Planning Activity and Nutrition Trial in Lupus to Energize and Renew

描述(由申请人提供)：系统性红斑狼疮(SLE)是一种以明显炎症为特征的系统性自身免疫性疾病，在美国影响多达150万人(1)。虽然自20世纪70年代以来，系统性红斑狼疮患者的超额死亡率有所下降(2)，但发病率的一个主要持续原因是慢性、衰弱的疲劳(3)，它显著降低了生活质量(4-6)，增加了工作残疾的风险(7)和相关的卫生保健费用(8)。因此，疲劳是一个频繁而普遍的问题，对SLE患者来说，治疗选择有限，会产生不良后果。在SLE患者的管理中，一个迫切的、尚未得到满足的需求是确定有效的策略来减少疲劳(1)。我们重点关注体力活动和饮食摄入作为潜在的生活方式可改变的行为，以帮助控制体重和减少SLE患者的疲劳，我们建议仿照成功的糖尿病预防计划(9)开展强化行为咨询计划，以评估改变体力活动和饮食对SLE患者疲劳的影响。至 为了解决狼疮患者的这一管理缺口，我们提出了一项计划拨款，用于“狼疮活动和营养试验，以激励和更新”，鹿角。未来的申请将为拟议的临床试验申请资金，等待成功的规划阶段。目前的U34应用程序将支持拟议的临床试验的开发，鹿角利用我们正在进行的NIAMS资助的R21S、R21 AR059989(狼疮中的活动，以激励、更新、改变)和1 R21 AR062317(JointADenture：工作场所活动-慢性膝关节疼痛的饮食干预)的初步数据，NINR资助的K23 NR012225(关节炎的激励访谈和身体活动行为改变)，NIDDK资助的RC1DK087126，E-Networks指导坚持锻炼和饮食的目标(从事)，以及NHLBI资助的R01HL076451(Make Better Choices Study 2，MBC2)。U34应用的具体目标包括：1)为U01拟议的临床试验制定研究方案；2)修订JOINT鹿角风险干预方案；3)开发鹿角控制手臂的教育模块；4)准备U01鹿角应用程序；5)开发鹿角操作手册(MOP)、表格和数据系统、智能手机应用程序以及鹿角培训材料；6)编写人体保护文件，制定鹿角数据安全监测计划。未来U01临床试验(鹿角)应用的初步具体目标包括：1.测试鹿角干预对SLE减少疲劳的有效性，主要结果；2.测试鹿角干预对SLE改变体力活动和饮食行为的有效性，次要结果。

DESCRIPTION (provided by applicant): Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterized by pronounced inflammation that affects up to 1.5 million persons in the US (1). While excess mortality has decreased in patients with SLE since the 1970s (2), a major ongoing cause of morbidity is chronic, debilitating fatigue (3) that significanty decreases quality of life (4-6), and increases risk of work disability (7) and associated health care costs (8). Thus, fatigue is a frequent and pervasive problem with adverse consequences for patients with SLE for which there are limited treatment options. An urgent, unmet need in the management of patients with SLE is identification of effective strategies to decrease fatigue (1). We focus on physical activity and dietary intake as potential lifestyle modifiable behaviors to help control weight and reduce fatigue in patients with SLE and we propose an intensive behavioral counseling program modeled after the successful Diabetes Prevention Program (9) to evaluate the effect of changes in physical activity and diet on fatigue in patients with SLE. To address this management gap for patients with lupus, we propose a planning grant for the "Activity and Nutrition Trial in Lupus to Energize and Renew", ANTLER. A future application will request funding for the proposed clinical trial pending a successful planning phase. The current U34 application will support the development of a proposed clinical trial, ANTLER leveraging preliminary data from our ongoing NIAMS funded R21s, R21 AR059989 (Activity in Lupus to Energize and Renew, ALTER) and 1 R21 AR062317 (JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain), an NINR funded K23 NR012225 (Motivational Interviewing and Physical Activity Behavior Change in Arthritis), an NIDDK funded RC1DK087126, E-Networks Guiding Adherence to Goals for Exercise and Diet (ENGAGED), and an NHLBI funded R01HL076451 (Make Better Choices Study 2, MBC2). The specific aims for this U34 application include: 1) develop study protocol for U01 proposed clinical trial, ANTLER, 2) revise JointADventure intervention for ANTLER intervention arm, 3) develop educational modules for ANTLER control arm, 4), prepare U01 application for ANTLER, 5) develop manual of operations (MOP), forms and data systems, smartphone application, and training materials for ANTLER, and 6) prepare Human Subjects Protection Documents and Develop Data Safety Monitoring Plan for ANTLER. The preliminary specific aims for the future U01 clinical trial (ANTLER) application include: 1. Test the effectiveness of the ANTLER intervention for SLE to decrease fatigue, the primary outcome, and 2. Test the effectiveness of the ANTLER intervention for SLE to change physical activity and diet behavior, the secondary outcomes.