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和没有干预，将继续导致医疗保健的大幅增加 在美国的成本。需要创新的、大量的项目来应对肥胖症流行。然而，a 文献回顾显示，对于最佳减肥计划还没有达成共识，这导致了对 创新的减肥计划，特别是那些针对服务不足人群的计划。传统提供商- 患者就诊通常涉及一名提供者和一名患者。小组访问模式(也称为共享小组访问) 是一个有多个患者的提供者，患者本身相互提供支持和信息。 这一模型可能是治疗市中心人口肥胖的理想选择，这一假设将在我们的 学习。 也利用过去3年一起开会的利益相关者的反馈和建议 来自POWER(用正确的饮食预防肥胖)项目的初步数据，该项目同意651名肥胖者 MLK-门诊中心的患者在3年的时间里，我们计划测试我们的假设，即负担得起的、广泛的- 具有多个文化敏感成分的可扩展的以患者为中心的肥胖小组治疗方法是 至少与营养师对肥胖的个体化方法一样有效和更可持续。 我们将在5年内进行一项为期18个月的随机试验，测试一个共享的复合体 小组访问方法(450名参与者)，采用个性化营养师主导计划(150名参与者)。我们会 用意向来对待分析。这项研究的两个分支的兴趣点将分别在3、6和 12个月，与基线相比，将包括1)%的患者初始体重下降5% (主要结果)，2)体重变化，3)腰围，4)糖化血红蛋白变化。125名患者的子集， 复合组ARM和营养师引导的ARM中的75名患者将接受冠状动脉钙化扫描 并在基线和干预12个月后测量血管周围脂肪。 我们期望这项研究将回答集体治疗与个体化治疗的有效性问题。 治疗肥胖症的方法，并开发一种可持续治疗未得到充分服务的成年肥胖者的团体访视方法 在常规卫生保健环境中的人口。我们的研究将检验这一治疗肥胖症的独特方法 为医疗保健政策提供信息，帮助遏制肥胖流行的浪潮，降低医疗保健成本。

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.