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Behavioral Intervention

Lifestyle Coaching for Lupus-Related Fatigue (LIFT Trial)

N/A

Recruiting

Led By Rosalind Ramsey-Goldman, MD, DrPH

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Being at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether coaching sessions focused on physical activity and nutrition can help decrease fatigue for people with lupus.

Who is the study for?

This trial is for adults over 18 with systemic lupus erythematosus (SLE) who meet specific diagnostic criteria. Participants should have a Body Mass Index (BMI) of 18-40, be able to walk short distances and understand English. Pregnant individuals or those not meeting these conditions cannot join.

What is being tested?

The study compares two groups: one receives coaching on physical activity and nutrition, while the other gets calls about SLE self-management education. The goal is to see if the intervention can reduce fatigue and improve exercise habits and diet in SLE patients over a year.

What are the potential side effects?

Since this trial focuses on lifestyle interventions like exercise and nutrition coaching rather than medication, side effects are minimal but may include muscle soreness or dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I meet the criteria for a definite lupus diagnosis.

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I am 18 years old or older.

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I can walk at least the length of a house without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Fatigue Severity Scale over time

Secondary study objectives

Change in International Physical Activity Questionnaire (IPAQ) over time

Change in Physical Activity Scale over time

Godin Leisure Time Exercise Questionnaire

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental

2008

Completed Phase 2

~2200

0 / 3Eligibility criteria met