Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Better Therapeutics22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

BT-NCBT-00XDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Arizona Liver Health

Chandler, Arizona, United States

Arizona Liver Health

Peoria, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 90 days

Secondary Outcomes

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

Time frame: 90 days

Reduction in Percent Liver fat

Percent of participants who achieve ≥ 30% change in PDFF from baseline to end of treatment

Time frame: 90 days

Data from ClinicalTrials.gov

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