Effect of an Online, Interactive Lifestyle Intervention Program on 12-Month Disease Management Outcomes: Protocol for The Healthy Living in Inflammatory Arthritis (HELIA) Randomized Controlled Trial.

Background: Innovative disease management strategies have significantly improved clinical outcomes in inflammatory arthritis (IA). Although more than 80% of patients achieve low disease activity (LDA), the disease continues to exert a considerable impact on patients' lives. For these patients with IA, a lifestyle intervention program may add value by reducing inflammatory activity, potentially alleviating the disease burden and the risk of a flare. Objective: This study aimed to compare 12-month disease management outcomes between patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) with LDA who follow an online, interactive lifestyle intervention program (Leef! met Reuma) and those who receive general nutrition recommendations offered as part of usual care. Methods: The Healthy Living in Inflammatory Arthritis (HELIA) trial is an open-label, randomized controlled clinical trial with the aim of enrolling 200 adult patients diagnosed with RA or PsA according to the American College of Rheumatology or European Alliance of Associations for Rheumatology 2010 criteria, or Classification for Psoriatic Arthritis criteria, respectively. Other inclusion criteria were (1) having LDA defined as Disease Activity Score ≥2.6 and <3.5 or Disease Activity in Psoriatic Arthritis >4 and <16 and (2) stable disease-modifying antirheumatic drug dosages for ≥6 months prior to randomization. Patients are randomized into a lifestyle intervention or general nutrition recommendations using a 1:1 allocation ratio. The lifestyle intervention program consists of a 6-month intensive part, followed by an 18-month aftercare period. During the intensive part, there were 5 online Zoom (Zoom Communications Inc) meetings and 7 coaching sessions. The program focuses on 4 pillars, namely nutrition, exercise, relaxation, and sleep. The prescribed diet resembles the Mediterranean diet, with an emphasis on unprocessed foods. The general nutrition recommendations are based on the Dutch food-based dietary guidelines. The primary objective is the proportional difference in Disease Activity Score and Disease Activity in Psoriatic Arthritis remission and/or successful tapering of disease-modifying antirheumatic drug treatment after 12 months of follow-up. Meeting either criterion is sufficient to qualify for the primary outcome. Additionally, a cost-effectiveness analysis will be conducted using the incremental cost-effectiveness ratio as the outcome. Other secondary objectives include health risk and clinical and patient-reported outcomes over time and at specific time points. Primary and secondary outcomes are analyzed according to an intention-to-treat principle. Results: The trial was registered in the ISRCTN (International Standard Randomised Controlled Trial Number) registry retrospectively after recruitment had begun, due to administrative issues. The authors acknowledge this deviation. Conclusions: A randomized controlled trial is performed to compare the effectiveness of an online, interactive lifestyle intervention program and general nutrition recommendations in patients with IA with LDA from a clinical, patient, and societal point of view. If the intervention is proven effective, it can be applied as a complementary option to current treatment approaches.