NCT05198271

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2022

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

January 5, 2022

Last Update Submit

September 7, 2023

Conditions

Rheumatoid Arthritis

Keywords

preventionsmokingdietperiodontitisphysical activitystress

Outcome Measures

Primary Outcomes (1)

  • Estimate the effectiveness at 6 months of this program on the overall reduction / correction of risk factors.

    Number of patients for whom at least 2 or 3 risk factors (depending on whether 3 present or 4-5 present at baseline) are corrected / in the process of correction. Risk factors will be considered corrected / in the process of being corrected if: * Weight loss ≥5% of initial weight at 6 months (objective measurement of weight) and / or BMI at 6 months \< 25kg/m² * Complete smoking cessation (declarative assessment) * Correction of sedentary lifestyle with moderate to strong IPAQ AND increase of ≥2,000 steps / day compared to the initial assessment (on average 5 days / 7) (questionnaire and quantified assessment obtained with the pedometer and automatically reported on the platform) * Improvement in periodontal disease scores ≥4 points on 6 teeth assessed according to Ramfjord's recommendation (plaque index (Sillness and Loe index), gingival (Lobene index) and papillary bleeding index) (evaluation by the periodontologist) * Decrease in anxiety score from N class to N-1 class

    6 MONTHS

Secondary Outcomes (5)

  • To assess the acceptability and adherence of RA patients to the intervention program.

    6 MONTHS

  • At least two risk factors (if 3 present at base) or at least three (if 4 or 5 present at base) are corrected / in the process of correction.

    3 MONTHS

  • RA activity

    3 MONTHS, 6 MONTHS

  • Distribution of the different germs of the oral and fecal micobiota and alpha and beta diversity

    3 MONTHS, 6 MONTHS

  • Personality traits assessed by the Minnesota Multiphasic Personality Inventory questionnaire (MMPI)

    MONTH 0

Study Arms (1)

Management of risk factors

EXPERIMENTAL

-6 month program for reduction /correction of risk factors in patient with active RA : 1. Smoking cessation 2. weightloss 3. Increased physical activity 4. Periodontal treatment 5. Decreased anxiety

Other: Management of risk factorsBehavioral: Smoking cessationBehavioral: weightlossOther: periodontal disease treatmentBehavioral: increased physical activityBehavioral: Decreased anxiety

Interventions

Management of risk factorsOTHER

* 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)

Management of risk factors
Smoking cessationBEHAVIORAL

\- 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"

Management of risk factors
weightlossBEHAVIORAL

-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

Management of risk factors
periodontal disease treatmentOTHER

\- 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

Management of risk factors
increased physical activityBEHAVIORAL

\- For patients with low physical activity: Follow-up by level gp session: 45 '/ week for 3 months

Management of risk factors
Decreased anxietyBEHAVIORAL

\- 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

Management of risk factors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • RA (ACR / EULAR 2010 criteria), with an active disease (2.6 \<DAS 28 \<5.1)
  • Basis treatment for at least 3 months and corticoids \<= 10mg / day
  • And at least 3 risk factors among:
  • BMI ≥25 kg / m²
  • Low physical activity (IPAQ short version)
  • Active smoking
  • Periodontitis ( bone loss on dental panoramic)
  • Anxiety ( Beck anxiety Index \> 16)

You may not qualify if:

  • Patient under protective measure or unable to consent
  • Patient for whom a change in basic treatment for RA is planned within 6 months
  • Active cancer
  • Active infection
  • Antibiotic therapy in the previous 3 months
  • No health cover
  • Diabetes
  • Unbalanced psychiatric pathologies
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidSmokingPeriodontitisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehaviorPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Claire DAIEN, MD

    UH of Montpellier

    STUDY DIRECTOR

Central Study Contacts

Claire DAIEN, MD

CONTACT

+33467337794c-daien@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

May 31, 2022

Primary Completion

July 1, 2024

Study Completion

January 1, 2025

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

FR(1)