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NCT06380920Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
18 Apr 2024
Start date
20 Nov 2024
Primary completion date
31 Dec 2026
Lead sponsor
National Cheng-Kung University Hospital
Diseases
Obesity
NCT number
NCT06380920

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 20 Nov 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any history of cancer
  • Complex clinical comorbidities, such as heart failure, end-stage renal disease, etc.

Other

  • Unstable mental status
  • Uncooperative subject
  • Severe physical disability

Who the study is looking for

  • 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)

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.