Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD

NCT06352177 | Withdrawn DMC

• 1 other identifier: protocol-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinically significant liver fat loss

  Proportion of participants achieving \>30% relative reduction in MRI-PDFF after Wk. 16.

  16 weeks

Secondary Outcomes (33)

• Sustained clinically significant body weight loss

  16 weeks

• Sustained clinically significant body weight loss

  52 weeks

• Liver fat and liver stiffness using imaging analysis

  16 weeks

• Liver fat and liver stiffness using imaging analysis

  16 weeks

• Liver fat and liver stiffness using imaging analysis

  16 weeks

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants in this group will receive counseling about best MASLD clinical practices in accordance with AASLD and ACSM practice guidelines Because in-office hepatology counseling for lifestyle intervention occurs every 12-24 wks,standard counseling will occur at each in-person visit. Mediterranean-informed, hypocaloric dietary counseling will be provided by a study investigator, with specific instructions to limit carbohydrates and saturated fat and enrich dietary intake with high fiber and unsaturated fats. Physical activity goals of 150 min/wk. of moderate intensity of 75 min/wk. of vigorous intensity activity will be suggested. To reinforce this education and promote self-monitoring, participants in this group will also receive a digital scale and fitness activity tracker.

Intervention

EXPERIMENTAL

This commercially available program (Noom Weight) promotes clinically significant body weight loss and behavior change in multiple populations including our pilot study in individuals with MASLD. 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.

Other: Noom Weight Application

Interventions

Noom Weight Application OTHER

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.

Also known as: NW

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years at the time of signing informed consent
• MASH defined by any of the following within 12-months prior to SV (V1):
• Liver biopsy with definitive MASH with NAS \>4 with \>1 in each component (i.e., steatosis, lobular inflammation, ballooning) or;
• Imaging study (e.g., ultrasound) with hepatic steatosis and one of the following:
• i) FIB-4 \>1.3 or; ii) ELF test \>7.7 or; iii) VCTE measured liver stiffness \>8kPa or FAST score \>0.35 or; iv) MRE measured liver stiffness \>2.55kPa or MAST score \>0.165
• Possession of a smartphone (iPhone6s or newer with iOS version 15.6 or above; Android device with Android version 6 or above)
• If participants are on GLP1-RA or other regulatory agency approved anti-obesity medication (e.g., orlistat, buproprion/naltrexone, phentermine-topiramate, phentermine, loreaserin), the medication dose must be stable (no change in dose) for the 3 mos. before SV.
• Stable body weight for 3 mos. before screening visit defined as \<5% weight loss or weight gain

You may not qualify if:

• Recent (within 3 mos. of SV) participation in lifestyle intervention program or use of supplements marked for weight loss or appetite.
• Plans to undergo bariatric surgery or initiate anti-obesity medication.
• History of cirrhosis and/or hepatic decompensation (e.g., ascites, encephalopathy, variceal bleeding)
• Liver disease of other etiologies (e.g., viral hepatitis), including liver transplantation
• History of excessive alcohol consumption defined by self-report (men \>30g/d or women \>20g/d), AUDIT-C \>4 or PETH \> 20ug/L
• History of malignancy within last 5 yrs., excluding successful treatment of non-melanoma skin cancer
• Participant in any clinical trial or use of drugs under investigation for treatment of MASH within 3 mos. of SV
• History of type 1 diabetes or uncontrolled type 2 diabetes (A1c \>9.5% or changes in diabetes medication doses within 3 mos. of SV)
• Recent (within 3 mos. of SV) initiation or change in dose of medications used to treat MASH (e.g., vitamin E, pioglitazone)
• Recent (within 3 mos. of SV) use of drugs associated with the development of steatotic liver disease (e.g., methotrexate, tamoxifen)
• Known or suspected history of drug abuse within the last 2 years prior to SV at the discretion of study investigator
• Vulnerable participants (e.g., protected adults under guardianship or committed to an institution by governmental or judicial order)
• Participants who cannot communicate with the study investigators or use digital technology reliably
• Severe medical comorbidities that may hinder study participation at the discretion of study investigator
• Current pregnancy or plans to become pregnant during the study period

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Compliance Specialist, Penn State Health

Model Details: 2:1 randomization

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: April 8, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We agree to deposit all data into the repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the main outcome data for publication. The data shared will be archived and available on the platform for request by researchers for a minimum of 10 years after contribution. Data will be made accessible no later than the time of our associated publication or the end of the grant period (whichever comes first).
• Access Criteria: We will make the data available via the Vivli platform. Vivli is a non-profit clinical research data sharing platform that has been created to meet the needs of researchers who use and produce clinical research data worldwide. Using the Vivli platform, researchers can share or access anonymized data using a managed access process. To access anonymized individual patient-level data (IPD) arising from this project, users complete the Vivli data request form and sign the Vivli Data Use Agreement, which limits subsequent use to the terms of the approved proposal and requires that users maintain data security, and refrain from any attempts to re-identify research participants or engage in unauthorized uses of the data. Vivli will then make the data available via secure download. Researchers have a requirement to publish their findings as part of the Data Use Agreement and once the project is complete, must confirm that the original data and documents have been destroyed.