Improving control with Activity and Nutrition

通过活动和营养改善控制

• 批准号: 6799319
• 负责人: VIKTOR E. BOVBJERG
• 金额: $ 70.99万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6799319
• 关键词: behavior modification; behavior therapy; behavioral /social science research tag; blood glucose; body composition; cardiovascular disorder risk; clinical research; clinical trials; diabetes education; diabetes risk; dietary control; exercise; health behavior; health care service utilization; human subject; human therapy evaluation; lifestyle; longitudinal human study; noninsulin dependent diabetes mellitus; nutrition; nutrition related tag; obesity; patient oriented research; quality of life; therapy compliance

DESCRIPTION (provided by applicant): Despite strong evidence that diet, exercise, and weight loss can lead to clinically important improvement in risk factors for both micro- and macrovascular disease in people with type 2 diabetes, barriers at the patient, clinician, and health system level have prevented the translation of these findings into practice. The proposed translational study, Improving Control with Activity and Nutrition (ICAN) is a partnership between the University of Virginia and Southern Health Systems, a health plan with enrollees throughout Virginia, to demonstrate that clinically proven lifestyle interventions can be implemented and maintained in settings more typical of those in which a majority of Americans receive care. The proposed study is a two arm randomized clinical trial of the ability of lifestyle case management interventions to improve glycemic control, reduce macro- and microvascular disease risk factors, support health-promoting diet and exercise habits, improve quality of life, and reduce the use of high intensity health care venues, among health plan enrollees with type 2 diabetes who are obese. Participants will be randomly assigned to one of two conditions: 1) the lifestyle case management group, which will receive 6 months of theory-based and demonstrated intensive lifestyle intervention, followed by 36 months of lifestyle case management designed to help participants maintain or enhance their diet and exercise habits; 2) the lifestyle intervention group, which will receive the same intense 6 month intervention, but will not receive ongoing guidance after 6 months (the "lifestyle intervention" group). Both groups will be followed for 42 months. Primary study outcomes are glycemic control (HbA1c), lipid profiles, diet and exercise behavior, and health care utilization; a process evaluation will focus on acceptance of the project by participants and physicians, as well as mechanisms through which the intervention influences behavior change. We hypothesize that the lifestyle case management intervention will result in improved glycemic control and risk factor status, greater maintenance of changes in diet and exercise, and decreased health care utilization, compared to the lifestyle intervention group. The project complements existing primary care for type 2 diabetes; patients will continue to be treated by their regular physicians during the trial. Results will be immediately applicable to a majority of health plans and practices in the U.S.

描述（由申请人提供）： 尽管有很多证据表明，饮食，运动和体重减轻可以导致2型糖尿病患者，患者，临床医生和卫生系统水平的微血管疾病的危险因素在临床上的重要改善，从而阻止了这些发现将这些发现转化为实践。拟议的翻译研究，改善活动和营养的控制（ICAN）是弗吉尼亚大学和南方卫生系统之间的合作伙伴关系，这是一项卫生计划，这是一项与弗吉尼亚州的参与者的卫生计划，以证明可以在临床证明的生活方式干预措施中实施并维持在美国人接受医疗服务的人们更典型的环境中。拟议的研究是一项针对生活方式管理干预措施改善血糖控制，减少宏观和微血管疾病危险因素，支持健康饮食和运动习惯，改善生活质量并减少高强度医疗保健场所的使用，与2型糖尿病的健康计划中减少使用高强度的医疗保健场所的使用的两种手臂随机临床试验。 参与者将被随机分配到两个条件之一：1）生活方式案例管理小组，该小组将获得6个月的基于理论的生活方式，并展示了密集的生活方式干预，然后进行36个月的生活方式案例管理，旨在帮助参与者维持或增强饮食和运动习惯； 2）生活方式干预小组将接受相同的6个月干预，但在6个月后不会获得持续的指导（“生活方式干预”小组）。两组将持续42个月。主要研究结果是血糖控制（HBA1C），脂质谱，饮食和运动行为以及医疗保健利用；过程评估将集中于参与者和医师对项目的接受以及干预影响行为改变的机制。我们假设与生活方式干预组相比，生活方式管理干预措施将改善血糖控制和危险因素状况，更大的维持饮食和运动变化以及减少医疗保健利用率。该项目补充了2型糖尿病的现有初级保健；在试验期间，患者将继续受到常规医生的治疗。结果将立即适用于美国的大多数健康计划和实践