NCT06352177

Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD

Efficacy of a Novel Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH. People who have MASH, the progressive subtype of MASLD, have the highest risk for liver disease progression and poor outcomes, including cirrhosis and hepatocellular carcinoma, and greater overall mortality. Thus, these participants are expected to experience the greatest benefit from treatment. This is a randomized, controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care. The study includes a screening period (up to 2 wks.) followed by randomization, 52-wk treatment period and 12-wk follow-up period (total duration up to 64 wks.).

Conditions

• NASH
• NASH - Nonalcoholic Steatohepatitis
• Liver Diseases

Interventions

Type	Name	Description
OTHER	Noom Weight Application	This commercially available program (Noom Weight) promotes clinically significant body weight loss and behavior change in multiple populations. The program is delivered through a smartphone application and includes self-monitoring and feedback features for diet, physical activity, and body weight, as well as digital access to a 1:1 behavior change coach, a support group facilitated by a health coach, and a curriculum delivered via daily articles focused on nutrition, physical activity, and sustainable behavioral change.

Timeline

• Start date: 2025-09-01
• Primary completion: 2030-01-01
• Completion: 2030-04-01
• First posted: 2024-04-08
• Last updated: 2025-07-25