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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06380920
Enrollment
100
Registered
2024-04-24
Start date
2024-11-20
Completion date
2026-12-31
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Composition Change, Body Fat Rate Loss, Weight Loss

Keywords

obesity, assistive intelligence, APP, weight control, cognitive behavior therapy

Brief 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.

Interventions

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.

BEHAVIORALOutpatient regular follow-up

Outpatient regular follow-up

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
weight change0, 3 and 6 months after intervenedBody composition measured by BIA or DXA

Secondary

MeasureTime frameDescription
Parameters of Metabolic syndrome0, 3 and 6 months after intervenedWaist circumference was measured at mid-way of abdomen during end-expiratory phase

Countries

Taiwan

Contacts

STUDY_DIRECTORChih-Hsing Wu, MD

Department of Family Medicine, National Cheng Kung Univ Hosp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026