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

 描述(由申请人提供)：肥胖是膝骨性关节炎(OA)的一个可改变的危险因素，减肥是一种有效的非药物治疗，以减轻疼痛。最近，我们确定在理想的、高度可控的情况下，饮食诱导的体重减轻10%结合运动在减轻疼痛方面明显比单独干预要好得多。与之前的膝盖骨关节炎长期减肥和锻炼试验相比，我们的饮食诱导减肥和锻炼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那么严格监控的患者队列尚不清楚。因此，与政策相关且具有临床意义的问题是：我们如何使这一成功的解决方案适用于普遍存在的公共卫生问题，以便为现实世界的临床和社区环境提供具有成本效益的干预？这项研究旨在开发和证明一种系统、实用、成本效益高的饮食诱导减肥和运动干预的有效性，社区可以实施该干预措施来减轻膝骨性关节炎患者的疼痛并改善其他临床结果。这项务实的基于社区的试验将决定参与者在之前的试验中实现的重要好处是否转化为现实世界的环境。参与者将是820名活动的、社区居住的、超重和肥胖(BMI=27公斤/平方米)的男性和女性，他们的年龄=50岁，符合美国风湿病学会关于膝盖骨关节炎的临床标准，其中包括一周中大部分时间的膝部疼痛加上以下6项中的至少3项：年龄=50岁；僵硬；每天30分钟；龟裂；骨质压痛；骨骼增大；没有明显的温暖。主要目的是确定在北卡罗来纳州三个居住(从城市到农村)和社会经济构成不同的县实施的务实的、基于社区的18个月饮食诱导的减肥和运动干预是否与注意对照组相比显著减少患有膝骨性关节炎的超重和肥胖成年人的膝关节疼痛。次要目标将决定这种干预是否改善自我报告功能、与健康相关的生活质量和活动能力。我们会 此外，通过在经过验证的膝骨性关节炎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，建立这种务实的、以社区为基础的干预措施的成本效益。许多治疗膝骨性关节炎的医生没有实际的方法来实施减肥和运动治疗。这项研究具有重要意义，因为它将检验一项期待已久且亟需的社区计划的有效性，该计划将作为城市和乡村社区的临床医生和公共卫生官员实施减肥和锻炼计划的蓝图，旨在减轻膝关节疼痛并改善患有膝骨性关节炎的超重和肥胖成年人的其他临床结果。

 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.