Planned CORR: Planned Care for Obesity and Risk Reduction

描述（由申请人提供）：我们提出了一项随机对照试验，以评估干预措施，肥胖计划护理和风险降低（计划CORR），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。我们将评估它如何在25至70岁的肥胖成年人中创造BMI和代谢，人体测量和行为结果的初始和持续改善，这些肥胖成年人患有以下一种或多种CVRF：高血压，吸烟或代谢综合征。计划的CORR将基于行为改变理论的干预成分与基于慢性护理模型的递送策略（瓦格纳等人，2001;也称为“计划的护理模型”）整合，并且被设计为结合成功地用于治疗肥胖的干预原则，同时支持一种或多种肥胖的管理。 CVRF。计划的CORR旨在与各种初级保健环境兼容，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。在进行前期工作以确保干预成分对预期参与者有用后，我们将招募274名年龄在25-70岁之间的女性和男性，他们符合肥胖的入选标准（I类和II类; BMI 30-39.9）加上一个或多个CVRF。我们预计大约40%将是西班牙裔。计划的CORR是一种分步护理干预，首先是计算机辅助评估和定制的行动计划，医生或护士执业咨询，以及通过每月面对面会议和电话以及每周网络或邮件（基于偏好）教程提供的4个月生活方式改变的密集“第一步”。根据公认的循证方案同时管理CVRF。根据临床反应，连续4个月的步骤包括更多、相同或更少的干预。主要目的是评估与加强常规护理相比，计划CORR在12和24个月时对BMI的影响。次要目标将评价：CVRF结局;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测量。公共卫生相关性：该项目的目的是探讨如何改善基层医疗服务提供者为超重病人提供服务的方式，这些病人还患有其他重要的医疗状况或健康风险，如高血压、吸烟或高胆固醇。由于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团体的健康行为咨询，他们的需求往往没有得到很好的解决。本研究将探讨如何采用系统化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.