Status:
COMPLETED
Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
Lead Sponsor:
Better Therapeutics
Collaborating Sponsors:
Arizona Liver Health
Conditions:
Non-alcoholic Steatohepatitis
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This single arm interventional cohort study is designed to explore the feasibility of using BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with NAFLD or NASH over ...
Detailed Description
The treatment, BT-NCBT-00x, consists of a software as a medical device developed by the study Sponsor, Better Therapeutics. It delivers treatment to participants with cardiometabolic disease, using be...
Eligibility Criteria
Inclusion
- Diagnosis of NAFLD or NASH
- At least 2 doses of the COVID-19 Vaccine, per self report
- Possession of a smartphone capable of running the Bt\_NCBT-00x application
- BMI \>/= 30 at the screening visit
- Fibroscan CAP \>300 dB/m collected at screening visit
- Completion of baseline MRI-PDFF
- Understand written and spoken english
Exclusion
- Inability to read and understand english
- unstable or life-threatening medical illness
- weight loss of greater than 10lbs within the last 90 days
- pregnant or planning to become pregnant women
- concurrent enrollment in any other interventional clinical trial
- presumed or confirmed COVID-19 diagnosis within 30 days prior to study enrollment
- change in medication regimen of hormonal contraceptives, anti-hyperglycemic medications, mental or emotional disorder medications, corticosteroids, thyroid hormones, Tamoxifen or Methotrexate within 90 days
Key Trial Info
Start Date :
April 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05357248
Start Date
April 10 2022
End Date
December 7 2022
Last Update
December 13 2022
Active Locations (2)
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1
Arizona Liver Health
Chandler, Arizona, United States, 85224
2
Arizona Liver Health
Peoria, Arizona, United States, 85381