protocolSection identificationModule nctId: NCT06352177, orgStudyIdInfo id: protocol-1, briefTitle: Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD, acronym: ENLIGHTEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2030-08-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: 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, 48-wk treatment period and 12-wk follow-up period (total duration up to 62 wks.)., conditionsModule conditions: NASH, conditions: NASH - Nonalcoholic Steatohepatitis, conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 50/50 randomization, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Noom Weight Application, outcomesModule primaryOutcomes measure: Clinically significant liver fat loss, secondaryOutcomes measure: Sustained clinically significant body weight loss, secondaryOutcomes measure: Sustained clinically significant body weight loss, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False