Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Conditions
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 a 3 month intervention.
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 behavioral therapy that targets individual behaviors related to improving dietary quality and physical activity. The study evaluates the use of this behavioral therapy and its effect on clinical measures such as percent liver fat as measured by MRI-PDFF, and Fibroscan Controlled Attenuation Parameter score, liver stiffness as measured by Fibroscan Vibration Controlled Transient Elastography in kPA, body weight and ALT. Participants in this feasibility study will have access to the treatment for 3- months.
Interventions
DEVICEBT-NCBT-00X
the intervention group will consist of 20 patients to receive the BT-NCBT-00X treatment for 90 days. They will receive a baseline MRI-PDFF, Fibroscan and have the tests repeated at 90 days.
Sponsors
Arizona Liver Health
Better Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label
Intervention model description
This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in percent liver fat | 90 days | Mean change in percent liver fat from baseline to end of treatment in participants with baseline PDFF ≥ 10%, as measured by MRI-PDFF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Fat- all participants | 90 days | Mean change in liver fat from baseline to end of treatment in all participants, as measured by MRI-PDFF |
| Reduction in Percent Liver fat | 90 days | Percent of participants who achieve ≥ 30% change in PDFF from baseline to end of treatment |
Countries
United States
Outcome results
None listed