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Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BT-NCBT-00X

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arizona Liver Health
Arizona Liver Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention- BT-NCBT-00x

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Reduction in Percent Liver fat

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

Full Information

NCT ID

NCT05357248

First Posted

April 27, 2022

Last Updated

December 12, 2022

Sponsor

Better Therapeutics

Collaborators

Arizona Liver Health

1. Study Identification

Unique Protocol Identification Number

NCT05357248

Brief Title

Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Official Title

Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

April 10, 2022 (Actual)

Primary Completion Date

November 11, 2022 (Actual)

Study Completion Date

December 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Better Therapeutics

Collaborators

Arizona Liver Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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 NASH

Masking

None (Open Label)

Masking Description

open label

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention- BT-NCBT-00x

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

BT-NCBT-00X

Intervention Description

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.

Primary Outcome Measure Information:

Title

change in percent liver fat

Description

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

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Change in Liver Fat- all participants

Description

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

Time Frame

90 days

Title

Reduction in Percent Liver fat

Description

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

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Arizona Liver Health

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Arizona Liver Health

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

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