Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and < 41 kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed. This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis. Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).

中文翻译：

---

更好的膝盖，更好的我™：两项支持膝盖骨关节炎自我管理的可扩展医疗干预措施的有效性–一项随机对照试验的方案

虽然建议对膝盖骨关节炎进行教育，锻炼和减肥，但尚未将减肥策略纳入运动干预措施的其他益处得到充分研究。这项研究的目的是在私人健康保险的情况下，比较以锻炼和自我管理（锻炼干预）为目标的远程交付，循证和理论知情的行为改变干预的临床和成本效果，采用相同的干预措施加上积极的体重管理（锻炼加上体重管理干预措施），以及针对超重或肥胖的膝关节骨关节炎患者的仅作为信息的对照组。三臂，务实的平行设计随机对照试验，涉及415位年龄≥45和≤80岁，体重指数≥28kg / m2和< 41 kg / m2和痛苦的膝盖骨关节炎。整个Medibank私人健康保险成员都在澳大利亚招募。这三类人均可访问定制的网站，其中包含有关骨关节炎和自我管理的信息。锻炼小组的参与者还通过视频会议在六个月内与理疗师进行了六次咨询，包括制定加强锻炼和体育锻炼计划的处方，有关管理的建议以及其他教育资源。运动与体重管理小组在六个月内通过视频会议与营养师进行了六次咨询，除运动小组的干预外，还包括非常低卡路里的生酮饮食，代餐和支持行为改变的资源。在基线，6个月和12个月时测量结果。主要结局是6个月时自我报告的膝盖疼痛和身体功能。次要结果包括体重，体育活动水平，生活质量，总体变化评分，护理满意度，膝盖手术和/或骨科医师的约会以及接受手术的意愿。其他措施包括依从性，不良事件，自我效能和干预成分的有用性。还将评估每种干预措施的成本效益。这项务实的研究将确定将体重管理与运动结合起来的可扩展的远程交付服务是否比仅进行运动以及与仅提供信息的对照组相比都更有效。这些发现将为膝关节骨关节炎患者的远程提供服务的开发和实施提供信息。