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

January 27, 2026 updated by: Chih-Hsing Wu, National Cheng-Kung University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Outpatient regular follow-up
Outpatient regular follow-up
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.
Placebo Comparator: 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
Behavioral: Outpatient regular follow-up
Outpatient regular follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight change
Time Frame: 0, 3 and 6 months after intervened
Body composition measured by BIA or DXA
0, 3 and 6 months after intervened

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameters of Metabolic syndrome
Time Frame: 0, 3 and 6 months after intervened
Waist circumference was measured at mid-way of abdomen during end-expiratory phase
0, 3 and 6 months after intervened

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Study Director: Chih-Hsing Wu, MD, Department of Family Medicine, National Cheng Kung Univ Hosp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Digital Health App

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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