Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT05892861
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2023-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2023-05-14', 'studyFirstSubmitQcDate': '2023-05-28', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The change of the awareness of complication and health behavior from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': '8 questions about the complications of type 2 DM (stroke, blind, wood healing, amputation, CKD, CAD, hypoglycemia, and Dementia) by Linkert scale (the total score range is 8 to 40). Higher scores mean better change.'}, {'measure': 'The change of HbA1C from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': 'biomedical data after phlebotomy (HbA1C in %), Higher scores mean worse change.'}, {'measure': 'The change of total cholesterol from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': 'biomedical data after phlebotomy (total cholesterol in mg/dl). Higher scores mean worse change.'}, {'measure': 'The change of triglyceride from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': 'biomedical data after phlebotomy (triglyceride in mg/dl). Higher scores mean worse change.'}, {'measure': 'The change of low-density lipoprotein cholesterol from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': 'biomedical data after phlebotomy (low-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change.'}, {'measure': 'The change of high-density lipoprotein cholesterol from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': 'biomedical data after phlebotomy (high-density lipoprotein cholesterol in mg/dl). Higher scores mean worse change.'}, {'measure': 'The change of health behavior awareness from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': '9 questions about health behavior (body weight measurement, foot care, blood pressure measurement, drug adherence, diet adherence, calculation of intake amount by hand when eating, smoking habits, drinking habits, and exercise habits) by Linkert scale (total score range is 9 to 45). Higher scores mean better change.'}, {'measure': 'The change of health behavior frequency per week from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': '9 questions about health behavior (body weight measurement, foot care, blood pressure measurement, drug adherence, diet adherence, calculation of intake amount by hand when eating, smoking habits, drinking habits, and exercise habits) by Linkert scale (total score range is 9 to 45). Higher scores mean better change.'}], 'primaryOutcomes': [{'measure': 'The change of cognitive function from baseline at 3 and 6 months', 'timeFrame': '12th week & 24 week', 'description': 'Saint Louis University Mental State examination, the total score range is 0\\~30. Higher scores mean better change.'}], 'secondaryOutcomes': [{'measure': 'The change of dietary control belief from baseline at 3 and 6 months', 'timeFrame': '12th week and 24th week', 'description': '12 questions by Linkert scale (4 questions about dietary mastery items and 8 questions about dietary perceived constraints items) about dietary control belief(the total score range is 12 to 60) Higher scores mean better change.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes Mellitus', 'Cognitive Impairment, Mild']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to \\[learn about cognitive stimulation by multidomain dietary education including the dietary board game via LINE in non-dementic type 2 diabetic adults. The main questions it aims to answer are:\n\n\\[Question 1: Could multi-domain dietary education as cognitive stimulation improve cognitive function?\\] \\[Question 2: Could multi-domain dietary education improve dietary control belief ?\\] \\[Question 3: Could multi-domain dietary education improve health behavior?\\] \\[Question 4\\]: Could multi-domain dietary education improve HbA1C, and lipid profile? Participants of experimental A group will receive a video about lifestyle education 5 minutes weekly for 3 weeks, a dietary board game 10 minutes weekly for 10 weeks, and a 24-hour dietary recall record 2 times weekly for 7 weeks. And participants of the experimental B group receive the usual clinical treatment. Then experimental A and Experimental B groups will cross over 12 weeks later.\n\nResearchers will compare the effect of intervention between the experimental A group and the experimental B group.', 'detailedDescription': 'Cognitive function was measured by the Saint Louis University Mental State (SLUMS) score. And we exclude the dementia group according to the SLUMS definition (\\<21 if the participants graduated from senior high school or above, \\<20 if the education level below senior high school).\n\nExperimental group A received 10-week curriculum from 1st week to 10th week, and receive d usual clinical care from 13th week to 22th week. Experimental B group received usual clinical care from 1st week to 10th week, and received 10-week curriculum from 13th week to 22th week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The onset age of Diabetes Mellitus is more than 20 years old\n* Diagnosis of Diabetes according to past history including type 2 diabetes mellitus or drug history including oral anti-diabetic drugs\n\nExclusion Criteria:\n\n* SLUMS meets the Dementia definition.\n* HbA1C ≥ 10.0%\n* Rejected our study.\n* History of stroke.\n* History of depression.\n* History of psychiatric disease.\n* Visual impairment.\n* Hearing impairment.\n* Can't understand the informed consent"}, 'identificationModule': {'nctId': 'NCT05892861', 'briefTitle': 'The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults', 'organization': {'class': 'OTHER', 'fullName': 'National Kaohsiung Normal University'}, 'officialTitle': 'The Effect of Multidomain Dietary Education in Type 2 Diabetic Adults', 'orgStudyIdInfo': {'id': '21-065-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multi domain dietary education as cognitive stimulation', 'description': 'video lifestyle education, board game, and 24-hour dietary recall record from 1st week to 10th week as cognitive stimulation.', 'interventionNames': ['Behavioral: cognitive stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'usual clinical treatment', 'description': 'usual treatment in clinic', 'interventionNames': ['Other: as usual care']}], 'interventions': [{'name': 'cognitive stimulation', 'type': 'BEHAVIORAL', 'description': 'video education, board games, and 24-hour dietary recall record', 'armGroupLabels': ['multi domain dietary education as cognitive stimulation']}, {'name': 'as usual care', 'type': 'OTHER', 'description': 'history taking, explain data, and discuss how to control healthy condition', 'armGroupLabels': ['usual clinical treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Yong-Kang Clinic', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Ling-Chun Ou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Kaohsiung Normal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Kaohsiung Normal University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ou Ling-Chun', 'investigatorAffiliation': 'National Kaohsiung Normal University'}}}}