Lifestyle Coaching for Lupus-Related Fatigue

(LIFT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce fatigue in people with systemic lupus erythematosus (SLE), a condition where the immune system attacks healthy tissue. Participants will receive either personalized coaching focused on physical activity and nutrition (known as the Lupus Intervention Fatigue Trial or LIFT) or phone calls about SLE management. The goal is to determine if the coaching can decrease fatigue and improve lifestyle habits. Individuals diagnosed with SLE who can walk at least 50 feet might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving SLE management strategies.

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 prior data suggests that this lifestyle coaching intervention is safe for individuals with lupus-related fatigue?

Research has shown that lifestyle coaching, like the one in this trial, is generally safe. This trial uses motivational interviewing to help people set and achieve goals for exercise and healthy eating. With no drugs involved, side effects are very unlikely.

Studies have found that similar lifestyle coaching programs are well-tolerated. As this trial involves no medicines or surgeries, the risk of harmful events is low. Participants discuss exercise and diet with coaches, both of which are safe and beneficial for overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle coaching intervention for lupus-related fatigue because it focuses on personalized support through motivational interviewing, a technique that encourages positive changes in physical activity and diet. Unlike typical lupus treatments, which often involve medications to manage symptoms, this approach empowers patients with behavioral strategies and goal-setting to improve their daily lives naturally. By having Healthy Lifestyle Coaches guide participants, the intervention offers a tailored, drug-free way to tackle fatigue, which could be a refreshing alternative for those seeking holistic management options.

What evidence suggests that this lifestyle coaching intervention is effective for reducing lupus-related fatigue?

Research shows that lifestyle coaching can help reduce tiredness in people with systemic lupus erythematosus (SLE). In this trial, participants in the experimental arm will receive motivational interviewing during coaching sessions, which studies have found can improve fatigue levels. Participants in earlier trials who received personalized coaching reported feeling less tired. The coaching sessions in this trial will focus on increasing exercise and adopting a healthy diet. These habit changes are believed to help reduce tiredness. Overall, this approach holds promising potential for helping those with SLE feel more energized. ^{1 2 3 4 6}

Who Is on the Research Team?

Rosalind Ramsey-Goldman, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

Being able to provide informed consent

I meet the criteria for a definite lupus diagnosis.

Exclusion Criteria

Not meeting inclusion criteria.

Pregnancy at baseline

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02653287

NCT02653287 | Lupus Intervention for Fatigue Trial This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422000167

The Lupus Intervention Fatigue Trial protocol The primary study outcome is six-month change in fatigue from baseline, assessed by the Fatigue Severity Score (FSS). ... Intervention effectiveness will be ...

3. reporter.nih.gov reporter.nih.gov/search/N8cfm_apNUGTAwExKNvc7g/project-details/9748431

Lupus Intervention Fatigue Trial (LIFT) LIFT is a 12-month phase III randomized, parallel group, single blind 2-arm trial designed to compare the effectiveness of a motivational interviewing program ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35091136/

The Lupus Intervention Fatigue Trial protocol - PubMed - NIH The Lupus Intervention Fatigue Trial (LIFT) is a prospective, randomized controlled trial to assess the effectiveness of a six-month motivational interviewing ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001679

Operational changes to the lupus intervention fatigue trial ... LIFT is an ongoing 12-month phase II randomized, controlled parallel, single-blind two-group trial to compare the effectiveness of a motivational interviewing ...

6. trial.medpath.com trial.medpath.com/clinical-trial/d4ad8b4693b9b734/nct02653287-lupus-intervention-fatigue-trial

Lupus Intervention for Fatigue Trial | MedPath This study is designed to evaluate the LIFT intervention to decreased fatigue (primary outcome), improve physical activity (secondary outcome) and dietary ...