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Completed

NCT Number: NCT03770884

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

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

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Key information

Conditions

Rheumatoid Arthritis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Hand Osteoarthritis Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Rhumatologie - Hôpital Saint Antoine

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 10 minutes

    Binary criterion: Diet follower Yes/No

Secondary outcomes

  1. comparison between each rheumatism rheumatoid arthritis, Axial spondyloarthritis digital osteoarthritis of the prevalence of patients having followed or following one or more diets

    Time frame: 10 minutes

    Proportion of diet follower patients in RA versus AS versus DA. Specific food and diet questionnaires will be used in this study.

  2. For each type of food, prevalence of patients with RA considering that the food influences the rheumatic pain in each rheumatic disease

    Time frame: 10 minutes

    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

  3. For each type of food, prevalence of patients with AS considering that the food influences the rheumatic pain in each rheumatic disease

    Time frame: 10 minutes

    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

  4. For each type of food, prevalence of patients with DA considering that the food influences the rheumatic pain in each rheumatic disease

    Time frame: 10 minutes

    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

  5. Research of socio-demographic or rheumatic factors associated with dieting in RA.

    Time frame: 10 minutes

    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.

  6. Research of socio-demographic or rheumatic factors associated with dieting in AS.

    Time frame: 10 minutes

    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

  7. Research of socio-demographic or rheumatic factors associated with dieting in DA.

    Time frame: 10 minutes

    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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: RHUMADIET

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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