Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357248
• Other study ID #: BT-NCBT-00x
• Status: Completed
• Phase: N/A
• Start date: April 10, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: December 2022
• Source: Better Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 7, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Arizona Liver Health	Chandler	Arizona
United States	Arizona Liver Health	Peoria	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Better Therapeutics	Arizona Liver Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Reduction in Percent Liver fat	Percent of participants who achieve = 30% change in PDFF from baseline to end of treatment	90 days