Effects of a Telehealth-Delivered Mediterranean Diet Intervention in Adults with Rheumatoid Arthritis (MEDRA): A Randomised Controlled Trial

Objective To compare the effects a Mediterranean diet (MedDiet) versus the Irish Healthy Eating Guidelines (HEG) on physical function and quality of life in adults with rheumatoid arthritis (RA) in Ireland. Methods Forty-four adults with RA were randomised (1:1) to the MedDiet or HEG for 12 weeks. The intervention included three video teleconsultations and two follow-up telephone calls facilitated by a Registered Dietitian (RD). Changes in physical function by Health Assessment Questionnaire-Disability Index (HAQ-DI) and quality of life by Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) were the primary outcomes measured. Secondary outcomes included changes in dietary adherence, physical activity by Yale Physical Activity survey (YPAS), patient-perceived pain and general health, and anthropometric measures. All measurements were administered at baseline and repeated at 6 and 12 weeks. Results Forty participants completed the study. Participants were primarily females (87.5%), mean age was 47.5 ± 10.9 years. At the end of the intervention, participants in the MedDiet group reported significantly better physical function (p=0.006) and quality of life (p=0.037) compared to HEG group. From baseline to 12 weeks, physical function significantly improved in both die tgroups, MedDiet (0.9 ± 0.5 to 0.5 ± 0.4 units, p <0.001) and HEG (1.4 ± 0.7 to 1.0 ± 0.6 units, p<0.001). Quality of life also significantly improved in the MedDiet (10.1 ±7.5 to 4.0 ± 4.7 units, p<0.001) and HEG group (11.25 ±7.2 to 7.9 ±6.4 units, p=0.048). Physical activity improved significantly in the MedDiet (56.7 ±28.6 to 70.6±33.5 points, p=0.01) but not within the HEG group despite similar recommendations. Conclusion Adhering to the MedDiet and Irish Healthy Eating Guidelines resulted in improvements in RA patient-reported outcomes. The changes observed in both diet groups are likely due to the improvement in overall diet quality irrespective of dietary prescription. Trial registration number NCT04262505 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04262505 ### Funding Statement This study was funded by the School of Allied Health postgraduate scholarship ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: All procedures involving patients were approved by the Education and Health Sciences Research Ethics Committee at the University of Limerick (2020\_09\_05_EHS) and by the Health Service Executive Mid-Western Regional Hospital Research Ethics Committee (REC Ref 103/19). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors