Coffeng Jennifer K, van der Ploeg Hidde P, Castellano José M, Fernández-Alvira Juan M, Ibáñez Borja, García-Lunar Inés, van der Beek Allard J, Fernández-Ortiz Antonio, Mocoroa Agustín, García-Leal Laura, Cárdenas Evelyn, Rojas Carolina, Martínez-Castro María I, Santiago-Sacristán Silvia, Fernández-Gallardo Miriam, Mendiguren José M, Bansilal Sameer, van Mechelen Willem, Fuster Valentín
Department of Public and Occupational Health, and EMGO+ Institute for Health and Care Research, VU University Medical Center (VUmc), Amsterdam, the Netherlands.
Department of Public and Occupational Health, and EMGO+ Institute for Health and Care Research, VU University Medical Center (VUmc), Amsterdam, the Netherlands.
Am Heart J. 2017 Feb;184:121-132. doi: 10.1016/j.ahj.2016.11.002. Epub 2016 Nov 10.
Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits.
The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care.
We will conduct a randomized controlled trial including middle-aged bank employees from the Progression of Early Subclinical Atherosclerosis cohort, stratified by SAPB (high SAPB n=260, low SAPB n=590). Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care. The program consists of 3 elements: (a) 12 personalized lifestyle counseling sessions using Motivational Interviewing over a 30-month period, (b) a wrist-worn physical activity tracker, and (c) a sit-stand workstation. Primary outcome measure is a composite score of blood pressure, physical activity, sedentary time, body weight, diet, and smoking (ie, adapted Fuster-BEWAT score) measured at baseline and at 1-, 2-, and 3-year follow-up.
The study will provide insights into the effectiveness of a 30-month worksite-based lifestyle program to promote cardiovascular health compared with standard care in participants with a high or low degree of SAPB.
心血管疾病（CVD）是全球主要的死亡原因。动脉粥样硬化是许多心血管疾病事件的根本原因，通过更健康的生活方式预防或减轻亚临床动脉粥样硬化斑块负担（SAPB）可能会带来巨大的公共卫生益处。
本研究旨在描述一项随机对照试验的方案，该试验旨在调查一项为期30个月的基于工作场所的生活方式计划对心血管健康的有效性，该计划针对与标准护理相比具有高或低程度SAPB的参与者。
我们将进行一项随机对照试验，纳入来自早期亚临床动脉粥样硬化进展队列的中年银行员工，按SAPB分层（高SAPB组n = 260，低SAPB组n = 590）。在每个分层中，参与者将按1:1随机分组，接受生活方式计划或标准护理。该计划包括三个要素：（a）在30个月内使用动机性访谈进行12次个性化生活方式咨询，（b）佩戴在手腕上的身体活动追踪器，以及（c）一个升降式办公桌。主要结局指标是在基线、1年、2年和3年随访时测量的血压、身体活动、久坐时间、体重、饮食和吸烟的综合评分（即改良的Fuster-BEWAT评分）。
本研究将提供有关一项为期30个月的基于工作场所的生活方式计划与标准护理相比，对高或低程度SAPB参与者促进心血管健康有效性的见解。
