Pragmatic Trial of Technology-Supported Behavioral Obesity Treatment in the Primary Care Setting: A Multiphase Effectiveness and Implementation Hybrid Design

项目摘要/摘要 行为肥胖治疗在临床上产生了显著的减肥效果；为了产生最大的影响，它应该是 在初级保健环境中提供，在那里可以接触到许多超重/肥胖患者。我们 开发了一个为期3个月的自动在线行为减肥计划，Rx Weight Lost(RxWL)，以及 结果表明，它在初级保健患者中产生了临床上显著的体重减轻。我们早期的努力是在 RxWL的实际实现一直很有希望，并揭示了与以下相关的挑战 执行情况，以及研究较长期效力的必要性。因此，我们建议进行务实的 提高行为型肥胖干预的实施性和有效性研究 和具有代表性的医疗保健环境。我们正在与罗德岛初级保健医生合作 公司(RIPCPC)，一个由58家诊所、100名医生和16名护士组成的大型初级保健网络 经理们。使用有效性-实施混合设计框架，我们将同时瞄准 有效性和实施，以最大限度地提高我们的研究对公众健康的影响。我们将随机分配 16名护士护理经理中的一半，以及他们所服务的做法，到基本实施(在 电子病历[EMR]以将符合条件的患者定向到RxWL)，或增强的实施(警报、 临床医生技能培训，以激励和支持减肥，临床医生仪表板，报告患者进展 以及促进患者参与和行为改变的工具)。我们将检验这样的假设：增强的 实施将增加患者定向、登记和完成减肥的比例 程序。由于保持减肥是一个关键问题，这个项目还将涉及随机化的 600名超重/肥胖和2型糖尿病、高血压和/或高胆固醇血症患者增加到3人 月RxWL干预，然后是以下三种维护条件之一：(A)控制-9个月在线 教育课程；(B)每月课程和反馈--每月9节在线视频课程，教授自律 对自我监测记录进行自动反馈；(C)更新活动--9个月的在线视频 课程，教授自律，并提供两个为期4周的课程，提供新颖的策略和行为 改善长期结果的挑战。我们将检验这一假设，即12个月的减重效果更好 与每月的课程和反馈相比，有更多的更新活动，两者都比控制好。次要的 结果包括体重的变化，心血管危险因素，以及整整24个月的药物使用。 我们的项目具有重大意义和创新性，因为：它使用了一种经过经验验证的方法来治疗肥胖 整合到初级保健环境中的治疗，利用现有工作人员和EMR能力；它具有 双重注重提高有效性和执行力；它与大型 治疗不同患者群体的初级保健网络；它具有提供可扩展、 可持续的方法，可作为更广泛传播肥胖治疗干预的典范。

PROJECT SUMMARY/ABSTRACT Behavioral obesity treatment produces clinically significant weight loss; for the greatest impact, it should be made available in the primary care setting where it can reach the many patients with overweight/obesity. We have developed a 3-month automated online behavioral weight loss program, Rx Weight Loss (RxWL), and shown that it produces clinically significant weight losses among primary care patients. Our early efforts at pragmatic implementation of RxWL have been promising, and have shed light on challenges associated with implementation, and the need to study longer-term effectiveness. We therefore propose to conduct a pragmatic study to improve the implementation and effectiveness of this behavioral obesity intervention delivered in routine and representative healthcare settings. We are partnering with the Rhode Island Primary Care Physicians Corporation (RIPCPC), a large primary care network of 58 practices with 100 physicians and 16 nurse care managers. Using the framework for Effectiveness-Implementation Hybrid Designs, we will simultaneously target effectiveness and implementation to maximize the public health impact of our research. We will randomly assign half of the 16 nurse care managers, and the practices they serve, to either Basic Implementation (alerts in the electronic medical record [EMR] to direct eligible patients to RxWL), or to the Enhanced Implementation (alerts, clinician skills training to motivate and support weight loss, clinician dashboard with reports on patient progress and tools to facilitate patient engagement and behavior change). We will test the hypothesis that the Enhanced Implementation will increase the proportion of patients directed to, enrolling, and completing the weight loss program. Because maintenance of weight loss is a critical problem, this project will also involve randomization of 600 patients with overweight/obesity and type 2 diabetes, hypertension, and/or hypercholesterolemia to the 3 month RxWL intervention followed by one of three maintenance conditions: (a) Control- 9 monthly online education sessions; (b) Monthly Lessons and Feedback- 9 monthly online video lessons teaching self-regulation with automated feedback on the self-monitoring record; (c) Refresher Campaigns- 9 monthly on-line video sessions, teaching self-regulation and providing two 4-week courses with novel strategies and behavioral challenges to improve long-term outcomes. We will test the hypothesis that 12-month weight losses are better with Refresher Campaigns than Monthly Lessons and Feedback, and both are better than Control. Secondary outcomes include changes in weight, CVD risk factors, and medication use over a full 24 months. Our project is significant and innovative because: it uses an empirically validated approach to obesity treatment that is integrated into the primary care setting, leveraging existing staff and EMR capabilities; it has a dual focus on improving effectiveness and implementation; it has a pragmatic design in partnership with a large primary care network that treats a diverse patient population; and it has potential to it provides a scalable, sustainable approach that can serve as a model for broader dissemination of obesity treatment intervention.