Weight Loss and Exercise for Communities with Arthritis in North Carolina (WE-CAN)

 描述（由申请方提供）：肥胖是膝关节骨关节炎（OA）的一个可改变的风险因素，减肥是一种有效的非药物治疗，可减轻疼痛。最近，我们确定，在理想的，高度控制的情况下，饮食诱导的体重减轻10%与运动相结合，在减轻疼痛方面明显优于单独干预。与之前的膝关节OA长期减肥和运动试验相比，我们的饮食诱导减肥和运动组在缓解疼痛方面的效果是前者的两倍。我们的突破性结果是否可以推广到不太严格监测的患者队列尚不清楚。因此，政策相关和临床意义的问题是：我们如何能够适应这种成功的解决方案，普遍的公共卫生问题，使其提供了一个具有成本效益的干预，为现实世界的临床和社区环境？本研究旨在开发并证明一种系统的、实用的、具有成本效益的饮食诱导减肥和运动干预的有效性，社区可以实施这种干预，以减轻疼痛并改善膝关节OA患者的其他临床结局。这个务实的社区试验将确定参与者在我们以前的试验中实现的重要益处是否转化为现实世界的设置。 参与者将是820名流动，社区居住，超重和肥胖（BMI = 27 kg/m2）年龄= 50岁的男性和女性，其符合美国流变学学会膝关节OA临床标准，包括一周中大多数天的膝关节疼痛加上以下6项中的至少3项：年龄= 50岁;僵硬< 30分钟/天;捻发音;骨压痛;骨增大;没有明显的温暖。主要目的是确定在具有不同居民（从城市到农村）和社会经济组成的三个北卡罗来纳州县实施的务实的、基于社区的18个月饮食诱导的减肥和运动干预是否显著降低了超重和肥胖膝关节OA成人的膝关节疼痛。次要目的将确定这种干预是否改善自我报告的功能，健康相关的生活质量和流动性。我们将 还通过在膝关节OA的经验证的计算机模拟模型中使用当前试验的数据进行成本效益和预算影响分析，确定这种务实的、基于社区的干预措施的成本效益。 许多治疗膝关节OA患者的医生没有实际的方法来实施减肥和运动治疗。这项研究意义重大，因为它将测试期待已久且急需的社区计划的有效性，该计划将作为城市和农村社区的临床医生和公共卫生官员实施减肥和运动计划的蓝图，旨在减少膝关节疼痛并改善超重和肥胖成人膝关节OA的其他临床结局。

 DESCRIPTION (provided by applicant): Obesity is a modifiable risk factor for knee osteoarthritis (OA), and weight loss is an effective non- pharmacologic treatment to reduce pain. Recently, we determined that under ideal, highly controlled circumstances, a diet-induced weight loss of 10% combined with exercise was significantly better at reducing pain than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our diet-induced weight loss and exercise group was twice as effective at relieving pain. Whether our groundbreaking results can be generalized to less rigorously monitored patient cohorts is unknown. Thus, the policy relevant and clinically significant question is: How can we adapt this successful solution to a pervasive public health problem so that it provides a cost-effective intervention for real-world clinical and community settings? This study aims to develop and to demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention that communities can implement to reduce pain and improve other clinical outcomes in knee OA patients. This pragmatic community-based trial will determine if the important benefits realized by participants in our previous trial translate to rea-world settings. Participants will be 820 ambulatory, community-dwelling, overweight and obese (BMI = 27 kg/m2) men and women aged = 50 years who meet the American College of Rheumatology clinical criteria for knee OA which includes knee pain on most days of the week plus at least 3 of the following 6: age = 50 years; stiffness < 30 min/day; crepitus; bony tenderness; bony enlargement; no palpable warmth. The primary aim is to determine whether a pragmatic, community-based 18-month diet-induced weight loss and exercise intervention implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to an attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, and mobility. We will also establish the cost-effectiveness of this pragmatic, community-based intervention by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA. Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments. This study is significant in that it will test the effectiveness of a long-awaited and much needed community program that will serve as a blueprint for clinicians and public health officials in urban and rura communities to implement a weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA.