Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus: the Living Well with Lupus Study

NCT04431167 | Completed

• 1 other identifier: Living well with lupus Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This research program aims to investigate the clinical, physiological, metabolic and molecular effects of lifestyle change in patients with systemic lupus erythematosus with high cardiovascular risk. This 6-month parallel-group randomized controlled trial aims to investigate the feasibility and efficacy of a newly developed lifestyle change intervention - through recommendations for structured and unstructured physical activity and healthy eating - on increasing physical activity level and improving eating habits. Potential effects of the intervention on cardiovascular and cardiometabolic risk factors, health-related quality of life, symptoms of anxiety and depression, sleep quality and immune function will be investigated. Gold-standard techniques and a variety of analyses will be performed to access the potential mechanisms involved in response to this intervention.

Conditions

Systemic Lupus Erythematosus

Keywords

Life style; Behavioral intervention; Cardiovascular risk; Life quality

Outcome Measures

Primary Outcomes (1)

• Risk cardiovascular score

  assessed by measures of five standard variables (HDL cholesterol, triglycerides, fasting blood glucose, waist circumference and blood pressure - average of systolic and diastolic blood pressures). Z-score = \[(50 - HDL cholesterol)/sd + (triglycerides - 150)/ sd\] + \[(fasting blood glucose - 100)/ sd\] + \[(waist circumference - 88)/ sd\] + \[(blood pressure - 115)/ sd\]. Higher score values represent higher risk. \*sd: standard deviation. Higher Z-score represent higher risk.

  6 months

Secondary Outcomes (27)

• Body mass index (BMI)

  6 months

• Waist circumference (cm)

  6 months

• Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides

  6 months

• Insulin sensitivity

  6 months

• Systolic and Diastolic blood pressure

  6 months

Study Arms (2)

Living well with Lupus Group

EXPERIMENTAL

A newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.

Behavioral: Living well with Lupus

Usual Care Group

NO INTERVENTION

This group will receive all regular medical care and advice healthy

Interventions

Living well with Lupus BEHAVIORAL

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.

Living well with Lupus Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only female participants will be eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between 18 and 65 years old diagnosed with systemic lupus erythematosus
• 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

You may not qualify if:

• another rheumatic diseases (except for secondary Sjogren's syndrome)
• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (3)

• 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.

  PMID: 40083122 DERIVED

• 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.

  PMID: 38280124 DERIVED

• 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.

  PMID: 37354245 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for performing the blood flow measurement will be blinded to the allocation of groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Experimental group and no intervention group (usual care group)

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: June 16, 2020
• Study Start: December 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: August 28, 2023
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)