Lifestyle Coaching for Lupus-Related Fatigue

(LIFT Trial)

Recruiting at 1 trial location

Overseen By Linda Ehrlich-Jones, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 months

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on lifestyle changes, so you may not need to change your medication routine, but it's best to confirm with the trial organizers.

What data supports the effectiveness of this treatment for reducing fatigue in lupus patients?

The Lupus Intervention Fatigue Trial (LIFT) is testing a motivational interviewing program to help people with lupus reduce fatigue by encouraging physical activity and better diet. This approach has shown promise in other conditions by helping people make healthier lifestyle choices, which can lead to less fatigue. ^{1 2 3 4 5}

Is lifestyle coaching for lupus-related fatigue safe for humans?

The research on the Lupus Intervention Fatigue Trial (LIFT) does not specifically mention safety concerns, suggesting that the motivational interviewing intervention for lifestyle changes is generally considered safe for participants. ^{1 2 3 4 6}

How is the LIFT treatment for lupus-related fatigue different from other treatments?

The LIFT treatment is unique because it uses motivational interviewing, a technique that encourages patients to change their behavior, to help manage fatigue in lupus patients by promoting physical activity and improving diet, rather than relying on medication. ^{1 2 3 7 8}

What is the purpose of this 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.

Research Team

Rosalind Ramsey-Goldman, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Being able to speak and read English

I meet the criteria for a definite lupus diagnosis.

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

Exclusion Criteria

Not meeting inclusion criteria.

Pregnancy at baseline

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individual coaching sessions focusing on physical activity and nutrition or SLE self-management educational sessions

12 months

4 individual sessions

Follow-up

Participants are monitored for changes in fatigue, physical activity, and dietary behavior

12 months

Assessments at baseline, 3, 6, and 12 months

Treatment Details

Interventions

• Control
• Experimental

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

In a study of 515 systemic lupus erythematosus (SLE) patients, factors such as Caucasian ethnicity, pain levels, abnormal illness-related behaviors, and feelings of helplessness were linked to increased fatigue, highlighting the importance of psychological and social factors in managing fatigue.

Interestingly, traditional SLE-specific measures like disease activity and damage did not correlate with fatigue levels, suggesting that interventions to reduce fatigue should focus on addressing pain and psychological well-being rather than just disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. Burgos, PI., Alarcón, GS., McGwin, G., et al.[2022]

The Lupus Intervention Fatigue Trial (LIFT) is a randomized controlled trial involving 236 participants aimed at reducing fatigue in individuals with systemic lupus erythematosus (SLE) through a six-month motivational interviewing program compared to an educational control.

The primary outcome of the study is the change in fatigue levels measured by the Fatigue Severity Score after six months, with additional assessments of physical activity and dietary adherence, which will help develop future strategies for managing fatigue in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. Kinnett-Hopkins, D., Ehrlich-Jones, L., Chmiel, JS., et al.[2023]

In a study of 81 patients with systemic lupus erythematosus (SLE), disease status was found to be a direct predictor of fatigue, indicating that managing the underlying disease may help reduce fatigue levels.

Helplessness and depression were identified as mediating factors between disease status and fatigue, but over time, disease status remained the sole predictor of fatigue, highlighting the importance of addressing the disease itself for effective fatigue management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease status predicts fatigue in systemic lupus erythematosus. Tayer, WG., Nicassio, PM., Weisman, MH., et al.[2006]

In a study of 344 patients with systemic lupus erythematosus, factors such as longer disease duration, higher disease activity, and shorter travel distance to medical centers were identified as predictors of noncompliance with study visits.

Understanding these baseline characteristics can help develop targeted interventions to improve patient compliance in lupus cohort studies, potentially enhancing the quality of research outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic lupus erythematosus in three ethnic groups. XVIII. Factors predictive of poor compliance with study visits. Uribe, AG., Alarcón, GS., Sanchez, ML., et al.[2022]

The WELL study successfully enrolled 168 African-American women with systemic lupus erythematosus (SLE) into a 6-week Chronic Disease Self-Management Program (CDSMP), achieving a 75% completion rate despite challenges in participant registration and attendance.

Key strategies for improving recruitment and retention included scheduling sessions on weekends, providing transportation services, and maintaining frequent contact with participants, which resulted in a high retention rate of 92.3% for the 6-month follow-up survey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming barriers to recruitment and retention of African-American women with SLE in behavioural interventions: lessons learnt from the WELL study. Drenkard, C., Easley, K., Bao, G., et al.[2022]

Designing randomized controlled trials (RCTs) for systemic lupus erythematosus (SLE) is challenging due to the variability of disease symptoms and the inadequacy of existing disease activity indices, which were not specifically designed for RCT outcomes.

The medical outcomes survey short form-36 (SF-36) has been shown to better reflect the effects of SLE and correlate with disease activity, treatment intensity, and patient outcomes, suggesting it could be a valuable tool in assessing treatment efficacy in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial design in systemic lupus erythematosus: lessons learned and future directions. Strand, V.[2017]

Women with systemic lupus erythematosus (SLE) experience significantly greater fatigue compared to women from the general population, with sleep problems and depression playing key roles in this fatigue.

The study supports a model where sleep issues and depression mediate the relationship between lupus disease activity and fatigue, suggesting that effective treatment should target these factors alongside managing disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contributions of disease activity, sleep patterns, and depression to fatigue in systemic lupus erythematosus. A proposed model. McKinley, PS., Ouellette, SC., Winkel, GH.[2019]

A randomized controlled trial involving 80 patients with systemic lupus erythematosus showed that web-based education and counseling significantly improved self-efficacy, fatigue levels, and satisfaction with chronic illness care in the experimental group after six months.

The study highlights the potential of web-based interventions to enhance patient outcomes, suggesting that similar approaches could be beneficial for other patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care. Kankaya, H., Karadakovan, A.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Disease status predicts fatigue in systemic lupus erythematosus. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Systemic lupus erythematosus in three ethnic groups. XVIII. Factors predictive of poor compliance with study visits. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Overcoming barriers to recruitment and retention of African-American women with SLE in behavioural interventions: lessons learnt from the WELL study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Clinical trial design in systemic lupus erythematosus: lessons learned and future directions. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

The contributions of disease activity, sleep patterns, and depression to fatigue in systemic lupus erythematosus. A proposed model. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care. [2021]