JMIR Publications

ABSTRACT

Background:

Chronic liver disease (CLD) is a major public health burden, particularly among middle-aged men with metabolic risk factors such as obesity and type 2 diabetes. Although sustained lifestyle modification is critical for preventing disease progression, long-term self-management in this population is often suboptimal. Mobile health interventions show promise for supporting self-management; however, most are patient-centered and rarely incorporate structured family engagement despite evidence highlighting the importance of social support.

Objective:

This study aims to develop and formalize a protocol for a family-supported digital health coaching intervention for middle-aged men with CLD and metabolic risk factors and to evaluate its feasibility and acceptability prior to effectiveness testing.

Methods:

This parallel-group randomized controlled trial, approved by the Institutional Review Board of Y University Health System (Approval No. 4-2025-0117) and sponsored by Y University Health System, will be conducted in Seoul, Republic of Korea. Eligible participants are men aged 40–64 years with CLD for ≥6 months and at least one metabolic risk factor; key exclusions include decompensated cirrhosis and active malignancy within 5 years. A total of 82 patient–family dyads (164 participants) will be randomized (1:1) to either a 12-week smartphone-based intervention grounded in the Information–Motivation–Behavioral Skills model or usual care. The primary outcome is change in Nonalcoholic Fatty Liver Disease Self-Management Questionnaire score from baseline to 12 weeks. Secondary outcomes include perceived social support (MSPSS), depressive symptoms (PHQ-9), family experience (FIES:CI), sleep quality (PSQI-K), and clinical indicators derived from electronic medical records, including body mass index, waist circumference, aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, triglycerides, high-density lipoprotein cholesterol, and glycated hemoglobin as applicable. Data will be analyzed using repeated-measures analysis to evaluate group-by-time effects under an intention-to-treat framework.

Results:

Expert content validation demonstrated excellent validity (Content Validity Index = 1.00). Usability testing indicated high acceptability (System Usability Scale mean 86.88, standard deviation 7.58). The finalized protocol operationalizes information, motivation, and behavioral skills within a structured digital platform incorporating dyadic family involvement. Enrollment began in May 2025 and is expected to be completed by March 2026.

Conclusions:

This protocol describes the development of a family-supported digital intervention for CLD management and provides a framework for evaluating family-centered self-management strategies in middle-aged men with metabolic risk factors. Clinical Trial: Clinical Research Information Service (KCT0010494), registered on March 25, 2025. Secondary identifiers: none. Individual participant data will be available upon reasonable request following publication.