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临床试验/NCT06380920
NCT06380920进行中(未招募)不适用

Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
weight change

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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

Experimental

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 (Device)

Case

Experimental

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 (Behavioral)

Control

Placebo Comparator

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 (Behavioral)

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chih-Hsing Wu

Professor

National Cheng-Kung University Hospital

研究点 (1)

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