Planned CORR: Planned Care for Obesity and Risk Reduction

描述(由申请人提供)：我们建议进行一项随机对照试验，以评估一项名为“肥胖和降低风险计划护理”(Planned Care for肥胖&Risk Reducing，Planned Corr)的干预措施在多大程度上支持至少有一个心血管危险因素(CVRF)的成人肥胖的初级保健治疗。我们将评估它在最初和持续改善BMI以及代谢、人体测量和行为结果方面的效果，这些肥胖成年人年龄在25岁到70岁之间，他们有以下一种或多种CVRF：高血压、吸烟或代谢综合征。计划Corr将基于行为改变理论的干预组成部分与基于慢性病护理模式(Wagner et al，2001；也称为“计划护理模式”)的交付策略相结合，旨在纳入成功用于治疗肥胖症的干预原则，同时支持一个或多个 CVRF。计划中的CORR旨在与各种初级保健环境相兼容，包括那些用于患者教育的资源最少的环境，以及大多数肥胖成年人接受常规医疗护理的环境。我们将招募274名年龄在25-70岁、符合肥胖(I&II级；BMI 30-39.9)入选标准的女性和男性，外加一名或多名CVRF。我们预计大约40%的人将是西班牙裔。计划的CORR是一种循序渐进的护理干预措施，从计算机辅助评估和量身定做的行动计划开始，医生或护士从业者进行咨询，并通过每月面对面的会议和电话以及每周的网络或邮件(基于偏好)教程，进行为期4个月的生活方式调整的密集“第一步”。根据公认的基于证据的协议同时管理CVRF。连续4个月的步骤包括更多、相同或更少强度的干预，具体取决于临床反应。主要目的是评估12个月和24个月有计划的COR与加强的日常护理相比对BMI的影响。次级目标将评估：CVRF结果；与肥胖和CVRF相关的生理、代谢、行为和心理社会因素；生活质量和抑郁；患者、提供者和工作人员满意度；以及与初级保健实施相关的过程措施。公共卫生相关性：这个项目的目的是探索如何改善初级保健提供者向超重患者提供服务的方式，这些患者也有其他重要的医疗条件或健康风险，如高血压、吸烟或高胆固醇。因为这些患者需要一个复杂的治疗过程，包括定期使用药物和个人或群体健康行为咨询，他们的需求往往得不到很好的满足。这项研究将探讨如何使用以系统为基础的方法来改善这些服务。

DESCRIPTION (provided by applicant): We propose a randomized controlled trial to evaluate how well an intervention, Planned Care for Obesity & Risk Reduction (Planned CORR), supports primary care treatment of obesity in adults with at least one cardiovascular risk factor (CVRF). We will assess how well it creates initial and sustained improvements in BMI and metabolic, anthropometric and behavioral outcomes in obese adults, age 25 to 70 who have one or more of the following CVRFs: hypertension, smoking or the metabolic syndrome. Planned CORR integrates intervention components based on behavior change theory with a delivery strategy based on the Chronic Care Model (Wagner et al, 2001; also called the "Planned Care Model") and is designed to incorporate intervention principles used successfully to treat obesity while at the same time supporting the management of one or more CVRFs. Planned CORR is intended to be compatible with a variety of primary care settings including those with minimal resources to devote to patient education and where most obese adults receive their usual medical care. After formative work to ensure that intervention components are useful to intended participants, we will recruit 274 women and men, age 25-70 who meet the entry criteria of obesity (Class I & II; BMI 30-39.9) plus one or more CVRFs. We anticipate that approximately 40% will be Hispanic. Planned CORR is a stepped care intervention that begins with computer-assisted assessment and tailored action planning, physician or nurse practitioner counseling, and an intensive "first step" of 4 months of lifestyle modification delivered via monthly in-person sessions and phone calls and weekly web or mail (based on preference) tutorials. CVRFs are managed concurrently according to recognized evidence-based protocols. Successive 4-month steps involve more, the same, or less intensive intervention depending on clinical response. The primary aim is to evaluate the effects at 12 & 24 months of Planned CORR on BMI when compared to enhanced usual care. Secondary aims will evaluate: CVRF outcomes; physiological, metabolic, behavioral, and psychosocial factors related to obesity and CVRFs; quality of life & depression; patient, provider & staff satisfaction; and process measures relevant to implementation in primary care. PUBLIC HEALTH RELEVANCE: The aim of this project is to explore how to improve the way primary care providers provide services to their patients who are overweight and who also have other important medical conditions or health risks such as hypertension, smoking or high cholesterol. Because these patients require a complicated treatment course that includes regular use of medications and individual or group health behavior counseling, their needs are often poorly addressed. This study will explore the use of a systems-based approach to improve these services.