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

临床研究项目：肥胖团体访问：解决内城肥胖流行病的新方法

• 批准号: 10349524
• 负责人: THEODORE C FRIEDMAN
• 金额: $ 30.63万
• 依托单位: CHARLES R. DREW UNIVERSITY OF MED & SCI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10349524
• 关键词: Address; Adult; American; Antidiabetic Drugs; Antihypertensive Agents; Arthritis; Body Weight; Body Weight Changes; Body Weight decreased; Body mass index; Clinical; Clinical Research; Consensus; Consent; County; Data; Development; Dietitian; Doctor of Philosophy; Dose; Eating; Effectiveness; Enrollment; Evaluation; Family Physicians; Fatty acid glycerol esters; Feedback; Food; Glycosylated hemoglobin A; Group Therapy; Health Care Costs; Health Policy; Health Services; Healthy Eating; Hypertension; Indigent; Individual; Insulin; Intention; International; Intervention; Lead; Los Angeles; Measurement; Measures; Medical; Mental Depression; Minority; Modeling; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Nurse Practitioners; Obesity; Obesity Epidemic; Participant; Patients; Pharmaceutical Preparations; Physical activity; Physicians; Population; Program Sustainability; Provider; Quality of life; Questionnaires; Research Project Grants; Review Literature; Running; Scanning; Suggestion; Testing; Translational Research; Underserved Population; Uninsured; United States; Visit; Weight; adult obesity; arm; cancer type; cardiovascular disorder risk; coronary artery calcium; coronary calcium scoring; cost effective; fatty liver disease; health care settings; health disparity; high risk; indexing; individualized medicine; inner city; innovation; interest; minority patient; novel; obese patients; obese person; obesity prevention; obesity treatment; outpatient facility; patient oriented; personalized approach; primary outcome; programs; randomized trial; stem; treatment as usual; treatment group; waist circumference; weight loss program

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.

抽象的 肥胖流行已导致且若不干预，将继续导致医疗保健费用大幅增加 在美国的费用。需要创新、大批量的计划来解决肥胖流行问题。然而，一个 文献综述表明，对于最佳减肥方案尚未达成共识，因此迫切需要 创新的减肥计划，特别是那些针对服务不足的人群的计划。传统提供商- 患者就诊通常涉及一名提供者和一名患者。团体拜访模式（也称共享团体拜访） 一个提供者拥有多个患者，患者自己互相提供支持和信息。 该模型可能是治疗内城区人口肥胖的理想选择，这一假设将在我们的研究中得到检验。 学习。 并利用过去 3 年中召开的利益相关者的反馈和建议 作为 POWER（通过正确饮食预防肥胖）计划的初步数据，该计划同意 651 名肥胖者 MLK 门诊中心的患者在 3 年的时间里，我们计划检验我们的假设，即一种负担得起的、广泛的 具有多种文化敏感成分的可扩展的以患者为中心的肥胖群体治疗方法是 至少比营养师针对肥胖问题采取的个体化方法同样有效且更可持续。 我们将在 5 年时间内进行为期 18 个月的随机试验，测试共享复合材料 团体访问方法（450 名参与者）和个性化营养师主导的计划（150 名参与者）。我们将 用意图来对待分析。本研究的两个组的感兴趣终点将在第 3、6 和 12 个月，与基线相比，包括 1) % 的患者，其初始体重减轻了 5% （主要结果），2) 体重变化，3) 腰围，4) HbA1c 变化。 125 名患者的子集 复合组和营养师主导组的 75 名患者将接受冠状动脉钙扫描 基线时和干预 12 个月后的血管周围脂肪测量。 我们期望这项研究能够回答有关团体治疗与个体化治疗的有效性的问题 肥胖症的治疗方法，并制定一种在服务不足的成人肥胖症患者中可持续的团体访问方法 常规医疗保健环境中的人口。我们的研究将检验这种治疗肥胖的独特方法 为医疗保健政策提供信息，帮助遏制肥胖流行趋势并降低医疗保健成本。