Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

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.

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver
• Intervention / Treatment: Device: BT-NCBT-00X

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Liver Health
    • Peoria, Arizona, United States, 85381
      • Arizona Liver Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention- BT-NCBT-00x; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Better Therapeutics
• Collaborators: Arizona Liver Health

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: BT-NCBT-00x

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No