Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD

Launched by MILTON S. HERSHEY MEDICAL CENTER · Apr 1, 2024

Keywords

ClinConnect Summary

The ENLIGHTEN study is looking at a new digital program designed to help people with a liver condition called MASH, which is a serious type of liver disease that can lead to more severe health issues. This study will compare the effects of this digital lifestyle intervention with standard care to see which is more effective in improving health outcomes for participants. If you’re between 18 and 75 years old and have been diagnosed with MASH, you might be eligible to participate. To qualify, you’ll need to have a smartphone and meet certain health criteria related to your liver condition.

Participants in the study will go through a screening process, followed by a year of treatment, and then a 12-week follow-up. During this time, you’ll receive guidance and support through the digital program, which aims to help you make healthier lifestyle choices. The study is not yet recruiting participants, but if you’re interested, it could be a valuable opportunity to receive support for managing your liver health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 years at the time of signing informed consent
• 2. MASH defined by any of the following within 12-months prior to SV (V1):
• • 1. Liver biopsy with definitive MASH with NAS \>4 with \>1 in each component (i.e., steatosis, lobular inflammation, ballooning) or;
• 2. 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
• • 3. Possession of a smartphone (iPhone6s or newer with iOS version 15.6 or above; Android device with Android version 6 or above)
• • 4. 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.
• • 5. Stable body weight for 3 mos. before screening visit defined as \<5% weight loss or weight gain
• Exclusion Criteria:
• • 1. Recent (within 3 mos. of SV) participation in lifestyle intervention program or use of supplements marked for weight loss or appetite.
• • 2. Plans to undergo bariatric surgery or initiate anti-obesity medication.
• • 3. History of cirrhosis and/or hepatic decompensation (e.g., ascites, encephalopathy, variceal bleeding)
• • 4. Liver disease of other etiologies (e.g., viral hepatitis), including liver transplantation
• • 5. History of excessive alcohol consumption defined by self-report (men \>30g/d or women \>20g/d), AUDIT-C \>4 or PETH \> 20ug/L
• • 6. History of malignancy within last 5 yrs., excluding successful treatment of non-melanoma skin cancer
• • 7. Participant in any clinical trial or use of drugs under investigation for treatment of MASH within 3 mos. of SV
• • 8. History of type 1 diabetes or uncontrolled type 2 diabetes (A1c \>9.5% or changes in diabetes medication doses within 3 mos. of SV)
• • 9. Recent (within 3 mos. of SV) initiation or change in dose of medications used to treat MASH (e.g., vitamin E, pioglitazone)
• • 10. Recent (within 3 mos. of SV) use of drugs associated with the development of steatotic liver disease (e.g., methotrexate, tamoxifen)
• • 11. Known or suspected history of drug abuse within the last 2 years prior to SV at the discretion of study investigator
• • 12. Vulnerable participants (e.g., protected adults under guardianship or committed to an institution by governmental or judicial order)
• • 13. Participants who cannot communicate with the study investigators or use digital technology reliably
• • 14. Severe medical comorbidities that may hinder study participation at the discretion of study investigator
• • 15. Current pregnancy or plans to become pregnant during the study period