Effect of Exercise and Weight Loss on Cardiovascular Health

描述（由申请人提供）：本研究的主要目的是在一项综合行为减肥计划的背景下，检验公共卫生一致推荐的体育活动水平[中等体育活动(MOD-PA) = 150分钟/周]与更高剂量的体育活动[高体育活动(high - pa) = 250分钟/周]的影响，该计划包括使用心脏MRI和血管疾病风险生物标志物减少心血管功能的能量摄入。每一种运动剂量都将独立地与饮食组干预进行比较，以确定主要和次要结果，并将MOD-PA与HIGH-PA进行比较。这项研究招募了390名超重和肥胖的成年人，他们将被随机分配到上述条件之一（饮食，MOD-PA, HIGH-PA），为期12个月。主要和次要结果的评估将在参与干预前的基线、干预最初6个月之后和干预12个月结束时进行。主要结果是通过心脏MRI测量LVM。次要结果包括额外的心脏MRI测量（主动脉脉搏波速度、舒张末期容积、主动脉扩张度）、炎症标志物（CRP和TNF1）和选定的脂肪细胞因子（脂联素）作为血管结局、体重、身体组成和心肺健康相关风险的生物标志物，以及传统的心血管疾病危险因素（血脂、葡萄糖、胰岛素、血压）。额外的次要分析将允许检查独立于体重变化的体力活动对主要和次要结果的影响。

DESCRIPTION (provided by applicant): The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity [moderate physical activity (MOD-PA) = 150 min/wk] versus a higher dose of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. Assessment of the primary and secondary outcomes will occur at baseline prior to participation in the intervention, following the initial six months of the intervention, and at the conclusion of 12 months of the intervention. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNF1) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.