Patients and study design
NAFLD, NASH, steatohepatitis
STEATOHEPATITIS
This trial was a 16-week single-center, randomized controlled pilot study (NCT04872777) designed to enroll 40 adult patients with NASH and a smartphone. The study was conducted at Penn State Milton S. Hershey Medical Center and the Penn State College of Medicine in the US. NASH was defined by either (1) a historical liver biopsy with evidence of steatohepatitis [NAFLD Activity Score (NAS) Patients were randomized 1:1 to intervention with NW, an mHealth-delivered comprehensive lifestyle intervention program that combines smartphone application self-management with human coaching to create and sustain lasting behavioral change (Figure S1, This study was conducted according to the guidelines of the Declaration of Helsinki, Good Clinical Practice guidelines, and local regulatory requirements and was approved by the Penn State College of Medicine Institutional Review Board (No. 17544). It was designed and conducted by the principal investigator in collaboration with the study sub-investigators. Formal written consent was obtained from each participant. The principal investigator collected the data and monitored the conduct of the study. All authors had access to the data, participated in the data interpretation, and can vouch for the accuracy and completeness of the data as well as the fidelity of the trial to the protocol. The final manuscript was reviewed and approved by all authors.