Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example
概览
- 阶段
- 不适用
- 干预措施
- "AI Mindful Eating" App
- 疾病 / 适应症
- Weight Loss
- 发起方
- National Cheng-Kung University Hospital
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- weight change
- 状态
- 进行中(未招募)
- 最后更新
- 3个月前
概览
简要总结
This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an "AI Mindful Eating" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on "gut-brain-axis", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention.
研究者
Chih-Hsing Wu
Professor
National Cheng-Kung University Hospital
入排标准
入选标准
- •Obese subjects (BMI\>= \>= 27 kg/m2) with age 18 year-old and less than 65 y/o over will be considered (M/F= 1:1)
排除标准
- •Any history of cancer
- •Unstable mental status
- •Uncooperative subject
- •Complex clinical comorbidities, such as heart failure, end-stage renal disease, etc.
- •Severe physical disability
研究组 & 干预措施
Case
intervened with App/CBT/MB-EAT groups by a randomized control trial design for 9 months and periodically surveyed as well as 0, 3, and 6 months after intervened
干预措施: "AI Mindful Eating" App
Case
intervened with App/CBT/MB-EAT groups by a randomized control trial design for 9 months and periodically surveyed as well as 0, 3, and 6 months after intervened
干预措施: Outpatient regular follow-up
Control
intervened without App/CBT/MB-EAT groups by a randomized control trial design for 9 months and periodically surveyed as well as 0, 3, and 6 months after intervened
干预措施: Outpatient regular follow-up
结局指标
主要结局
weight change
时间窗: 0, 3 and 6 months after intervened
Body composition measured by BIA or DXA
次要结局
- Parameters of Metabolic syndrome(0, 3 and 6 months after intervened)