Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs) (RHUMADIET)

Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Hand Osteoarthritis; Axial Spondyloarthritis

Detailed Description

To investigate in patients having rheumatoid arthritis (RA), or axial spondyloarthritis (AS) or digital osteoarthritis (DA) practices and beliefs about influence of food and diet on their rheumatic disease.

200 patients of each disease will be included in this cross-sectional non interventional study Factors associated with specific practices or specific beliefs will be determined.

Only questionnaires are used in this study.

• Study Type: Observational
• Enrollment (Actual): 448

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Service de Rhumatologie - Hôpital Saint Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

RA (EULAR/ACR criteria) AS (ASAS criteria ) DA (ACR criteria)

Description

Inclusion Criteria:

• Over 18 years of age
• Rheumatoid arthritis (RA) according to ACR/EULAR criteria or axial spondyloarthritis (AS) according to ASAS 2009 criteria or digital osteoarthritis (DA) according to ACR criteria.

Exclusion Criteria:

• Severe upper functional or psychiatric disorders
• Patients under guardianship or trusteeship
• Patients unable to answer the questionnaire in French

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Rheumatoid arthritis; EULAR-ACR criteria Whatever the treatment and the disease activity
Axial spondyloarthritis; ASAS criteria for axial disease Whatever the treatment and the disease activity
digital osteoarthritis; According to ACR criteria Whatever the treatment and the disease activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who follow or have followed at least one diet for their rheumatic disease among gluten-free, cow's milk, lactose-free, vegetarian, vegan, Seignalet, Mediterranean, fasting period	Binary criterion: Diet follower Yes/No	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison between each rheumatism rheumatoid arthritis, Axial spondyloarthritis digital osteoarthritis of the prevalence of patients having followed or following one or more diets	Proportion of diet follower patients in RA versus AS versus DA. Specific food and diet questionnaires will be used in this study.	10 minutes
For each type of food, prevalence of patients with RA considering that the food influences the rheumatic pain in each rheumatic disease	for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with RA considering that food influence their disease symptoms	10 minutes
For each type of food, prevalence of patients with AS considering that the food influences the rheumatic pain in each rheumatic disease	for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with AS considering that food influence their disease symptoms	10 minutes
For each type of food, prevalence of patients with DA considering that the food influences the rheumatic pain in each rheumatic disease	for each type of food (meat, vegetables, fruits, grains, nuts, fish, alcohol, soda), prevalence of patients with DA considering that food influence their disease symptoms	10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in RA.	In RA population:Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.; Sociodemorgraphic parameters:Age, gender, education level.; Physiologic parameters: Autoantibody status, BMI; Clinical parameters: treatments, disease activity using DAS 28 scale.	10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in AS.	In AS population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.; Sociodemorgraphic parameters:Age, gender, education level.; Physiologic parameters: BMI; Clinical parameters: treatments, disease activity using BASDAI Scale	10 minutes
Research of socio-demographic or rheumatic factors associated with dieting in DA.	In DA population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.; Sociodemorgraphic parameters: Age, gender, education level.; Physiologic parameters: BMI; Clinical parameters: treatments, disease activity using 0-100mm visual analogic scale	10 minutes

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jérémie SELLAM, Prof,MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): April 18, 2019
• Study Completion (Actual): April 18, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; diet; hand osteoarthritis; Axial spondyloarthritis; beliefs
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Rheumatic Diseases; Spondylitis; Spondylarthritis
• Other Study ID Numbers: NI18027J; 2018-A01340-55 (Other Identifier: ANSM); HAO18041 (Other Grant/Funding Number: Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No