Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

NCT05357248 | Completed FDA Device

• 1 other identifier: BT-NCBT-00x
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Liver Fat- all participants

  90 days

• Reduction in Percent Liver fat

  90 days

Study Arms (1)

Intervention- BT-NCBT-00x

EXPERIMENTAL

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

Interventions

BT-NCBT-00X 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.

Intervention- BT-NCBT-00x

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Better Therapeutics: lead
• Arizona Liver Health: collaborator

Study Sites (2)

Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

Arizona Liver Health

Peoria, Arizona, 85381, United States

Location

Related Publications (1)

• 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.

  PMID: 39132187 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: April 10, 2022
• Primary Completion: November 11, 2022
• Study Completion: December 7, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)