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

December 5, 2024 updated by: Bruno Gualano, University of Sao Paulo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bruno Gualano, PhD
  • Phone Number: +551130618789
  • Email: gualano@usp.br

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-010
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Usual Care Group
This group will receive all regular medical care and advice healthy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Risk cardiovascular score
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: 6 months
assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m^2
6 months
Waist circumference (cm)
Time Frame: 6 months
assessed by measuring tape positioned at the midpoint between the last floating vertebra and the iliac crest.
6 months
Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
Time Frame: 6 months
assessed by blood sample analysis and combined to determine lipid profile
6 months
Insulin sensitivity
Time Frame: 6 months
assessed by oral glucose tolerance test (OGTT)
6 months
Systolic and Diastolic blood pressure
Time Frame: 6 months
assessed by auscultatory method with mercury sphygmomanometer
6 months
Physical activity level
Time Frame: 6 months
assessed by thigh-mounted accelerometer (ActivPAL™ micro)
6 months
Food consumption
Time Frame: 6 months
assessed by three 24-hour food recall in non-consecutive days (being one of the days on the weekend)
6 months
Visceral fat
Time Frame: 6 months
assessed by tomography
6 months
Peak oxygen consumption, as assessed by a cardiopulmonary exercise test
Time Frame: 6 months
6 months
Endothelial function
Time Frame: 6 months
assessed by flow-mediated vasodilatation (FMD)
6 months
Disease activity
Time Frame: 6 months
The activity of the disease, which will be impaired by safety, will be assessed by the presence of anti-dsDNA, using the ELISA technique and confirmation by indirect immunofluorescence in Crithidia luciliae and assessed by the questionnaire Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2000). Total score ranges from 0 to 105. Higher scores represent higher disease activity.
6 months
Damage index
Time Frame: 6 months
assessed by Systemic Lupus International Collaborating Clinics/ American College of Rheumatology - Damage Index. Total score range from 0 (no damage) to 46 (maximum damage).
6 months
Global health status
Time Frame: 6 months
assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.
6 months
Patients' perceptions of the intervention
Time Frame: 6 months
assessed by focus group. A semi-structured script composed of open questions about intervention positive and negative points, barriers for physical activity practice and changes in food consumption, perceptions of health improvement or worsening (physical and psychological aspects), well-being, motivation to maintain the changes made, perspectives regarding health and disease.
6 months
Quality of Life assesment assessed by the Short-Form Health Survey-36 (SF36) [followed by its scale information in the Description]
Time Frame: 6 months
maximum score is 100, with higher scores representing better life quality
6 months
Quality of Life assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire ( SLEQOL) [followed by its scale information in the Description]
Time Frame: 6 months
score ranges from 40 to 280 with higher scores represent worst life quality.
6 months
Physical functioning assessed by Timed-Stands
Time Frame: 6 months
evaluates the maximum number of stand-ups that a subject could perform from a standard height (i.e., 45 cm) armless chair within 30 s
6 months
Physical functioning assessed by Timed Up-and-Go
Time Frame: 6 months
evaluates the time required for the subject to rise from a standard arm chair, walk towards a line drawn on the floor three meters away, turn, return, and sit back down again
6 months
Physical functioning assessed by handgrip test
Time Frame: 6 months
Patients will be instructed to squeeze the dynamometer as hard as possible
6 months
Fatigue
Time Frame: 6 months
assessed by Fatigue Scale (FACIT). The final score can vary from 0 to 52, where higher final score representing higher level of fatigue.
6 months
Anxiety
Time Frame: 6 months
assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-A. Total score ranges from 0 to 21. Where higher final score representing higher level.
6 months
Depression
Time Frame: 6 months
assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-D. Total score ranges from 0 to 21. Where higher final score representing higher level.
6 months
Sleep quality assessed by data obtained from Actigraph (Actigraph GT3x)
Time Frame: 6 months
Data from actigraph will come as these measures: Total Sleep Time (hours/day), Sleep Efficiency (%), Sleep Onset Latency (min), and Wake After Sleep Onset (min), and this data will be considered to determine the sleep quality.
6 months
C-reactive protein (PCR)
Time Frame: 6 months
assessed by analysis of blood sample
6 months
Erythrocyte sedimentation rate
Time Frame: 6 months
assessed by analysis of blood sample
6 months
Inflammatory markers (blood biochemistry)
Time Frame: 6 months
assessed by serum cytokines
6 months
Follow-up
Time Frame: Between 7 and 28 months after the completion of the intervention
investigate the long-term effects of the intervention on maintenance of lifestyle behaviors and its effects on health
Between 7 and 28 months after the completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Living well with lupus Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

we can share the individual data of the participants if the request is reasonable

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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