NCT02653287

Lupus Intervention for Fatigue Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management educational sessions.This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Detailed description

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching based in motivational interviewing sessions focusing on physical activity and nutrition while the control group will receive individual calls focusing on SLE self-management. This study is designed to evaluate the LIFT intervention to decreased fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Conditions

• Fatigue
• Physical Activity
• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
BEHAVIORAL	Experimental	The experimental intervention includes 4 individual coaching sessions (initial 1 hour in-person and remaining 10-15 minutes per telephone) designed to identify barriers and supports for physical activity and nutrition using motivational interviewing. They occur shortly after randomization, 1.5, 3, and 6 months. Daily participants monitor their physical activity via the Fitbit Flex and their dietary behavior on a paper diary.
OTHER	Control	The control group will receive four individual phone calls focusing on education for SLE disease management, as well as answering any questions the participants have about the study. Topics include: what is lupus, laboratory tests, medications, taking charge of your health care and managing stress (2 sessions). Each call will last about 10-15 minutes, and occur shortly after randomization, then at 1.5, 3, and 6 months.

Timeline

• Start date: 2019-05-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2016-01-12
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States