Clinical Research Project:Obesity Group Visits: A Novel Way to Approach the Obesity Epidemic in an Inner-City Setting

摘要 肥胖症的流行已经导致并且如果不进行干预，将继续导致医疗保健的大量增加 在美国的成本。需要创新的、高容量的项目来解决肥胖症的流行。但 文献回顾显示，对于最佳减肥方案没有共识，导致非常需要 创新的减肥计划，特别是那些解决服务不足的人群。传统供应商- 患者访问通常涉及一个提供者与一个患者。团体访问模式（也称为共享团体访问） 是一个提供者与多个病人和病人自己提供支持和信息给对方。 这种模型可能是治疗市中心人群肥胖的理想模型，这一假设将在我们的研究中得到验证。 study. 利用过去三年来共同会见的利益相关者的反馈和建议 这是来自POWER（通过正确饮食预防肥胖）项目的初步数据，该项目同意了651名肥胖者， 患者在MLK门诊中心超过3年的时间，我们计划测试我们的假设，一个负担得起的，广泛的- 一种可扩展的以患者为中心的肥胖症治疗方法，具有多种文化敏感成分， 至少比营养师的个性化肥胖方法更有效，更可持续。 我们将进行一项为期18个月、为期5年的随机试验， 小组访问方法（450名参与者）与个性化的营养师主导的计划（150名参与者）。我们将 使用意向治疗分析。本研究两组的关注终点将在第3、6和 12个月，与基线相比，将包括1）%的患者体重减轻5%的初始体重 （主要结局），2）体重变化，3）腰围，4）HbA 1c变化。125名患者的一个子集， 复合组和营养师组的75名患者将接受冠状动脉钙扫描 以及基线和12个月干预后的血管周围脂肪测量。 我们希望这项研究能够回答关于团体治疗与个体化治疗的有效性的问题 肥胖的方法，并制定一个团体访问的方法，是可持续的，在一个服务不足的成年肥胖 在常规卫生保健环境中。我们的研究将检查这种治疗肥胖的独特方法， 为卫生保健政策提供信息，帮助遏制肥胖流行的趋势，降低卫生保健费用。

Abstract The obesity epidemic has led to and without intervention, will continue to lead to a large increase in health care costs in the US. Innovative, high-volume programs are needed to address the obesity epidemic. However, a literature review reveals that there is no consensus for optimal weight loss programs leading to a great need for innovative weight loss programs, particularly those that address underserved populations. Traditional provider- patient visits usually involve one provider with one patient. The group visit model (also called shared group visit) is one provider with multiple patients and the patients themselves supply support and information to each other. This model may be ideal for treating obesity in an inner-city population, an hypothesis that will be tested in our study. Utilizing the feedback and suggestions from stakeholders who have met together over the past 3 years as well as preliminary data from the POWER (Preventing Obesity With Eating Right) program that consented 651 obese patients at MLK-Outpatient Center over a 3-year period, we plan to test our hypothesis that an affordable, widely- scalable patient-centered group treatment approach to obesity with multiple culturally-sensitive components is at least as effective and more sustainable than an individualized approach to obesity with a dietician. We will perform a randomized trial of 18 months duration over a 5-year period testing either a shared composite group visit approach (450 participants) with an individualized dietician-led program (150 participants). We will use an intention to treat analysis. Endpoints of interest for both arms of this study will be assessed at 3, 6 and 12 months and compared to baseline and will include 1) % of patients who lost 5% of their initial body weight (primary outcome), 2) weight change, 3) waist circumference, 4) change in HbA1c. A subset of 125 patients in the composite group arm and 75 patients in the dietitian-led arm will undergo coronary artery calcium scanning and perivascular fat measurement at baseline and after 12-months of intervention. We expect that this study will answer the question about effectiveness of a group versus individualized treatment approaches for obesity and develop a group visit approach that is sustainable in an underserved adult obese population in a routine health care setting. Our study will examine this unique approach to treating obesity and inform health care policy and help stem the tide of the obesity epidemic and reduce health care costs.