Worksite Wellness Interventions on Vascular Function, Insulin Sensitivity , HDL

针对血管功能、胰岛素敏感性、HDL 的工作现场健康干预

• 批准号: 7735014
• 负责人: Richard Cannon
• 金额: $ 96.53万
• 依托单位: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7735014
• 关键词: Address; African American; Age; Biological Availability; Biological Markers; Blood; Blood Vessels; Body Size; Body Weight decreased; Businesses; C-reactive protein; Cardiovascular system; Caucasians; Caucasoid Race; Cessation of life; Cholesterol; Counseling; Coupled; Daily; Dietary Intervention; Dietary intake; Eating; Effectiveness; Employee; End Point; Environment; Epidemic; Exercise; Fatty Acids; Fatty acid glycerol esters; Fiber; Food; Health Benefit; Health Care Costs; High Density Lipoprotein Cholesterol; High Density Lipoproteins; Home environment; Hormonal; Hormone replacement therapy; Incentives; Individual; Inflammation; Intake; Intervention; Lipids; Lipoproteins; Macronutrients Nutrition; Measures; Menopause; Minority; Modeling; Nitric Oxide; Nutritional; Obesity; Oral Contraceptives; Overweight; Participant; Pattern; Physical activity; Population; Population Study; Postmenopause; Premenopause; Productivity; Protocols documentation; Public Health; Randomized; Research Personnel; Resistance; Resources; Risk; Risk Reduction; Role; Societies; Structure; Testing; Thinking; Time; Training; United States National Institutes of Health; Wellness Program; Woman; Work; Workplace; adipokines; adiponectin; arterial stiffness; atheroprotective; brachial artery; cardiovascular disorder risk; cardiovascular risk factor; cohort; day; energy balance; fitness; hormone therapy; improved; insulin sensitivity; mortality; nutrition education; oxidation; programs; sedentary; shear stress; size; weight loss intervention

The project has just begun as protocol 08-H-0108. The aims of the study are to address and answer these scientific and public health questions: 1) Are the determinants of endothelial function different when weight loss is achieved in conjunction with improved fitness versus improved fitness alone? For example, does improved insulin sensitivity or reduced levels of C-reactive protein, anticipated with weight loss, add anything to multivariate modeling for endothelial predictors beyond improved fitness alone? Are predictors different for obese versus overweight women? Post-menopausal versus premenopausal? Caucasian versus African-American? 2) Does increased nitric oxide bioavailability (manifest as improved endothelial function) have any role in reducing arterial stiffness, independent of changes in exercise fitness, adiposity, insulin sensitivity, lipid levels, C-reactive protein, adiponectin? Or can arterial compliance improve with improved exercise fitness alone in the absence of improvement in endothelial function? Are there important age interactions? 3) Is there a difference in the relationship of body size to exercise fitness at study entry or after exercise training--with or without weight loss--between Caucasian and African-American women? 4) Does improved fitness with weight loss (versus improved fitness alone) change atheroprotective HDL subparticle composition (HDL2, pre--HDL) and function (resistance to oxidation, protection from inflammation, cholesterol efflux) and if so, are these independent of changes in HDL cholesterol levels, reduction in fat mass, improvement in insulin sensitivity or treatment with hormone therapies (oral contraceptives, hormone replacement therapy)? 5) What magnitude of fat mass reduction is required for increased insulin sensitivity? Any differences between obese versus overweight women? Post-menopausal versus premenopausal? Caucasian versus African-American? 6) Do levels of C-reactive protein in overweight or obese women correlate with other markers of inflammation? Do improved fitness and weight loss reduce levels of C-reactive protein greater than improved fitness alone, and are there correlations with changes in fat mass? With changes in adiponectin? 7) Do the structured exercises change other daily physical activities? Since the exercises typically represent only small amount of time and energy spent during the day, even small compensatory reduction in spontaneous physical activity accumulated over time can significantly alter the effectiveness of the weight loss intervention. Similarly, do the exercises modify the amount or patterns of food intake, enhance or impede continued dietary interventions? How do these components of energy balance interact in different individuals and regulate weight loss? 8) Do nutrition education sessions in combination with physical activity (versus physical activity alone) in the worksite setting result in greater weight loss? 9) Do nutrition education sessions (versus physical activity alone) in the worksite setting result in changes in dietary intake choices (energy, macronutrients, fatty acids, fiber)? The primary endpoint will be measure of endothelial function at baseline and following 6 months of program participation, with comparison of change between subjects randomized to exercise coupled with weight-loss intervention versus those randomized to exercise alone. Secondary endpoints will include comparisons of changes in dietary intake, adiposity, arterial stiffness, lipoprotein metabolites/functionality, insulin sensitivity and markers of inflammation. Secondary endpoints will include comparisons of changes in dietary intake, adiposity, arterial stiffness, lipoprotein metabolites/functionality, insulin sensitivity and markers of inflammation in blood between subjects randomized to exercise coupled with weight-loss intervention versus those randomized to exercise alone, with exploratory analyses of minorities and age/hormonal status interactions.

该项目刚刚开始为协议08-H-0108。该研究的目的是解决和回答这些科学和公共健康问题： 1）当体重减轻与改善的适应性相对于改善适应性时，内皮功能的决定因素是否有所不同？例如，提高的胰岛素敏感性或降低的C反应蛋白水平是否会随着体重减轻而预期，在仅改善适应性的内皮预测因子的多元建模中添加任何东西吗？肥胖女性与超重女性的预测因素有不同吗？绝经后与绝经前？高加索人与非裔美国人？ 2）一氧化氮生物利用度增加（表现为改善的内皮功能）是否在降低动脉僵硬，独立于运动适应性，肥胖，胰岛素敏感性，脂质水平，C反应蛋白，脂联素的变化无关？还是在没有内皮功能改善的情况下仅通过改善运动健身来提高动脉依从性？有重要的年龄互动吗？ 3）在研究进入或运动训练后，身体大小与运动训练的关系是否有差异 - 与白种人和非裔美国妇女之间的体重减轻？ 4) Does improved fitness with weight loss (versus improved fitness alone) change atheroprotective HDL subparticle composition (HDL2, pre--HDL) and function (resistance to oxidation, protection from inflammation, cholesterol efflux) and if so, are these independent of changes in HDL cholesterol levels, reduction in fat mass, improvement in insulin sensitivity or treatment with hormone therapies (oral避孕药，激素替代疗法）？ 5）提高胰岛素敏感性需要多少幅度脂肪质量减少？肥胖与超重女性之间有任何区别吗？绝经后与绝经前？高加索人与非裔美国人？ 6）超重或肥胖女性中的C反应蛋白水平是否与其他炎症标记相关？改善的适应性和体重减轻是否会降低C反应蛋白的水平，仅仅是仅改善适应性，并且与脂肪质量的变化是否存在相关性？随着脂联素的变化吗？ 7）结构化练习会改变其他日常体育锻炼吗？由于这些练习通常仅代表白天花费的少量时间和能量，因此随着时间的推移积累的自发体育锻炼的少量减少也会显着改变减肥干预的有效性。同样，练习是否会改变食物摄入的数量或模式，增强或阻碍持续的饮食干预措施？这些能量平衡的组成部分如何在不同个体中相互作用并调节体重减轻？ 8）与体育锻炼结合营养教育课程（与体育锻炼 仅活动）在工作场所设置中会导致体重减轻？ 9）在工作场所环境中进行营养教育课程（与仅体育锻炼） 导致饮食摄入选择（能量，大量营养素，脂肪酸，纤维）的变化？ 主要终点将是基线和计划参与6个月后的内皮功能的度量，并比较随机运动的受试者之间的变化与减肥干预相比，与单独运动的变化相比。次要终点将包括饮食摄入，肥胖，动脉僵硬，脂蛋白代谢物/功能，胰岛素敏感性和炎症标志物的变化的比较。 次要终点将包括比较饮食摄入，肥胖，动脉僵硬，脂蛋白代谢物/功能，胰岛素敏感性和炎症标记的受试者之间的炎症和炎症标志物的比较，从而随机运动与体重减肥干预相结合，与较小的年龄和年龄相互作用的人单独进行，与那些随机运动相互作用。