A culturally adapted online Mediterranean diet intervention for metabolic dysfunction-associated steatotic liver disease (TIMA): study protocol for a randomized controlled trial

BACKGROUND: The Mediterranean diet (MedDiet) is widely recognized for its beneficial effects on hepatic steatosis. However, optimal strategies to support dietary adherence among patients with metabolic dysfunction-associated steatotic liver disease (MASLD), particularly in non-Mediterranean regions where the MedDiet is not habitual, remain underexplored. OBJECTIVE: To evaluate the effectiveness of a culturally adapted MedDiet for MASLD through the implementation of real-time video counseling combined with behavior change techniques (BCTs). METHODS: This is a 12-week, single-center, two-arm, parallel-group randomized controlled trial registered at ClinicalTrials.gov (identifier: NCT06503120). Adults who fulfill the clinical diagnosis of MASLD and have ≥ 5% hepatic fat content on MRI-PDFF will be randomly assigned to receive either an isocaloric culturally adapted MedDiet intervention or standard care. The intervention comprises two components. First, participants will receive four structured real-time video counseling sessions (15-20 min each) at weeks 0, 3, 6, and 9. These sessions will be delivered by a registered dietitian via an online platform, guided by each participant's 3-day photographic food diary and a Taiwanese version Mediterranean Diet Adherence Screener scores to provide personalized dietary advice. Second, participants will receive weekly text messages underpinned by BCTs to address individual dietary gaps and reinforce adherence. The primary outcome is the relative change in intrahepatic fat content, assessed by MRI-PDFF at week 12. Secondary outcomes include the changes in liver enzymes, lipid profile, liver stiffness, serum metabolites, gut microbiota composition, dietary adherence, quality of life, and anthropometric measures. DISCUSSION: This is the first randomized controlled trial to evaluate a fully remote, dietitian-led culturally adapted MedDiet intervention using real-time video counseling and text-based BCTs in patients with MASLD. This approach may support scalable, patient-centered dietary strategies for improving liver and metabolic health in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT06503120. Registered on July 9, 2024.