Abstract
BACKGROUND: Increased appetite and weight gain are common adverse effects of glucocorticoid therapy in patients with systemic lupus erythematosus (SLE). Concerns about appearance-related changes due to weight gain can reduce medication adherence. Moreover, the complex interplay among glucocorticoids, mood changes, sleep disturbances, and appetite can influence eating behaviors. Daily data collection using ecological momentary assessment and analysis of interrelations may help clarify these dynamics. Furthermore, real-time feedback based on daily eating behavior may help patients regulate appetite and eating patterns. Accordingly, we developed Mogu!☆Log, a smartphone-based app that enables daily self-reporting of eating behaviors, appetite, and mood and provides graphical feedback on meal frequency and perceived control over eating. OBJECTIVE: This paper presents a protocol for a pilot randomized controlled trial designed to evaluate the effects of real-time feedback on eating behaviors using the Mogu!☆Log app among patients with newly diagnosed SLE who had started glucocorticoid therapy. METHODS: This multicenter study recruited Japanese patients with newly diagnosed SLE who had started glucocorticoid therapy across 15 hospitals with rheumatology services. Participants were randomly assigned in a 1:1 ratio to two groups: (1) the immediate feedback group, which receives graphical feedback on meal frequency and perceived control over eating starting from day 1, and (2) the delayed feedback group, which uses the same app without feedback for the first 14 days and begins receiving identical feedback from day 15. Participants enter data daily from day 1 to day 21 after randomization. The primary outcome is the mean number of meals on day 14 after glucocorticoid initiation. Secondary outcomes include the loss-of-control-over-eating score and a 5-item visual analog scale-based appetite score, both recorded on day 14. Between-group mean differences will be analyzed using 2-tailed t tests. The target sample size is 60. In an embedded observational "study within a trial," linear mixed models will examine whether glucocorticoid dose influences appetite scores through mood and sleep changes. RESULTS: We hypothesized that participants receiving immediate feedback will have fewer meals on day 14, reduced loss of control over eating, and better appetite scores. The study received funding in April 2019, April 2022, and April 2024. Recruitment began in October 2024, and 17 participants had been enrolled as of May 2025. Data collection is expected to be completed by March 2027; data analysis has yet to begin. Results will be submitted for publication and reported to the University Hospital Medical Information Network (UMIN) registry in the summer of 2027. CONCLUSIONS: This pilot trial will provide foundational data on the feasibility and efficacy of smartphone-based real-time feedback in managing glucocorticoid-induced appetite increase in patients with SLE. These findings may contribute to the growing body of literature on app-based interventions for medication-related adverse effects.