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Active, Not Recruiting

NCT Number: NCT02653287

Lupus Intervention for Fatigue Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fatigue Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Motor Activity Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holly Milaeger, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • include meeting 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.
  • be able to speak and read English

Exclusion criteria

  • include pregnancy at baseline
  • not meeting inclusion criteria.

Treatment and study plan

Experimental

Behavioral

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.

Control

Other

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.

Primary outcomes

  1. Change in Fatigue Severity Scale over time

    Time frame: Baseline, 3, 6, 12 months

    Online questionnaire

Secondary outcomes

  1. Change in Physical Activity Scale over time

    Time frame: Baseline, 3, 6, 12 months

    Accelerometry

  2. Change in International Physical Activity Questionnaire (IPAQ) over time

    Time frame: Baseline, 3, 6, 12 months

    Phone Interview Questionnaire

  3. Godin Leisure Time Exercise Questionnaire

    Time frame: Baseline, 6, 12 months

    Phone Interview Questionnaire

Other outcomes

  1. Change in Nutrition Data Systems for Research (NDSR) over time

    Time frame: Baseline, 6, 12 months

    Dietary Recall Interview

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: LIFT

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2016
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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