Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Conditions
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Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver

Intervention / Treatment
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* Device: BT-NCBT-00X


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention- BT-NCBT-00x<br>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. BT-NCBT-00x is accessed via the participants' smartphone after downloading from the phone's corresponding app store. Participants will receive behavioral support by the Better Therapeutics patient services team in the form of phone calls as necessary or requested by the patient | Device: BT-NCBT-00X<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in percent liver fat | Mean change in percent liver fat from baseline to end of treatment in participants with baseline PDFF ≥ 10%, as measured by MRI-PDFF. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Fat- all participants | Mean change in liver fat from baseline to end of treatment in all participants, as measured by MRI-PDFF | 90 days | 
| Reduction in Percent Liver fat | Percent of participants who achieve ≥ 30% change in PDFF from baseline to end of treatment | 90 days |