Effect of Controlling Environmental Risk Factors in Established RA
NCT05198271 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2023-09-08
Summary
* The factors contributing to the development of rheumatoid arthritis are multiple, with a role of the environment and a predisposing genetic background.
* Among the modifiable environmental factors :unbalanced diet, overweight, low physical activity, smoking, periodontal disease, stress have been identified as risk factors for developing RA.
* By causing low-grade inflammation and stimulation of the immune system (particularly through adipokines, citrullination phenomena and changes in the microbiota), these factors promote the onset of the disease and could also participate in the maintenance of inflammatory processes.
* Thus, obese subjects have more active RA, a lower therapeutic response, and weight loss is associated with lower disease activity ; sedentary lifestyle is associated with more active RA and increased physical activity has beneficial effects on RA; people who smoke respond less well to treatment; periodontal disease is associated with more active RA and their treatment is associated with a decrease in this activity.
* Finally, different methods having a beneficial impact on stress (mindfulness meditation, yoga, relaxation, etc.) have shown interesting results in patients with RA.
* It is important to note that all of these factors are also associated with an increased cardiovascular risk, the leading cause of death in RA.
* The combination of these factors probably has synergistic effects and it is therefore relevant to propose a correction of all these factors in the same program.
* We have developed a management program for environmental risk factors for RA based with experts including rheumatologists, nutritionists, smoking cessation specialists, periodontal disease specialists and stress specialists.
Conditions
Interventions
- OTHER
-
Management of risk factors
* For all patients: * Online dietician consultation (45 min 1st consultation with set objectives then 15-20 min for the following ones) then proposal of varied weekly menus, adapted to different cultural and social contexts by email and reassessment at M3 and M6 * Clinical and radiographic periodontological evaluation at M0 and M6 by a specialist with dental hygiene advice with delivery of equipment and scaling * Initial teleconsultation with motivational interview by sports doctor / APA (30 min) with evaluation of initial physical activity, search for contraindications and development of a personalized program with aerobic and resistance training. Provision of filmed sessions and digital exercise materials for regular practice at home and self-assessment using data from the accelerometer with automatic online report. * Motivational supports on the MyGoodLife / MyGoodCare platform (weight, food questionnaire, pedometer, tobacco consumption)
- BEHAVIORAL
-
Smoking cessation
\- For active smoking patients: * Tobacco consultations: S0, S4 and S8 then according to the opinion of the tobacco specialist * Nicotine substitutes +/- varenicline according to tobacco consumption * Online notebook to record tobacco consumption and "triggers"
- BEHAVIORAL
-
weightloss
-For overweight or obese patients: Online dietician consultation every 15 days for 3 months, the consultation based on the online filling of food questionnaires and the weight curve
- OTHER
-
periodontal disease treatment
\- For patients with periodontal disease: treatment of periodontal disease (planing, cast splint, tooth avulsion, etc.) between M0 and M3, dental panoramic M0 at inclusion and M6
- BEHAVIORAL
-
increased physical activity
\- For patients with low physical activity: Follow-up by level gp session: 45 '/ week for 3 months
- BEHAVIORAL
-
Decreased anxiety
\- For anxious patients: * Teleconsultation with a psychiatrist specializing in stress management, global assessment, identification of the factors involved and training in the use of cardiac coherence * Delivery of connected equipment for the practice of cardiac coherence
Sponsors & Collaborators
-
University Hospital, Montpellier
lead OTHER
Principal Investigators
-
Claire DAIEN, MD · UH of Montpellier
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-31
- Primary Completion
- 2024-07-31
- Completion
- 2025-01-31
Countries
- France
Study Locations
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