Effect of Exercise and Weight Loss on Cardiovascular Health

描述(由申请人提供)：这项研究的主要目的是在综合行为减肥计划的背景下，检验普遍的公共卫生推荐的体力活动水平[中等体力活动(MOD-PA)=150分钟/周]与较高剂量的体力活动[高体力活动(HIGH-PA)=250分钟/周]的影响，该计划包括利用心脏MRI和血管疾病风险的生物标记物减少心血管功能的能量摄入量。这些运动剂量中的每一个都将独立地与仅限饮食的小组干预所提出的主要和次要结果进行比较，MOD-PA也与高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(仅限饮食，MOD-PA，HIGH-PA)，为期12个月。将在参与干预之前、干预最初6个月之后和干预12个月结束时对初级和次要结果进行基线评估。主要结果是心脏MRI测量的LVM。次要结果包括额外的心脏MRI测量(主动脉脉搏波速度、舒张末容量、主动脉扩张性)、炎症标记物(CRP和TNF1)和选定的脂肪细胞因子(脂联素)，作为与血管结果、体重、身体成分和心肺健康相关的风险生物标记物，以及传统的心血管危险因素(血脂、葡萄糖、胰岛素、血压)。额外的二级分析将允许检查与体重变化无关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.