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

Rheumatoid Arthritis Clinical Trial

— RHUMADIET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770884
• Other study ID #: NI18027J
• Secondary ID: 2018-A01340-55HA
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: April 18, 2019

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Hand Osteoarthritis
• Osteoarthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Spondylarthritis

Locations

Country	Name	City	State
France	Service de Rhumatologie - Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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