Effect of Controlling Environmental Risk Factors in Established RA

NCT05198271 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-09-08

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198271 on ClinicalTrials.gov