. Front Endocrinol (Lausanne). .

Abstract

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.

Keywords: cardiovascular risk assessment; diabetes; employees; exercise; nutrition.

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Conflict of interest statement

CB is a member of the Abbott Diabetes Care Advisory Board and has received research grants and honoraria from Abbott. GH was employed by the Health Service of the Ford Motor Company GmbH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
Delta values of the European Society of Cardiology – Systematic Coronary Risk Evaluation score (ESC-SCORE) – Intention-to-treat analysis. Means with 95% confidence intervals.
Figure 3
Figure 3
Delta values of the European Society of Cardiology – Systematic Coronary Risk Evaluation score (ESC-SCORE) –Per protocol analysis. Means with 95% confidence intervals.

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