Mobile health lifestyle intervention program leads to clinically significant loss of body weight in patients with NASH

Abstract

Background & Aims: Lifestyle intervention remains the foundation of clinical care for patients with NASH; however, most patients are unsuccessful in enacting sustained behavioral change. There remains a clear unmet need to develop lifestyle intervention programs to support weight loss. Mobile health (mHealth) programs offer promise to address this need, yet their efficacy remains unexplored. Approach & Results: We conducted a 16-week randomized controlled clinical trial involving adults with NASH. Patients were randomly assigned (1:1 ratio) to receive Noom Weight (NW), a mHealth lifestyle intervention program, or standard clinical care. The primary end point was a change in body weight. Secondary end points included feasibility (weekly app engagement), acceptability (>50% approached enrolled), and safety. Of 51 patients approached, 40 (78%) were randomly assigned (20 NW and 20 standard clinical care). NW significantly decreased body weight when compared to standard clinical care (-5.5 kg vs. -0.3 kg, p = 0.008; -5.4% vs. -0.4%, p = 0.004). More NW subjects achieved a clinically significant weight loss of ≥5% body weight (45% vs. 15%, p = 0.038). No adverse events occurred, and the majority (70%) of subjects in the NW arm met the feasibility criteria. Conclusions: This clinical trial demonstrated that NW is not only feasible, acceptable, and safe but also highly efficacious because this mHealth lifestyle intervention program led to significantly greater body weight loss than standard clinical care. Future large-scale studies are required to validate these findings with more representative samples and to determine if mHealth lifestyle intervention programs can lead to sustained, long-term weight loss in patients with NASH.

Telemedicine in Patients Affected by Chronic Liver Disease: A Scoping Review of Clinical Outcomes and the Devices Evaluated

“…Additionally, Duarte-Rojo et al [34] tested a smartphone application (EL-FIT, Exercise and Liver FITness) on inpatients with end-stage liver disease. Through interaction with all app features (videos, perceived exertion, and gamification/motivational features), the patients improved their physical performance by 35%, and similar results were described by Stine et al [35].…”

Telemedicine as an Option for Monitoring Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Patients Facing the COVID-19 Pandemic: A Systematic Review and Meta-Analysis

“…The characteristics of the included studies were presented in Table 1 , supplemented with additional information. Predominantly, the studies were conducted in the USA [ 26 , 29 , 30 ], followed by Portugal [ 27 ] and Singapore [ 31 ]. Three out of the five studies, namely Lim et al, Policarpo et al, and Stine et al, were randomized controlled trials (RCTs) conducted at a single center within outpatient hospital and clinic settings.…”

“…Out of the five included studies, three were included in the meta-analysis, while two studies were conducted with single-arm designs. Three studies (Lim et al, Policarpo et al, Stine et al) reported outcomes regarding BW and BMI [ 26 , 31 ]. However, one study (Policarpo et al) did not provide the standard deviation outcomes for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) [ 27 ].…”

The rise of mobile apps for the management of chronic liver disease

“…Stine et al 5 conducted a 16-week randomized controlled trial, including 20 patients with metabolic dysfunction–associated steatohepatitis (either liver biopsy evidence of metabolic dysfunction–associated steatohepatitis or an ultrasound, CT, or MRI study showing hepatic steatosis and one of the following: Fibrosis-4 Index ≥1.45 or vibration-controlled transient elastography measurement of liver stiffness >8.2 kPA or FibroScan-AST score >0.35) by using Noom app or 20 controls with the standard of care. Noom is a self-management app that guides calorie consumption, exercise, and stress relief.…”

“…These studies reveal the future of apps—point-of-care, just-in-time behavioral interventions that can be customized to the patient’s needs, maximizing effectiveness through digital phenotyping. 3 , 5 , 6 Pilot studies should now give way to larger, multicenter evaluations designed for generalizable effects. Randomization, thoughtful control arms, and enrollment of sufficient power to detect meaningful effects are needed.…”