Lupus Intervention for Fatigue Trial

Not Applicable

Recruiting

• Conditions: Physical Activity; Lupus Erythematosus, Systemic; Fatigue
• Interventions: Behavioral: Experimental; Other: Control

• Registration Number: NCT02653287
• Lead Sponsor: Northwestern University

Brief 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.

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-12
• Study Start: 2019-05-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Experimental	The experimental intervention is a unique combination of four individual counseling sessions based in motivational interviewing focusing on physical activity, dietary behavior and behavioral strategies. The individual sessions will provide a tailored personalized intervention including problem-solving and goal setting for increasing physical activity, and following a healthy diet. Healthy Lifestyle Coaches (RN or MPH) will be responsible for conducting the individual for a caseload of participants. There are no drugs involved in the intervention.
Control	Control	The control group intervention will receive four individual phone calls checking in with participants regarding questions about the study or from the educational sessions focusing on SLE disease management, each lasting approximately 10-15 minutes.

Primary Outcome Measures

Name	Time	Method
Change in Fatigue Severity Scale over time	Baseline, 3, 6, 12 months	Online questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in Physical Activity Scale over time	Baseline, 3, 6, 12 months	Accelerometry
Change in International Physical Activity Questionnaire (IPAQ) over time	Baseline, 3, 6, 12 months	Phone Interview Questionnaire
Godin Leisure Time Exercise Questionnaire	Baseline, 6, 12 months	Phone Interview Questionnaire

Trial Locations

Locations (2)

Holly Milaeger; 🇺🇸 Chicago, Illinois, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States