Case-Management & Environmental Support to Sustain Weight Loss & Reduce CHD Risk

描述（由申请人提供）：肥胖在美国是一种流行病，三分之一的成年人肥胖。肥胖对国家的健康和经济产生巨大影响，主要是通过其对冠心病（CHD）风险因素的影响：4个肥胖的美国人中有3个至少有一个CHD风险因素可以通过减肥逆转。在以急性护理为中心的系统中工作，大多数临床医生在帮助患者减肥或防止体重增加方面都不成功。一个有前途的和充分研究的方法是综合护理提供的护士和营养师的情况下经理（CMs）。然而，临床预防服务（包括CM）如果与患者的生活环境隔离提供，可能效果较差，因为患者的生活环境往往会加剧热量过剩和缺乏身体活动。该应用程序利用了我们在开发和传播有效的CM计划方面的广泛专业知识（Heartto Heart，R01 HL 070781）。我们将实施以肥胖为重点的CM计划，重点是既定的行为减肥和维持策略以及基于证据的CHD预防目标。我们还将测试由社区卫生工作者实施的结构化环境支持（ES）的额外好处，这将弥合诊所与患者家庭和社区之间的差距。我们的具体目标是：1）在随机临床试验中实施创新的、基于初级保健的CM和CM+ES干预措施。我们将在圣马特奥医疗中心（SMMC）的健康中心开展本试验，该中心为不同种族的低收入人群提供服务。我们将200名肥胖成年人随机分为常规初级保健组（40名患者）、单纯CM组（80名患者）或CM+ES组（80名患者），这些肥胖成年人至少有一个肥胖相关的CHD风险因素超过18个月。干预患者将接受为期12个月的强化减肥和CHD风险干预，然后进行12个月的维持干预。2)确定CM和CM+ES改善BMI和CHD风险因素的有效性和成本效益，相对于常规护理和彼此。我们的主要假设是，通过CM+ES治疗的患者在24个月内的BMI下降幅度大于CM治疗的患者。3)将受欢迎的干预措施转变为县支持的可持续计划，并探索向其他县和非县系统更广泛传播的机会。基于我们调查结果的商业传播案例对于寻求这项投资至关重要。该项目将开发和测试两种新的护理设计模式，以支持持续减肥。鉴于目前解决肥胖和冠心病风险升高的机制的失败，这些模型有可能为基于初级保健的肥胖服务提供蓝图，以减轻这个国家的肥胖负担，特别是对低收入人群。以医生为基础的初级保健迄今未能解决肥胖流行病。在200例有心脏病危险因素的肥胖患者的随机临床试验中，我们将评估护士和营养师病例管理对体重减轻和体重维持的影响，作为医生护理的辅助手段。此外，我们将测试环境支持策略的增量效益，使用社区卫生工作者帮助患者导航他们的家庭和社区环境，以实现减肥。本项目开发和评估的创新干预模式有可能为成功的基于初级保健的肥胖服务提供蓝图。公共卫生相关性：迄今为止，以医生为基础的初级保健未能解决肥胖流行病。在200例有心脏病危险因素的肥胖患者的随机临床试验中，我们将评估护士和营养师病例管理对体重减轻和体重维持的影响，作为医生护理的辅助手段。此外，我们将测试环境支持策略的增量效益，使用社区卫生工作者帮助患者导航他们的家庭和社区环境，以实现减肥。 本项目开发和评估的创新干预模式有可能为成功的基于初级保健的肥胖服务提供蓝图。

DESCRIPTION (provided by applicant): Obesity is an epidemic in the U.S., with a third of adults obese. Obesity exerts enormous impact on the nation's health and economy largely through its effect on coronary heart disease (CHD) risk factors: 3 in 4 obese Americans have at least one CHD risk factor reversible through weight loss. Working within acute care-centered systems, most clinicians are unsuccessful in helping their patients lose weight or prevent weight gain. A promising and well-studied approach is integrated care delivered by nurse and dietitian case managers (CMs). Nonetheless, clinical prevention services (including CM) may be less effective if provided in isolation from patients' living environments that so often reinforce caloric excess and physical inactivity. This application leverages our extensive expertise in developing and disseminating effective CM programs (Heart to Heart, R01 HL070781). We will implement an obesity-focused CM program that focuses on established behavioral weight loss and maintenance strategies and evidence-based CHD prevention targets. We also will test the additional benefit of structured environmental support (ES) carried out by community health workers that will bridge the gap between the clinic and patients' homes and neighborhood. Our Specific Aims are to: 1) Implement innovative, primary care-based CM and CM+ES interventions in a randomized clinical trial. We will conduct this trial at a San Mateo Medical Center (SMMC) health center serving an ethnically diverse, low-income population. We will randomize 200 obese adults with at least one obesity-related CHD risk factor over 18 months to usual primary care (40 patients), CM alone (80), or CM+ES (80). Intervention patients in will receive an intensive weight loss and CHD risk intervention for 12 months, followed by 12 months of maintenance intervention. 2) Determine the effectiveness and cost-effectiveness of the CM and CM+ES for improving BMI and CHD risk factors, relative to usual care and each other. Our PRIMARY HYPOTHESIS is that patients managed through CM+ES will experience greater reductions in BMI over 24- months than those in CM. 3) Transition the favored intervention to a sustainable program, supported by the County, as well as explore opportunities for broader dissemination to other County and non-County systems. A business case for dissemination based on our findings will be critical in seeking this investment. This project will develop and test two novel models of care design to support sustained weight loss. Given the failure of current mechanisms to address obesity and elevated CHD risk, these models have the potential to provide a blueprint for primary care-based obesity services that can reduce this nation's burden of obesity, especially for low-income populations. Physician-based primary care has thus far failed to address the obesity epidemic. In a randomized clinical trial of 200 obese patients with heart disease risk factors, we will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, we will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services. PUBLIC HEALTH RELEVANCE: Physician-based primary care has thus far failed to address the obesity epidemic. In a randomized clinical trial of 200 obese patients with heart disease risk factors, we will evaluate the impact of nurse and dietitian case management on weight loss and weight maintenance, as an adjunct to physician care. In addition, we will test the incremental benefit of an environmental support strategy using community health workers to help patients navigate their home and neighborhood environments to achieve weight loss. The innovative intervention model developed and evaluated in this project has the potential to provide a blueprint for successful primary care-based obesity services.