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 4 and