NCT05357248

Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Better Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	BT-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.

Timeline

• Start date: 2022-04-10
• Primary completion: 2022-11-11
• Completion: 2022-12-07
• First posted: 2022-05-02
• Last updated: 2022-12-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study