Lupus Intervention for Fatigue Trial

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02653287
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Northwestern University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rosalind Ramsey-Goldman, MD, DrPH
Principal Investigator Affiliation	Northwestern University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fatigue, Physical Activity, Lupus Erythematosus, Systemic

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Holly Milaeger, Chicago, Illinois

Status

Recruiting

Address

Holly Milaeger

Chicago, Illinois, 60611

Site Contact

Holly Milaeger, MPH

[email protected]

312-503-1919

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Dominique Kinnett-Hopkins, PhD

[email protected]

312-503-0869

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