Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus: the Living Well with Lupus Study
NCT ID: NCT04431167
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2020-12-01
2023-08-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Living well with Lupus Group
A newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.
Living well with Lupus
The lifestyle change intervention will involve two constructs: increasing the level of physical activity and improving eating habits, each with its own specific domains and goals. It will be based on a structured program of physical exercises and selection of individualized goals in the domains of transportation, leisure and work to reduce sedentary behavior with the aim of increasing the level of physical activity, as well as establishing changes in dietary aspects, involving consumption domains, structure, behavior and eating attitude using nutritional counseling techniques.
Usual Care Group
This group will receive all regular medical care and advice healthy
No interventions assigned to this group
Interventions
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Living well with Lupus
The lifestyle change intervention will involve two constructs: increasing the level of physical activity and improving eating habits, each with its own specific domains and goals. It will be based on a structured program of physical exercises and selection of individualized goals in the domains of transportation, leisure and work to reduce sedentary behavior with the aim of increasing the level of physical activity, as well as establishing changes in dietary aspects, involving consumption domains, structure, behavior and eating attitude using nutritional counseling techniques.
Eligibility Criteria
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Inclusion Criteria
* one or more high cardiovascular risk factors
* SLEDAI score ≤ 4
* Treatment with prednisone at a dosage \<10 mg/d and treatment with hydroxychloroquine in a stable dose
Exclusion Criteria
* participation in structured exercise training programs and/or prescriptive diets
* illiterate or with diagnosed cognitive disorders or musculoskeletal impairments that potentially compromise understanding and participation in the intervention
18 Years
65 Years
FEMALE
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Bruno Gualano
Professor
Locations
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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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Caruso Mazzolani B, Infante Smaira F, Mendes Sieczkowska S, Romero M, C Santo Andre H, G Pasoto S, de Sa Pinto AL, Rodrigues Lima F, Braga Benatti F, Roschel H, Weber MB, Gualano B. Acceptability and impact of a lifestyle intervention for systemic lupus erythematosus: Qualitative analysis of living well with lupus study. Lupus. 2025 Apr;34(5):474-483. doi: 10.1177/09612033251326986. Epub 2025 Mar 13.
Sieczkowska SM, Mazzolani BC, Smaira FI, Romero M, Pasoto SG, de Sa Pinto AL, Lima FR, De Oliveira VR, Ueda S, Benatti FB, Roschel H, Gualano B. Effects of a lifestyle intervention on cardiovascular risk factors in systemic lupus erythematosus patients: The study "Living well with lupus". Clin Rheumatol. 2024 Mar;43(3):1003-1013. doi: 10.1007/s10067-024-06870-2. Epub 2024 Jan 27.
Sieczkowska SM, Smaira FI, Mazzolani BC, Romero M, Pasoto SG, de Sa Pinto AL, Lima FR, De Oliveira VR, Ueda S, Benatti FB, Roschel H, Gualano B. A randomized controlled trial of an intervention promoting physical activity and healthy eating recommendations in systemic lupus erythematosus: the protocol study "Living Well with Lupus". Rheumatol Int. 2023 Oct;43(10):1799-1810. doi: 10.1007/s00296-023-05370-x. Epub 2023 Jun 24.
Other Identifiers
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Living well with lupus Study
Identifier Type: -
Identifier Source: org_study_id