ArticleJMIR research protocols2026
Effectiveness and Feasibility of Self-Monitoring for Weight Management in Individuals With Mental Disorders Using Digital Intervention: Protocol for a Stepped-Wedge Cluster Randomized Trial ("SWIM" Study).
Article in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
Background: Individuals with schizophrenia or bipolar disorder face a significantly elevated risk of obesity, primarily due to weight gain associated with psychiatric medications and lifestyle factors. While digital self-monitoring tools offer scalable solutions, their application remains underexplored in psychiatric populations. To address these gaps, this type 1 hybrid effectiveness-implementation study investigates the preliminary effectiveness and implementation feasibility of a mobile health-assisted weight management intervention for patients with severe mental illness. Objective: This study aims to evaluate the preliminary effectiveness and implementation feasibility of a mobile health-assisted weight management intervention for patients with severe mental illness transitioning from inpatient care to community-based recovery. Methods: This single-center, open-cohort stepped-wedge cluster randomized trial with a 2-month step duration will recruit 204 patients from 6 clinical units. Clusters are randomized into 2 waves, with staggered transitions to a digital intervention, including smart scales, health apps, and biweekly educational modules, over a 6-month observation period. The design evaluates the intervention across the transition from inpatient care to community-based recovery. The primary outcome is the proportion of participants achieving ≥5% weight loss at month 6. Implementation feasibility is assessed through device technical success and intervention adherence (defined as ≥50% completion of weekly weigh-ins and daily dietary logs). Results: Participant data collection began in May 2023 and was completed by June 2025 with a total of 204 participants. The publication of key findings and results is anticipated in late 2026. Conclusions: This protocol describes a pragmatic, technology-supported intervention designed to address metabolic side effects in a tertiary psychiatric setting. By bridging the gap between acute hospitalization and community recovery, this hybrid stepped-wedge cluster randomized trial provides a crucial framework for integrating digital metabolic monitoring into routine clinical workflows for vulnerable populations.
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