Clinical trial NCT05357248: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Steatohepatitis
Non-Alcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver
Lead sponsor: Better Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Arizona Liver Health
First posted: 2022-05-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 NASH
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in percent liver fat
timeFrame: 90 days
Secondary outcomes:
measure: Change in Liver Fat- all participants
timeFrame: 90 days
measure: Reduction in Percent Liver fat
timeFrame: 90 days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Liver Health
state: Arizona
city: Peoria
country: United States
facility: Arizona Liver Health
state: Arizona
Study officials:
References: