Lupus Intervention for Fatigue Trial (LIFT)
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|ClinicalTrials.gov Identifier: NCT02653287|
Recruitment Status : Not yet recruiting
First Posted : January 12, 2016
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Physical Activity Lupus Erythematosus, Systemic||Behavioral: Experimental Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Lupus Intervention for Fatigue Trial|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
The experimental intervention is a unique combination of four individual counseling sessions based in motivational interviewing and six group educational sessions 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 and group sessions for a caseload of participants. There are no drugs involved in the intervention.
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. Participants receive 6 consecutive monthly group sessions, beginning shortly after randomization focusing on the following topics: introduction to physical activity; fruits/vegetables; motivation; lifestyle physical activity; healthy diet; and enhancing your environment. The 1 hour sessions are interactive so participants can share information and support each other.
Active Comparator: Control
The control group intervention will receive six group educational sessions focusing on SLE disease management. A nurse practitioner will be responsible for conducting the group sessions.Control arm participants will also receive four individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting approximately 10-15 minutes.
The control group will receive 6 group educational sessions focusing on SLE disease management. Topics include: what is lupus, laboratory tests, medications, taking charge of your health care and managing stress (2 sessions). Sessions will be didactic followed by a brief question and answer period and last about 1 hour. A nurse practitioner will be responsible for conducting the group sessions. Control arm participants receive 4 individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting about 10-15 minutes. They occur shortly before first group session, then at 1.5, 3, and 6 months.
- Change in Fatigue Severity Scale over time [ Time Frame: Baseline, 3, 6, 12 months ]Online questionnaire
- Change in Physical Activity Scale over time [ Time Frame: Baseline, 3, 6, 12 months ]Accelerometry
- Change in International Physical Activity Questionnaire (IPAQ) over time [ Time Frame: Baseline, 3, 6, 12 months ]Phone Interview Questionnaire
- Change in Nutrition Data Systems for Research (NDSR) over time [ Time Frame: Baseline, 6, 12 months ]Dietary Recall Interview
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653287
|Contact: Karen Mancera Cuevas, MS, MPHfirstname.lastname@example.org|
|Contact: Linda Ehrlich-Jones, PhD, RNemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Rosalind Ramsey-Goldman, MD, DrPH||Northwestern University|