HEalthy Living in Inflammatory Arthritis (HELIA trial): a study protocol for a randomized controlled trial comparing the effectiveness between an online, interactive lifestyle intervention program and general nutrition recommendations. (Preprint)

<sec> <title>BACKGROUND</title> Innovative disease management strategies have significantly improved clinical outcomes in inflammatory arthritis (IA). Nowadays, more than 80% of IA patients achieve low disease activity (LDA). Unfortunately, despite achieving LDA, the disease still continues to exert a considerable impact on patients’ lives, manifested as persistent fatigue, pain and morning stiffness, collectively referred to as residual disease activity. Despite this residual disease activity, IA patients often express a desire to taper their medication, even at the risk of a disease flare. For these patients, a lifestyle intervention program may add value by reducing inflammatory activity, potentially alleviating the disease burden and the risk of a flare. </sec> <sec> <title>OBJECTIVE</title> This study aims to compare the effectiveness of an online, interactive lifestyle intervention program (Leef! met Reuma) with general nutrition recommendations offered as part of usual care in rheumatoid arthritis and psoriatic arthritis patients with a LDA from a clinical, societal and patients’ point of view. </sec> <sec> <title>METHODS</title> The HELIA trial is an open-label, randomized controlled clinical trial comparing the effectiveness of a lifestyle intervention with general nutrition recommendations. The lifestyle intervention program consists of a 6-month intensive part, followed by an 18-month aftercare period. The program focusses on 4 pillars, namely nutrition, exercise, relaxation and sleep. The prescribed diet is comparable to the Mediterranean diet, with an emphasis on unprocessed foods (especially vegetables). The general nutrition recommendations are based on the Dutch food-based dietary guidelines and are given by the research nurse. Ethical approval was obtained from the Ethics Committee of the Erasmus Medical Centre (MEC-2022-0448). The trial is registered in the ISRCTN registry and the protocol follows SPIRIT guidelines. </sec> <sec> <title>RESULTS</title> The primary outcome is the proportional difference in Disease Activity Score (DAS28)/Disease Activity in Psoriatic Arthritis (DAPSA) remission and/or those who were able to taper their medication without experiencing a disease flare after 12 months of follow-up. Additionally, a cost-effectiveness analysis will be conducted using the incremental cost-effectiveness ratio as outcome. Other secondary endpoints include health risk and clinical and patient-reported outcomes over time and at specific timepoints. Primary and secondary outcomes are analysed according to an intention-to-treat (ITT) principle. The results of the HELIA trial will be submitted for publication in peer-reviewed journals. </sec> <sec> <title>CONCLUSIONS</title> A randomized controlled trial is performed to compare the effectiveness of an online, interactive lifestyle intervention program and general nutrition recommendations in IA patients with LDA from a clinical, patient and societal point of view. If the intervention is proven effective, than it can be applied as a complementary option to current treatment approaches. </sec> <sec> <title>CLINICALTRIAL</title> ISRCTN registry ISRCTN2129028; https://www.isrctn.com/search?q=21290281 </sec>