Weight LossNCT06380920
Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example
A study testing "AI Mindful Eating" App and Outpatient regular follow-up in people with Weight Loss and Body Fat Rate Loss, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss, Body Fat Rate Loss, Body Composition Change
- What is being tested?
- "AI Mindful Eating" App and Outpatient regular follow-up
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Any history of cancer
- Unstable mental status
- Uncooperative subject
- Complex clinical comorbidities, such as heart failure, end-stage renal disease, etc.
- Severe physical disability
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Weight Loss, Body Fat Rate Loss, Body Composition Change
- Being tested
- "AI Mindful Eating" App, Outpatient regular follow-up
- Keywords
- obesity, assistive intelligence, APP, weight control, cognitive behavior therapy
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"AI Mindful Eating" AppDevice
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-upBehavioural
Outpatient regular follow-up
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | 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 Receives: Device: "AI Mindful Eating" App; Behavioral: Outpatient regular follow-up |
| Control | Placebo comparator | 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 Receives: Behavioral: Outpatient regular follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Body composition measured by BIA or DXA
Measured: 0, 3 and 6 months after intervened
Secondary outcomes (1)
Parameters of Metabolic syndrome
Waist circumference was measured at mid-way of abdomen during end-expiratory phase
Measured: 0, 3 and 6 months after intervened
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start20 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Hsing Wu, National Cheng-Kung University Hospital
- Investigators
- Chih-Hsing Wu, MD, Study director, Department of Family Medicine, National Cheng Kung Univ Hosp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380920
- Sponsor's protocol ID
- Digital Health App
- Status last verified
- May 2025
- First submitted
- 18 Apr 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example
- ClinicalTrials.gov ID
- NCT06380920
- Acronym / sponsor ID
- Digital Health App
- Conditions
- Weight Loss, Body Fat Rate Loss, Body Composition Change
- Keywords
- obesity, assistive intelligence, APP, weight control, cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Device: "AI Mindful Eating" App, Behavioral: Outpatient regular follow-upintervened 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 |
| Control | Placebo comparator | Behavioral: Outpatient regular follow-upintervened 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (5 listed)
- Any history of cancer
- Unstable mental status
- Uncooperative subject
- Complex clinical comorbidities, such as heart failure, end-stage renal disease, etc.
- Severe physical disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "AI Mindful Eating" AppThe 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. | Device | Case |
| Outpatient regular follow-upOutpatient regular follow-up | Behavioural | Case, Control |
Primary outcome
weight change
Time frame: 0, 3 and 6 months after intervened
Body composition measured by BIA or DXA
1 secondary outcome
Parameters of Metabolic syndrome
Time frame: 0, 3 and 6 months after intervened
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Hsing Wu, MD study director
Department of Family Medicine, National Cheng Kung Univ Hosp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "AI Mindful Eating" App and Outpatient regular follow-up in people with Weight Loss and Body Fat Rate Loss, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: 0, 3 and 6 months after intervened). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.