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，协议号为 08-H-0108。该研究的目的是解决和回答以下科学和公共卫生问题： 1) 当减肥与改善体质相结合实现时，与单独改善体质相比，内皮功能的决定因素是否不同？例如，随着体重减轻，胰岛素敏感性的提高或 C 反应蛋白水平的降低是否会为内皮预测因子的多变量模型添加任何作用，而不仅仅是改善健康状况？肥胖女性与超重女性的预测因素是否不同？绝经后与绝经前？白种人和非裔美国人？ 2) 一氧化氮生物利用度的增加（表现为内皮功能的改善）在降低动脉僵硬度方面是否有作用，与运动健康、肥胖、胰岛素敏感性、血脂水平、C反应蛋白、脂联素的变化无关？或者在内皮功能没有改善的情况下，仅通过改善运动健康可以改善动脉顺应性吗？是否存在重要的年龄相互作用？ 3) 在研究开始时或运动训练后（有或没有减肥），白人和非裔美国女性的体型与运动健康的关系是否存在差异？ 4) 通过减肥改善体质（相对于单独改善体质）是否会改变动脉粥样硬化保护性 HDL 亚颗粒成分（HDL2、前 HDL）和功能（抗氧化、防止炎症、胆固醇流出），如果是这样，这些是否与变化无关高密度脂蛋白胆固醇水平、减少脂肪量、改善胰岛素敏感性或激素疗法（口服避孕药、激素替代疗法）？ 5) 增加胰岛素敏感性需要减少多少脂肪量？肥胖女性与超重女性之间有什么区别吗？绝经后与绝经前？白种人和非裔美国人？ 6) 超重或肥胖女性的 C 反应蛋白水平与其他炎症标志物相关吗？改善健康和减肥是否比单独改善健康更能降低 C 反应蛋白水平？与脂肪量的变化是否存在相关性？脂联素的变化？ 7) 结构化练习是否会改变其他日常体育活动？由于锻炼通常只代表一天中花费的少量时间和能量，因此即使随着时间的推移积累的自发身体活动的小补偿性减少也会显着改变减肥干预的有效性。同样，锻炼是否会改变食物摄入量或模式，增强还是阻碍持续的饮食干预？能量平衡的这些组成部分如何在不同个体中相互作用并调节体重减轻？ 8) 将营养教育课程与身体活动相结合（而不是身体活动） 在工作场所环境中单独活动）会导致更大的减肥效果吗？ 9) 在工作场所进行营养教育课程（相对于单独的体育活动） 导致饮食摄入选择（能量、常量营养素、脂肪酸、纤维）发生变化？ 主要终点是测量基线时和参与计划 6 个月后的内皮功能，比较随机接受运动联合减肥干预的受试者与随机接受单独运动的受试者之间的变化。次要终点将包括比较饮食摄入量、肥胖、动脉僵硬度、脂蛋白代谢物/功能、胰岛素敏感性和炎症标志物的变化。 次要终点将包括通过探索性分析，比较随机接受运动结合减肥干预的受试者与随机接受单独运动的受试者之间的饮食摄入量、肥胖、动脉僵硬度、脂蛋白代谢物/功能、胰岛素敏感性和血液炎症标志物的变化。少数群体和年龄/荷尔蒙状态的相互作用。