Integrated Clinical-Behavioral Interventions to Accomplish Weight Loss

描述（由申请人提供）： 来自功效试验的大量证据，包括霍普金斯大学研究人员进行的几项行为干预试验，都证明减肥是可以实现的。然而，初级保健提供者通常不直接参与干预措施。我们提出了一项 3 组随机试验来确定两种综合临床行为干预措施 (ICBI) 的有效性。参与者将是 300 名患有高血压并接受药物治疗的超重或肥胖患者，他们是两家初级保健诊所的患者。对照组以及两个 ICBI 将接受一项基于证据的计划，以改善高血压控制。一种 ICBI，称为 ICBI-IP，是一种多渠道干预措施，由霍普金斯中心的健康顾问进行亲自访问。这种干预措施与功效试验中测试的传统面对面干预措施类似；然而，为了降低成本并提高效率，一些面对面的联系被其他类型的联系（电话、网络、电子邮件）取代。另一个 ICBI 称为 ICBI-Remote，是一种多渠道干预（电话、网络、电子邮件），无需亲自访问，由领先的疾病管理公司 Healthways, Inc. 训练有素的顾问实施。这项研究工作建立在研究人员之前进行的研究的基础上。这两种 ICBI 都将是理论指导的干预措施，改编自 PREMIER，这是一项功效试验，其中干预措施可降低体重并控制高血压。每个ICBI都将实施完善的行为技术来实现减肥，并且每个ICBI都将使用基于网络的工具来促进咨询师、参与者和临床医生之间的沟通；参与者自我监控；以及咨询师和临床医生的反馈。两个 ICBI 都将积极与初级保健提供者合作。主要结果变量是体重指数，次要结果是高血压控制。两者ICBI都应该减轻重量。关键问题是每个计划的减肥程度。 ICBI-IP 可能比 ICBI-Remote 更大程度地减轻重量。尽管如此，ICBI-Remote 应该更便宜、更灵活。 ICBI-IP 可以在各种环境中实施（例如健康计划、大型诊所），而 ICBI-Remote 的优点是易于“扩展”，也就是说，如果成功，可以快速实施。简而言之，这项转化研究应该为超重或肥胖患者控制体重和改善高血压控制提供科学基础。

DESCRIPTION (provided by applicant): An extensive body of evidence from efficacy trials, including several behavioral intervention trials conducted by the Hopkins investigators, has documented that weight loss is achievable. However, primary care providers typically had no direct involvement in the interventions. We propose a 3 group, randomized trial to determine the effectiveness of two integrated clinical-behavioral interventions (ICBIs). Participants will be 300 overweight or obese individuals with medication-treated hypertension, who are patients at two primary care clinics. The comparison group, as well as both ICBIs, will receive an evidence-based program to improve hypertension control. One ICBI, termed ICBI-IP, is a multi-channel intervention with in-person visits delivered by health counselors at the Hopkins center. This intervention is similar to traditional in-person interventions tested in efficacy trials; however, some in-person contacts are replaced with other types of contacts (telephone, web, email) in order to reduce costs and improve efficiency. The other ICBI, termed ICBI-Remote, is a multi-channel intervention (telephone, web, email) without in-person visits implemented by trained counselors of Healthways, Inc, a leading Disease Management company. This research effort builds upon previous research conducted by the investigators. Both ICBIs will be theory-guided interventions, adapted from PREMIER, an efficacy trial in which interventions lowered weight and controlled hypertension. Each ICBI will implement well-established behavioral techniques to accomplish weight loss, and each will use a web-based tool to facilitate communication among counselors, participants and clinicians; self- monitoring by participants; and feedback by counselors and clinicians. Both ICBIs will actively engage primary care providers. The primary outcome variable will be BMI and the secondary outcome hypertension control. Both ICBI should reduce weight. Critical questions are the extent of weight loss from each program. ICBI-IP might reduce weight to a greater extent than ICBI-Remote. Still, ICBI-Remote should be less expensive and more flexible. ICBI-IP could be implemented in a variety of settings (e.g. wellness programs, large clinics), while ICBI-Remote has the advantage of being readily 'scalable', that is, if successful, it could be rapidly implemented. In short, this translation study should provide the scientific foundation for efforts to control weight and improve hypertension control in overweight or obese medical patients.