Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Better Therapeutics

Status: Completed

Conditions: Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver

Treatments: Device: BT-NCBT-00X

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05357248

BT-NCBT-00x

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Intervention- BT-NCBT-00x

Experimental group

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. 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

Treatment:

Device: BT-NCBT-00X