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ACTIVE NOT RECRUITING
NCT02653287
NA

Lupus Intervention for Fatigue Trial

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2019-05-01

Completion Date

2025-12

Last Updated

2025-04-06

Healthy Volunteers

No

Interventions

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.

Locations (2)

Holly Milaeger

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States