Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 6:59 PM
Study NCT ID:
NCT03465306
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2018-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This study is been designed to have pre, post, and follow-up phases.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Weight difference'}], 'secondaryOutcomes': [{'measure': 'weight and height will be combined to report BMI in kg/m^2', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'BMI difference'}, {'measure': 'Fat percent', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Fat percent difference'}, {'measure': 'Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Psychological index, total scores range from 10\\~40, higher the score lower the self-esteem.'}, {'measure': 'Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Psychological index, total scores range from 8\\~48, higher the score lower the satisfaction to self-body image.'}, {'measure': 'Dutch Eating Behavior Questionnaire (DEBQ)', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Psychological index, total scores range from 33\\~165, higher the score more problems in eating behavior.'}, {'measure': 'Yale Food Addiction Scale (YFAS)', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Psychological index, total scores range from 0\\~7, higher the score more expected to have food addiction.'}, {'measure': 'Trait Anxiety Inventory (TAI)', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Psychological index, total scores range from 20\\~80, higher the score higher in feelings of anxiety.'}, {'measure': 'Korean Beck Depression Inventory (K-BDI)', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Psychological index, total scores range from 0\\~63, higher the score higher in feelings of depressed.'}, {'measure': 'Automatic Thoughts Questionnaire-30 (ATQ-30)', 'timeFrame': 'Baseline, at 8 weeks, at 6 months', 'description': 'Psychological index, total scores range from 30\\~150, higher the score higher tendency to have negative automatic thoughts.'}, {'measure': 'the result of cholesterol total', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'the result of triglycerides (TG)', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'the result of gamma-glutamyl transferase (GGT)', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'the result of glucose', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'the result of alanine aminotransferase (ALT)', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'the result of aspartate aminotransferase (AST)', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'the result of insulin', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'the result of leptin', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Biological index'}, {'measure': 'Buffet index', 'timeFrame': 'Baseline, at 8 weeks', 'description': 'Buffet test, total scores range from 0\\~100, higher the score better in healthy food choice and amount of intake.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Cognitive Behavioral Therapy'], 'conditions': ['Search MeSH']}, 'referencesModule': {'references': [{'pmid': '38375882', 'type': 'DERIVED', 'citation': 'Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.'}, {'pmid': '38062157', 'type': 'DERIVED', 'citation': 'Kim M, Lee S, Cho E, Hong KW, You SJ, Choi HJ. CETP and APOA2 polymorphisms are associated with weight loss and healthy eating behavior changes in response to digital lifestyle modifications. Sci Rep. 2023 Dec 7;13(1):21615. doi: 10.1038/s41598-023-48823-w.'}, {'pmid': '34184991', 'type': 'DERIVED', 'citation': 'Kim M, Yang J, Ahn WY, Choi HJ. Machine Learning Analysis to Identify Digital Behavioral Phenotypes for Engagement and Health Outcome Efficacy of an mHealth Intervention for Obesity: Randomized Controlled Trial. J Med Internet Res. 2021 Jun 24;23(6):e27218. doi: 10.2196/27218.'}, {'pmid': '32352391', 'type': 'DERIVED', 'citation': 'Kim M, Kim Y, Go Y, Lee S, Na M, Lee Y, Choi S, Choi HJ. Multidimensional Cognitive Behavioral Therapy for Obesity Applied by Psychologists Using a Digital Platform: Open-Label Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 30;8(4):e14817. doi: 10.2196/14817.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to develop and validate the effects of a new cognitive behavioral therapy (CBT) using digital healthcare mobile apps such as Noom Coach and InBody.', 'detailedDescription': 'Seventy female participants whose BMI scores were above 23 and who had no other clinical problem except obesity were randomized into an experimental and a control group. Forty-five people in the experimental group were connected with the therapist using digital healthcare apps, so they got daily feedbacks and assignments for 8 weeks. Twenty-five people in the control group also used digital healthcare apps but they were asked to do self-care without intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SIMS score ranks over high 20% of total\n\nExclusion Criteria:\n\n* Had been prescribed with psychological problems or medical problems.'}, 'identificationModule': {'nctId': 'NCT03465306', 'briefTitle': 'Developing and Validating Clinical Efficacy for Obesity Digital CBT Model', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Developing and Validating Clinical Efficacy for Obesity Digital CBT Model', 'orgStudyIdInfo': {'id': 'ObesityCBT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive digital CBT', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard digital CBT', 'interventionNames': ['Device: Self-guided']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive-behavioral therapy is a psycho-social intervention that is the most widely used evidence-based practice for improving mental health and requires active interactions between the participants and a therapist or coach.', 'armGroupLabels': ['Intensive digital CBT']}, {'name': 'Self-guided', 'type': 'DEVICE', 'description': 'Self-guided refers to any contact between the participants and a therapist or coach.', 'armGroupLabels': ['Standard digital CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Noom Inc.', 'class': 'INDUSTRY'}, {'name': 'InBody', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}