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Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

NCT ID: NCT05357248

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2022-12-07

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label

Study Groups

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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

Group Type EXPERIMENTAL

BT-NCBT-00X

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arizona Liver Health

UNKNOWN

Sponsor Role collaborator

Better Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Liver Health

Chandler, Arizona, United States

Site Status

Arizona Liver Health

Peoria, Arizona, United States

Site Status

Countries

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United States

References

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Alkhouri N, Edwards K, Berman M, Finn H, Escandon R, Lupinacci P, Guthrie N, Coste A, Topete J, Noureddin M. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Adv. 2023 Oct 1;3(1):9-16. doi: 10.1016/j.gastha.2023.08.019. eCollection 2024.

Reference Type DERIVED
PMID: 39132187 (View on PubMed)

Other Identifiers

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BT-NCBT-00x

Identifier Type: -

Identifier Source: org_study_id