Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- change in percent liver fat
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
change in percent liver fat
时间窗: 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.
次要结局
- Change in Liver Fat- all participants(90 days)
- Reduction in Percent Liver fat(90 days)