Pamela Semanik, Co-Investigator, Rush CON
Rosalind Ramsey-Goldman, Principal Investigator, Northwestern University
National Institute of Arthritis and Musculoskeletal and Skin Diseases
8/1/2018 - 7/31/2023
Systemic lupus erythematosus (SLE, lupus) is a systemic autoimmune disease characterized by pronounced inflammation that affects up to 1.5 million people in the US. While excess mortality has decreased in SLE patients since the 1970's, a major ongoing cause of morbidity in this population is chronic, debilitating fatigue that significantly decreases quality of life, and increases risk of work disability and associated health care costs. An urgent, unmet need in the management of patients with SLE is identification of effective strategies to reduce fatigue. Non-pharmacologic interventions have been recommended as valuable approaches for the treatment of fatigue. Preliminary data from lupus patients reported by us and others showed that regular aerobic exercise can improve quality of life and reduce fatigue, but studies examining how to best promote physical activity (PA) are limited. In considering other lifestyle behaviors, there is limited literature on effects of diet, energy balance, and/or nutrient density in SLE patients, but diet intervention has been favorably associated with managing fatigue in other disorders (e.g., cardiovascular disease and age-related functional decline).
To study the effects of intervening on these two potential modifiable lifestyle behaviors (PA and diet) we designed the Lupus Intervention Fatigue Trial (LIFT), formerly the Activity and Nutrition Trial in Lupus to Energize and Renew (ANTLER), in planning grant (U34 AR064513). LIFT is a 12-month phase III randomized, parallel group, single blind 2-arm trial designed to compare the effectiveness of a motivational interviewing program intervention versus a patient educational program control to reduce fatigue in persons with lupus. Each arm has a 6 month intervention with 6 month follow up. Individually tailored lifestyle counseling using motivational interviewing and 6 monthly group support meetings are designed to increase physical activity and improve diet quality in the intervention arm. The control arm includes four individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting about 10-15 minutes and 6 monthly group educational sessions focusing on SLE symptom management.
Using validated measures, the first two specific aims for the LIFT randomized trial in persons with SLE are: 1) to implement and evaluate the impact of the LIFT intervention on self-reported measures of fatigue using the Fatigue Severity Score (FSS) as the primary outcome; and 2) to evaluate the impact of the LIFT intervention on objective measures of PA, average daily non-sedentary minutes defined by light minutes/day and moderate- vigorous minutes/day, measured objectively by a triaxial accelerometer as the secondary outcome. The third specific aim is exploratory evaluating adherence to the LIFT dietary intervention as assessed by nutrient density and intake of recommended eating pattern and food groups measured by the Health Eating Index (HEI), a calculated composite score from the Nutrient Data System for Research (NDSR), a validated 24-hour dietary recall computerized system.