Family-Supported mHealth Coaching for Middle-Aged Men With Chronic Liver Disease and Metabolic Risk Factors: Protocol for a Pilot Randomized Controlled Trial

Chronic liver disease (CLD) remains a substantial public health burden, particularly among middle-aged men with metabolic risk factors. Sustained lifestyle modification is essential for preventing disease progression, but long-term self-management in this population is often suboptimal. Although mobile health (mHealth) interventions may support self-management, most are patient-centered and rarely incorporate structured family participation.

This study aims to develop a family-supported mHealth coaching intervention for middle-aged men with CLD and metabolic risk factors, evaluate the feasibility of the intervention and trial procedures, and explore preliminary app usability and changes in patient- and family-related outcomes through a pilot randomized controlled trial (RCT).

This 2-arm, parallel-group pilot RCT was conducted at the Liver Center of Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea. Eligible patients were male outpatients aged 40 to 64 years who had CLD for at least 6 months and at least 1 metabolic risk factor. The planned sample size was 82 patients, with 41 patients per group. Enrolled patients were randomly assigned in a 1:1 ratio to a 12-week family-supported mHealth coaching intervention or usual outpatient care plus a standardized educational video delivered via text message. Guided by the information-motivation-behavioral skills (IMB) model, the intervention integrates app-based self-monitoring, individualized feedback, online coaching, and opportunities for family participation. The feasibility and acceptability of the intervention and trial procedures will be evaluated. Primary outcomes are self-management behavior, perceived social support, depressive symptoms, and sleep quality; secondary outcomes include physical and clinical indicators and family experiences. Outcomes were assessed at baseline (week 0) and postintervention (week 12). Between-group changes will be examined using appropriate parametric or nonparametric tests, with an analysis of covariance used for baseline-adjusted comparisons. Effect estimates will be reported with 95% CIs and interpreted as preliminary. Complete-case analyses will be conducted without imputation of missing data.

This study was funded in March 2023 and received institutional review board approval on April 9, 2025 (approval 4-2025-0117). The first participant was enrolled in May 2025, and data collection was completed in March 2026. A total of 52 patient participants were enrolled and randomized, of whom 35 completed the 12-week follow-up, corresponding to an overall attrition rate of 32.7%. Data analysis and preparation of the main trial manuscript are currently underway, with submission for publication anticipated in winter 2026.

This pilot RCT evaluates an IMB model-informed, family-supported mHealth coaching intervention integrating app-based self-monitoring and individualized coaching. The findings will provide preliminary evidence regarding feasibility, acceptability, and changes in patient- and family-related outcomes and will inform intervention refinement and the design of a future definitive RCT.

Clinical Research Information Service KCT0010494; https://tinyurl.com/75m6c7c6.

DERR1-10.2196/95490.