NCT04431167

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-02-28
• Completion: 2023-08-28
• First posted: 2020-06-16
• Last updated: 2024-12-11

Locations

1 site across 1 country: Brazil