JMIR Publications

ABSTRACT

Background:

Individuals with schizophrenia or bipolar disorder have a significantly elevated risk of obesity, largely due to antipsychotic medications and lifestyle factors. Digital self-monitoring tools may offer scalable solutions but remain underexplored in psychiatric populations.

Objective:

This study aims to evaluate the effectiveness and feasibility of a mobile health-assisted weight management intervention for patients with severe mental illness.

Methods:

This single-center, batched stepped-wedge cluster randomized trial will recruit 204 patients from six psychiatric units. Clusters are randomized into two waves, transitioning to a digital health intervention—including smart scales, health apps, dietary logging, and behavioral nudges—during Months 3–6. All clusters serve as controls pre-intervention. Outcomes include weight loss, metabolic and clinical symptoms and functional changes, adherence and usability of the digital intervention.

Results:

We anticipate that ≥50% of participants in the first batch will achieve ≥5% weight loss at 6 months. Improvements are also expected in BMI, body composition, blood glucose, lipid levels, and self-reported functioning and quality of life. Greater adherence to digital self-monitoring is hypothesized to correlate with better outcomes across all measures.

Conclusions:

This protocol describes a pragmatic, technology-supported intervention to address antipsychotic-induced obesity. Findings may inform scalable digital strategies to improve physical health in psychiatric populations. Clinical Trial: ClinicalTrials.gov NCT05866107. Registered on Aug 29, 2023.