JMIR Publications

ABSTRACT

Background:

Increased appetite and weight gain are the common adverse effects of glucocorticoid (GC) therapy in patients with systemic lupus erythematosus (SLE). Concerns regarding appearance-related changes from weight gain can significantly affect medication adherence. Additionally, the complex interplay among GCs, mood changes, sleep disturbances, and appetite may influence eating behaviors. Daily data collection using an ecological momentary assessment (EMA) and analysis of interrelations are crucial to better understand these dynamics in SLE. Furthermore, real-time feedback interventions based on daily eating behavior data may help patients regulate their appetite and eating patterns. Accordingly, we developed “Mogu!☆Log,” a smartphone-based application that monitors eating behaviors, appetite, and mood and provides graphical feedback on meal frequency and perceived control over eating.

Objective:

This study presents a protocol for a pilot randomized controlled trial to evaluate the effects of real-time feedback on eating behaviors via a smartphone application among patients with newly diagnosed SLE started with GC therapy

Methods:

This study recruited Japanese patients with newly diagnosed SLE started with GC therapy at 15 hospitals with rheumatology services. Participants were randomly classified in two groups in a 1:1 ratio: (1) immediate feedback and (2) delayed feedback, starting on day 14. The primary outcome is the mean number of meals consumed on day 14 after GC initiation. Secondary outcomes include loss of control over eating and scores on the five-item Visual Analog Scale-based Appetite Scale on day 14. Participants input daily data for 21 days. Between-group mean differences will be analyzed using t-tests. The target sample size is 60 participants. Additionally, an observational Study Within A Trial (SWAT) will employ linear mixed models to evaluate whether the GC dose influences appetite scores through changes in mood, thoughts, and sleep metrics.

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 as of May 2025, 17 participants were enrolled. Data collection is expected to be completed by March 2027, with data analysis yet to begin. Results will be submitted for publication and reported to the UMIN registry in summer 2027.

Conclusions:

This pilot trial will provide foundational data on the efficacy of smartphone-based real-time feedback in managing GC-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. Clinical Trial: UMIN Clinical Trials Registry UMIN000052113 https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000059479