Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06380920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight change', 'timeFrame': '0, 3 and 6 months after intervened', 'description': 'Body composition measured by BIA or DXA'}], 'secondaryOutcomes': [{'measure': 'Parameters of Metabolic syndrome', 'timeFrame': '0, 3 and 6 months after intervened', 'description': 'Waist circumference was measured at mid-way of abdomen during end-expiratory phase'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'assistive intelligence', 'APP', 'weight control', 'cognitive behavior therapy'], 'conditions': ['Weight Loss', 'Body Fat Rate Loss', 'Body Composition Change']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n\nExclusion Criteria:\n\n* Any history of cancer\n* Unstable mental status\n* Uncooperative subject\n* Complex clinical comorbidities, such as heart failure, end-stage renal disease, etc.\n* Severe physical disability'}, 'identificationModule': {'nctId': 'NCT06380920', 'briefTitle': 'Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example', 'orgStudyIdInfo': {'id': 'Digital Health App'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case', 'description': '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', 'interventionNames': ['Device: "AI Mindful Eating" App', 'Behavioral: Outpatient regular follow-up']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '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', 'interventionNames': ['Behavioral: Outpatient regular follow-up']}], 'interventions': [{'name': '"AI Mindful Eating" App', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Case']}, {'name': 'Outpatient regular follow-up', 'type': 'BEHAVIORAL', 'description': 'Outpatient regular follow-up', 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chih-Hsing Wu, MD', 'role': 'CONTACT', 'email': 'paulo@mail.ncku.edu.tw', 'phone': '886-6-2353535', 'phoneExt': '5200'}, {'name': 'Chin-Sung Chang, MD', 'role': 'CONTACT', 'email': 'chinsong@mail.ncku.edu.tw', 'phone': '886-6-2353535', 'phoneExt': '5200'}], 'overallOfficials': [{'name': 'Chih-Hsing Wu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Family Medicine, National Cheng Kung Univ Hosp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chih-Hsing Wu', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}