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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

LIFT Trial 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.Check my eligibility

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.See study design

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.

LIFT Trial 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.

LIFT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fatigue Severity Scale over time

Secondary outcome measures

Change in International Physical Activity Questionnaire (IPAQ) over time

Change in Physical Activity Scale over time

Godin Leisure Time Exercise Questionnaire

Other outcome measures

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

LIFT 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

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

917,051 Total Patients Enrolled

Rosalind Ramsey-Goldman, MD, DrPHPrincipal Investigator - Northwestern University

Northwestern Memorial Hospital

Case Western Reserve University School Of Medicine (Medical School)

Rochester Gen Hospital (Residency)

2 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

Experimental (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02653287 — N/A

Physical Activity Research Study Groups: Intervention, Control

Physical Activity Clinical Trial 2023: Experimental Highlights & Side Effects. Trial Name: NCT02653287 — N/A

Experimental (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02653287 — N/A

Physical Activity Patient Testimony for trial: Trial Name: NCT02653287 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the age requirements for this clinical trial extend beyond 35 years old?

"This clinical trial calls for applicants aged 18 to 80. There are a total of 64 trials that aim to help younger individuals, and 343 studies directed towards those over 65 years old."

Answered by AI

Are admissions still open for this medical study?

"Clinicaltrials.gov data indicates that this trial is presently searching for participants and has been since May 1st 2019, the date of its initial posting. It was last updated on March 2nd 2022."

Answered by AI

How many individuals are currently participating in this research experiment?

"Affirmative, according to the information on clinicaltrials.gov this trial is still enrolling patients. It was initiated on May 1st 2019 and last updated March 2nd 2022; it requires 200 participants from two different medical centres."

Answered by AI

What qualifications must a person possess to partake in this clinical research?

"This medical trial is presently seeking 200 enrollees aged 18-80 years old who present with fatigue and fulfill the American College of Rheumatology's classification criteria for Systemic Lupus Erythematosus (at least 4 out 11 ACR classifiers or 3 plus one SLICC criteria) alongside a body mass index between 18 - 40 kilograms per square metre, and have the ability to ambulate distances standard within households (50 feet)."

Answered by AI