<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770884</url>
  </required_header>
  <id_info>
    <org_study_id>NI18027J</org_study_id>
    <secondary_id>2018-A01340-55</secondary_id>
    <secondary_id>HAO18041</secondary_id>
    <nct_id>NCT03770884</nct_id>
  </id_info>
  <brief_title>Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)</brief_title>
  <acronym>RHUMADIET</acronym>
  <official_title>Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital&#xD;
      arthritis)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate in patients having rheumatoid arthritis (RA), or axial spondyloarthritis (AS)&#xD;
      or digital osteoarthritis (DA) practices and beliefs about influence of food and diet on&#xD;
      their rheumatic disease.&#xD;
&#xD;
      200 patients of each disease will be included in this cross-sectional non interventional&#xD;
      study Factors associated with specific practices or specific beliefs will be determined.&#xD;
&#xD;
      Only questionnaires are used in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">April 18, 2019</completion_date>
  <primary_completion_date type="Actual">April 18, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>10 minutes</time_frame>
    <description>Binary criterion: Diet follower Yes/No</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparison between each rheumatism rheumatoid arthritis, Axial spondyloarthritis digital osteoarthritis of the prevalence of patients having followed or following one or more diets</measure>
    <time_frame>10 minutes</time_frame>
    <description>Proportion of diet follower patients in RA versus AS versus DA. Specific food and diet questionnaires will be used in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For each type of food, prevalence of patients with RA considering that the food influences the rheumatic pain in each rheumatic disease</measure>
    <time_frame>10 minutes</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For each type of food, prevalence of patients with AS considering that the food influences the rheumatic pain in each rheumatic disease</measure>
    <time_frame>10 minutes</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For each type of food, prevalence of patients with DA considering that the food influences the rheumatic pain in each rheumatic disease</measure>
    <time_frame>10 minutes</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Research of socio-demographic or rheumatic factors associated with dieting in RA.</measure>
    <time_frame>10 minutes</time_frame>
    <description>In RA population:Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.&#xD;
Sociodemorgraphic parameters:Age, gender, education level.&#xD;
Physiologic parameters: Autoantibody status, BMI&#xD;
Clinical parameters: treatments, disease activity using DAS 28 scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Research of socio-demographic or rheumatic factors associated with dieting in AS.</measure>
    <time_frame>10 minutes</time_frame>
    <description>In AS population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.&#xD;
Sociodemorgraphic parameters:Age, gender, education level.&#xD;
Physiologic parameters: BMI&#xD;
Clinical parameters: treatments, disease activity using BASDAI Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Research of socio-demographic or rheumatic factors associated with dieting in DA.</measure>
    <time_frame>10 minutes</time_frame>
    <description>In DA population: Unajusted and adjusted risk of diet (odds ratio) assiociated with the following factors reported from patient file or patient questionnaires.&#xD;
Sociodemorgraphic parameters: Age, gender, education level.&#xD;
Physiologic parameters: BMI&#xD;
Clinical parameters: treatments, disease activity using 0-100mm visual analogic scale</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">448</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Axial Spondyloarthritis</condition>
  <condition>Hand Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis</arm_group_label>
    <description>EULAR-ACR criteria Whatever the treatment and the disease activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Axial spondyloarthritis</arm_group_label>
    <description>ASAS criteria for axial disease Whatever the treatment and the disease activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>digital osteoarthritis</arm_group_label>
    <description>According to ACR criteria Whatever the treatment and the disease activity</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        RA (EULAR/ACR criteria) AS (ASAS criteria ) DA (ACR criteria)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Rheumatoid arthritis (RA) according to ACR/EULAR criteria or axial spondyloarthritis&#xD;
             (AS) according to ASAS 2009 criteria or digital osteoarthritis (DA) according to ACR&#xD;
             criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe upper functional or psychiatric disorders&#xD;
&#xD;
          -  Patients under guardianship or trusteeship&#xD;
&#xD;
          -  Patients unable to answer the questionnaire in French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jérémie SELLAM, Prof,MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Rhumatologie - Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rheumatoid arthritis</keyword>
  <keyword>Axial spondyloarthritis</keyword>
  <keyword>hand osteoarthritis</keyword>
  <keyword>diet</keyword>
  <keyword>beliefs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Axial Spondyloarthritis</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770884
org study id: NI18027J
secondary id: 2018-A01340-55
secondary id: HAO18041
nct id: NCT03770884
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital
      arthritis)
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: Binary criterion: Diet follower Yes/No
measure: 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
description: Proportion of diet follower patients in RA versus AS versus DA. Specific food and diet questionnaires will be used in this study.
measure: 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
description: 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
measure: 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
description: 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
measure: 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
description: 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
measure: Research of socio-demographic or rheumatic factors associated with dieting in RA.
time frame: 10 minutes
description: 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.
measure: Research of socio-demographic or rheumatic factors associated with dieting in AS.
time frame: 10 minutes
description: 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
measure: Research of socio-demographic or rheumatic factors associated with dieting in DA.
time frame: 10 minutes
description: 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
arm group label: Rheumatoid arthritis
description: EULAR-ACR criteria Whatever the treatment and the disease activity
arm group label: Axial spondyloarthritis
description: ASAS criteria for axial disease Whatever the treatment and the disease activity
arm group label: digital osteoarthritis
description: According to ACR criteria Whatever the treatment and the disease activity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jérémie SELLAM, Prof,MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Arthritis, Rheumatoid
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
mesh term: Rheumatic Diseases
sharing ipd: No