Lupus Intervention for Fatigue Trial (LIFT)

April 7, 2026 updated by: Rosalind Ramsey-Goldman, Northwestern University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60611
        • Holly Milaeger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fatigue Severity Scale over time
Time Frame: Baseline, 3, 6, 12 months
Online questionnaire
Baseline, 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity Scale over time
Time Frame: Baseline, 3, 6, 12 months
Accelerometry
Baseline, 3, 6, 12 months
Change in International Physical Activity Questionnaire (IPAQ) over time
Time Frame: Baseline, 3, 6, 12 months
Phone Interview Questionnaire
Baseline, 3, 6, 12 months
Godin Leisure Time Exercise Questionnaire
Time Frame: Baseline, 6, 12 months
Phone Interview Questionnaire
Baseline, 6, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nutrition Data Systems for Research (NDSR) over time
Time Frame: Baseline, 6, 12 months
Dietary Recall Interview
Baseline, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Rosalind Ramsey-Goldman, MD, DrPH, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimated)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIFT Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It is the intent of all investigators in this project to share any and all resources generated as a result of an award for this project. The final data from this project will be de-identified in accordance with HIPAA guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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