Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

• Sponsor: Better Therapeutics (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05357248
• Collaborator: Arizona Liver Health (Other)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 3.7
• Patients Per Site: 10
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver	Device: BT-NCBT-00X	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASHThis single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH
• Masking: None (Open Label)
• Masking Description: open label
• Primary Purpose: Treatment
• Official Title: Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
• Actual Study Start Date: Apr 10, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. change in percent liver fat [90 days]

   Mean change in percent liver fat from baseline to end of treatment in participants with baseline PDFF ≥ 10%, as measured by MRI-PDFF.

Secondary Outcome Measures

1. Change in Liver Fat- all participants [90 days]

   Mean change in liver fat from baseline to end of treatment in all participants, as measured by MRI-PDFF

2. Reduction in Percent Liver fat [90 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Liver Health	Chandler	Arizona	United States	85224
2	Arizona Liver Health	Peoria	Arizona	United States	85381

Sponsors and Collaborators

• Better Therapeutics
• Arizona Liver Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Better Therapeutics
• ClinicalTrials.gov Identifier: NCT05357248
• Other Study ID Numbers: BT-NCBT-00x
• First Posted: May 2, 2022
• Last Update Posted: May 5, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 5, 2022