Background The evidence of the long-term effects of multiple lifestyle intervention on cardiovascular risk is uncertain. We aimed to summarize the evidence from randomized clinical trials examining the efficacy of lifestyle intervention on major cardiovascular risk factors in subjects at high cardiovascular risk. Methods Eligible trials investigated the impact of lifestyle intervention versus usual care with minimum 24 months follow-up, reporting more than one major cardiovascular risk factor. A literature search updated April 15, 2020 identified 12 eligible studies. The results from individual trials were combined, using fixed and random effect models, using the standardized mean difference (SMD) to estimate effect sizes. Small-study effect was evaluated, and heterogeneity between studies examined, by subgroup and meta-regression analyses, considering patient- and study-level variables. Results Small-study effect was not identified. Lifestyle intervention reduced systolic blood pressure modestly with an estimated SMD of − 0.13, 95% confidence interval (CI): − 0.21 to − 0.04, with moderate heterogeneity (I2 = 59%), corresponding to a mean difference of approximately 2 mmHg (MD = − 1.86, 95% CI − 3.14 to − 0.57, p = 0.0046). This effect disappeared in the subgroup of trials judged at low risk of bias (SMD = 0.02, 95% CI − 0.08 to 0.11). For the outcome total cholesterol SMD was − 0.06, 95% CI − 0.13 to 0.00, with no heterogeneity (I2 = 0%), indicating no effect of the intervention. Conclusion Lifestyle intervention resulted in only a modest effect on systolic blood pressure and no effect on total cholesterol after 24 months. Further lifestyle trials should consider the challenge of maintaining larger long-term benefits to ensure impact on cardiovascular outcomes.

Background Cardiovascular risk factor control is suboptimal in Europe, including Norway. The present study examined the efficacy of a multimodal primary prevention intervention program based on the existing Norwegian health care system. Methods In this open-label randomized controlled trial, adult patients with elevated cardiovascular risk were randomly assigned to an intervention program including a hospital-based lifestyle course and primary care follow-up or to a control group. The participants were recruited between 2011 and 2015. Primary outcome was change in validated cardiovascular risk scores (NORRISK, NORRISK 2, Framingham, PROCAM) between baseline and follow-up. Secondary outcomes included major cardiovascular risk factors. Results After 36 months the NORRISK score was significantly improved in patients assigned to the intervention group (IG) compared to patients assigned to the control group (CG); absolute difference in mean delta score in the IG (n = 305) compared to mean delta score in the CG (n = 296): -0,92, 95% CI: -1,48 to -0,36, p = 0,001. The results for NORRISK 2, Framingham and PROCAM showed similar significant effects. The secondary endpoints including total cholesterol and blood pressure were only minimally, and non-significantly, reduced in the IG, but the proportion of smokers (p = 0,0028) and with metabolic syndrome (p < 0,0001) were significantly reduced. A limited number of cardiovascular events were observed, IG (n = 9), CG (n = 16). Conclusions In subjects with elevated cardiovascular risk, a newly developed prevention program, combining a hospital-based lifestyle course and primary care follow-up, significantly reduced cardiovascular risk scores after 36 months. This benefit appeared achievable primarily through improvements in metabolic syndrome characteristics and smoking habits.

Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Norwegian health department Background The evidence of the long-term effects of multiple lifestyle intervention on cardiovascular risk is uncertain. We aimed to summarize the evidence from randomized clinical trials examining the efficacy of lifestyle intervention on major cardiovascular risk factors in subjects at high cardiovascular risk. Methods  Eligible trials investigated the impact of lifestyle intervention versus usual care with minimum 24 months follow-up, reporting more than one major cardiovascular risk factor. A literature search updated April 15, 2020 identified 12 eligible studies. The results from individual trials were combined using fixed and random effect models, using the standardized mean difference (SMD) to estimate effect sizes. Small-study effect was evaluated, and heterogeneity between studies examined by subgroup and meta-regression analyses considering patient- and study-level variables. Results  Small-study effect was not identified. Lifestyle intervention reduced systolic blood pressure modestly with an estimated SMD of -0.13, 95% confidence interval (CI): -0.21 to -0.04, with moderate heterogeneity (I² = 59%), corresponding to a mean difference of approximately 2 mmHg (MD = -1.86, 95% CI: -3.14 to -0.57, p = 0.0046). This effect disappeared in the subgroup of trials judged at low risk of bias (SMD = 0.02, 95% CI: -0.08 to 0.11). For the outcome total cholesterol SMD was -0.06, 95% CI: -0.13 to 0.00, with no heterogeneity (I² = 0%), indicating no effect of the intervention. Conclusion  Lifestyle intervention resulted in only a modest effect on systolic blood pressure and no effect on total cholesterol after 24 months. Further lifestyle trials should consider the challenge of maintaining larger long-term benefits to ensure impact on cardiovascular outcomes.