Lupus Intervention for Fatigue Trial (LIFT)
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|ClinicalTrials.gov Identifier: NCT02653287|
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : September 10, 2020
|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|
|Actual Study Start Date :||May 1, 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 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.
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.
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 group sessions, and educational sessions focusing on SLE disease management, each lasting approximately 10-15 minutes.
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.
- 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: Dominique Kinnett-Hopkins, PhDfirstname.lastname@example.org|
|Contact: Linda Ehrlich-Jones, PhD, RNemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Dominique Kinnett-Hopkins, PhD 312-503-0869 firstname.lastname@example.org|
|Principal Investigator:||Rosalind Ramsey-Goldman, MD, DrPH||Northwestern University|