protocolSection identificationModule nctId: NCT06305936, orgStudyIdInfo id: PLATE H-23042292, briefTitle: Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis, acronym: PLATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bispebjerg Hospital, class: OTHER, collaborators name: Glostrup University Hospital, Copenhagen, descriptionModule briefSummary: In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention.Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised feasibility study of an intervention group, receiving 100% plant-based diet and a control group, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Not possible to blind participants and study staff delivering the intervention to allocation status, whereas all outcome data is planned to be collected by blinded outcome assessors., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Intervention with 100% plant-based diet, outcomesModule primaryOutcomes measure: Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires, primaryOutcomes measure: Evaluation of Study Acceptance, primaryOutcomes measure: Recruitment, primaryOutcomes measure: Retention, primaryOutcomes measure: Intervention adherence, secondaryOutcomes measure: Disease Activity Score (DAS28), secondaryOutcomes measure: Fatigue: Bristol Rheumatoid Arthritis Fatigue (BRAF MDQ), secondaryOutcomes measure: Pain (VAS), secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Anxiety/depression, secondaryOutcomes measure: Physical function, secondaryOutcomes measure: Impact of rheumatoid arthritis (RA), secondaryOutcomes measure: The EuroQuality of Life (EQ-5D), secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Waist- and hip circumference, secondaryOutcomes measure: Disease activity, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Quantification of tender and swollen joints, secondaryOutcomes measure: C-reactive Protein (CRP), secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Leukocytes, secondaryOutcomes measure: Thrombocytes, secondaryOutcomes measure: Hemoglobin (HbA1c), secondaryOutcomes measure: D-vitamin, secondaryOutcomes measure: Low-density lipoprotein (LDL), secondaryOutcomes measure: High-density lipoprotein (HDL), secondaryOutcomes measure: Triglyceride, secondaryOutcomes measure: Total cholesterol, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Clinical Research and Prevention, BispebjergH, status: ACTIVE_NOT_RECRUITING, city: Frederiksberg, zip: DK 2000, country: Denmark, geoPoint lat: 55.67938, lon: 12.53463, locations facility: The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup, status: RECRUITING, city: Glostrup, zip: 2600, country: Denmark, contacts name: Tanja Thomsen, Ph.D., role: CONTACT, phone: +4538163107, email: tanja.thomsen@regionh.dkdkTanja.thomsen@regionh.dk, contacts name: Kamille Torp, Ph.D., role: CONTACT, phone: +4538163113, email: kamille.almer.bernsdorf.torp@regionh.dk, contacts name: Bente Appel Esbensen, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 55.6666, lon: 12.40377, hasResults: False