Aims To investigate the effectiveness of a 3-year worksite lifestyle intervention on cardiovascular metrics and to study whether outcomes are influenced by baseline subclinical atherosclerosis (SA) by non-invasive imaging. Methods and results A randomized controlled trial was performed to compare a lifestyle intervention with standard of care in asymptomatic middle-aged subjects, stratified by SA. The intervention consisted of nine motivational interviews during the first year, followed by three further sessions between Years 1 and 3. The primary outcome was the change in a pre-specified adaptation of the Fuster-BEWAT score (Blood pressure, Exercise, Weight, Alimentation, and Tobacco) between baseline and follow-up Years 1–3. A total of 1020 participants (mean age 50 ± 4 years) were enrolled, of whom 510 were randomly assigned to the intervention and 510 to the control group. The baseline adapted Fuster-BEWAT score was 16.2 ± 3.7 points in the intervention group and 16.5 ± 3.5 points in the control group. At Year 1, the score improved significantly in intervention participants compared with controls [estimate 0.83 (95% CI 0.52–1.15) points]. However, intervention effectiveness decreased to non-significant levels at Year 3 [0.24 (95% CI –0.10 to 0.59) points]. Over the 3-year period, the intervention was effective in participants having low baseline SA [0.61 (95% CI 0.30–0.93) points] but not in those with high baseline SA [0.19 (95% CI –0.26 to 0.64) points]. Conclusion In middle-aged asymptomatic adults, a lifestyle intervention was associated with a significant improvement in cardiovascular health and behavioural metrics. The effect attenuated after 1 year as the intensity of the intervention was reduced. Trial registration ClinicalTrials.gov (NCT02561065).

中文翻译：

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全面的生活方式干预对心血管健康的影响：TANSNIP-PESA 试验

目的 调查为期 3 年的工作场所生活方式干预对心血管指标的有效性，并通过非侵入性成像研究结果是否受基线亚临床动脉粥样硬化 (SA) 的影响。方法和结果 在按 SA 分层的无症状中年受试者中，进行了一项随机对照试验，以比较生活方式干预与护理标准。干预包括第一年的九次动机性访谈，然后是第一年和第三年之间的三个进一步的会议。主要结果是 Fuster-BEWAT 评分（血压、运动、体重、营养）的预先指定适应的变化和烟草）在基线和后续第 1-3 年之间。共招募了 1020 名参与者（平均年龄 50 ± 4 岁），其中 510 人被随机分配到干预组，510 人被随机分配到对照组。干预组的基线适应 Fuster-BEWAT 评分为 16.2 ± 3.7 分，对照组为 16.5 ± 3.5 分。在第 1 年，与对照组相比，干预参与者的得分显着提高 [估计 0.83 (95% CI 0.52–1.15) 分]。然而，干预效果在第 3 年下降至无显着水平 [0.24（95% CI –0.10 至 0.59）点]。在 3 年期间，干预对基线 SA [0.61 (95% CI 0.30–0.93) 点] 的参与者有效，但对基线 SA [0.19 (95% CI –0.26 至 0.64) 点] 的参与者无效. 结论 在无症状的中年成年人中，生活方式干预与心血管健康和行为指标的显着改善相关。随着干预强度的降低，效果在 1 年后减弱。试验注册 ClinicalTrials.gov (NCT02561065)。