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，SLE患者的过度死亡率有所下降(2)，但发病的一个主要持续原因是慢性，使人衰弱的疲劳(3)，这显著降低了生活质量（4-6），并增加了工作残疾的风险(7)和相关的医疗费用(8)。因此，对于治疗方案有限的SLE患者而言，疲劳是一个常见且普遍存在的问题。在SLE患者的管理中，一个迫切而未被满足的需求是确定有效的策略来减少疲劳(1)。我们关注身体活动和饮食摄入作为潜在的生活方式改变行为，以帮助SLE患者控制体重和减轻疲劳，我们提出了一个模仿成功的糖尿病预防计划(9)的强化行为咨询计划，以评估身体活动和饮食改变对SLE患者疲劳的影响。来

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.