Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06380920

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionWeight Loss, Body Fat Rate Loss, Body Composition Change

Full registry criteria

Inclusion Criteria: * 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) Exclusion Criteria: * Any history of cancer * Unstable mental status * Uncooperative subject * Complex clinical comorbidities, such as heart failure, end-stage renal disease, etc. * Severe physical disability

Treatments and study arms

"AI Mindful Eating" App

Device

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, in place of medication, to alleviate food addiction and proper nutrition intake during proper metabolic conditions and time, which are coordinated via AI.

Outpatient regular follow-up

Behavioral

Outpatient regular follow-up

Primary outcomes

weight change0, 3 and 6 months after intervened

Body composition measured by BIA or DXA

Study locations

1 locations were listed when this page was built. The first 40 are shown.

National Cheng Kung University Hospital🇹🇼 Tainan, Taiwan

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