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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380920
• Other study ID #: Digital Health App
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: National Cheng-Kung University Hospital
• Contact: Chih-Hsing Wu, MD
• Phone: 886-6-2353535
• Email: paulo[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Device:
• "AI Mindful Eating" App
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.

Behavioral:
• Outpatient regular follow-up
Outpatient regular follow-up

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change	Body composition measured by BIA or DXA	0, 3 and 6 months after intervened
Secondary	Parameters of Metabolic syndrome	Waist circumference was measured at mid-way of abdomen during end-expiratory phase	0, 3 and 6 months after intervened