Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

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 1970s, 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.

Preliminary data from lupus patients showed that regular aerobic exercise can improve quality of life and reduce fatigue. 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) this study designed the Lupus Intervention Fatigue Trial (LIFT) to compare the effectiveness of a motivational interviewing program intervention versus a patient educational program control to reduce fatigue in persons with lupus.

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.

ELIGIBILITY CRITERIA:

Inclusion Criteria:

  • Meets at least 4 of 11 American College of Rheumatology (ACR) classification criteria for definite SLE, or 3 out of 11 ACR classification criteria with also meeting at least one SLICC criteria
  • Be at least 18 years of age
  • Have a BMI between 18-40 kg/m2
  • Be able to ambulate at least household distances (50ft)
  • Be able to provide informed consent.

Exclusion Criteria:

  • Include pregnancy at baseline
  • Not meeting inclusion criteria. 

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Treatment

Study Location(s):

Northwestern University, Chicago, Illinois, United States, 60611

Study Website:

https://clinicaltrials.gov/ct2/show/NCT02653287?term=NCT02653287&rank=1

Last Reviewed: 05/06/2019