Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:48 PM
Study NCT ID:
NCT01102959
Status:
UNKNOWN
Last Update Posted:
2010-04-13
First Post:
2010-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-12-21', 'releaseDate': '2010-11-22'}, {'resetDate': '2011-02-23', 'releaseDate': '2011-01-27'}, {'resetDate': '2011-03-31', 'releaseDate': '2011-03-01'}, {'resetDate': '2011-05-03', 'releaseDate': '2011-04-06'}, {'resetDate': '2011-07-27', 'releaseDate': '2011-06-29'}, {'releaseDate': '2011-09-28', 'unreleaseDateUnknown': True}, {'resetDate': '2011-11-02', 'releaseDate': '2011-09-29'}, {'resetDate': '2012-04-06', 'releaseDate': '2012-03-13'}, {'resetDate': '2012-05-25', 'releaseDate': '2012-04-27'}, {'resetDate': '2012-07-23', 'releaseDate': '2012-06-21'}, {'releaseDate': '2012-08-08', 'unreleaseDateUnknown': True}, {'resetDate': '2025-01-30', 'releaseDate': '2024-12-23'}], 'estimatedResultsFirstSubmitDate': '2010-11-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2010-04-07', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number the answers correct or incorrect on carbohydrate counting in portions of real food', 'timeFrame': '1 month', 'description': "One month after intervention the adolescents' ability in CH counting will be tested.\n\nIn an experimental kitchen, the adolescents will look at portions of real food and will provide answer sheet on carbohydrate counting.\n\nThe answer sheet have 11 questions based on the different food groups, each group will be represented by one type of food.\n\nWe will compare of photographic education material and list of foods equivalent by analysis of the answering sheets.\n\nWe will categorize the answers by correct or incorrect. The statistics analysis we will compare the average score of each group."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['EDUCATION', 'DIABETES MELLITUS', 'ADOLESCENT', 'DIABETIC DIET'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study focuses on obtaining accurate information on the effectiveness of photographic educational material on orientation of carbohydrate counting for adolescents with diabetes.', 'detailedDescription': 'The adolescents with diabetes at the Pediatric Endocrinology and Diabetes outpatient clinic, will be randomly distributed between two groups: those who will receive orientation on carbohydrate counting through photographic educational material and those through a list of foods equivalent.\n\nResearch will follow 3 steps:\n\nFirst, data will be collected on age, gender, BMI, HbA1C, schooling, type of educational material and parents grade level; answer sheets will be applied to evaluate previous knowledge on carbohydrate counting; orientation will be provided on counting with photo material or list.\n\nSecond, after a month of using the educational material, a quiz by phone will be conducted with the sole intent to reinforce orientation.\n\nThird, two days later, adolescents will be directed to the experimental kitchen to see portions of real food and provide answers on amount or choice of carbohydrate.\n\nStatistical tools will be applied to evaluate results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescents with diabetes aged 11 years to 19 years who count carbohydrates in their diet.\n* Adolescents with more than 6 years of study .\n* There is no restriction ethnic, social, gender, nutrition status, type of diabetes.\n\nExclusion Criteria:\n\n* Adolescents with diabetes aged 11 years to 19 years who not count carbohydrate counting in your diet.\n* Adolescents with less than 6 years of study.\n* Adolescents who don't want to participated in this research."}, 'identificationModule': {'nctId': 'NCT01102959', 'briefTitle': 'The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes', 'orgStudyIdInfo': {'id': '1182/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photographic Material', 'description': 'Photographic Educational Material on Carbohydrate Counting', 'interventionNames': ['Device: Photographic Educational Material']}], 'interventions': [{'name': 'Photographic Educational Material', 'type': 'DEVICE', 'otherNames': ['Photo', 'Education', 'Nutrition'], 'description': 'Photographic Educational Material on Carbohydrate Counting', 'armGroupLabels': ['Photographic Material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Alexandre A. Ferraro, PHD', 'role': 'CONTACT', 'email': 'ferraro@usp.br', 'phone': '( 5511) 30698672'}, {'name': 'Adriana S. Gandolfo, Dietitian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of São Paulo General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Adriana S. Gandolfo, Dietitian', 'role': 'CONTACT', 'email': 'adriana.gandolfo@icr.usp.br', 'phone': '( 5511)30698558'}], 'overallOfficials': [{'name': 'Alexandre A. Ferraro, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'University of São Paulo General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sandra Josefina Ferraz Ellero Grisi', 'oldOrganization': 'University of Sao Paulo General Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-11-22', 'type': 'RELEASE'}, {'date': '2010-12-21', 'type': 'RESET'}, {'date': '2011-01-27', 'type': 'RELEASE'}, {'date': '2011-02-23', 'type': 'RESET'}, {'date': '2011-03-01', 'type': 'RELEASE'}, {'date': '2011-03-31', 'type': 'RESET'}, {'date': '2011-04-06', 'type': 'RELEASE'}, {'date': '2011-05-03', 'type': 'RESET'}, {'date': '2011-06-29', 'type': 'RELEASE'}, {'date': '2011-07-27', 'type': 'RESET'}, {'date': '2011-09-28', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2011-09-29', 'type': 'RELEASE'}, {'date': '2011-11-02', 'type': 'RESET'}, {'date': '2012-03-13', 'type': 'RELEASE'}, {'date': '2012-04-06', 'type': 'RESET'}, {'date': '2012-04-27', 'type': 'RELEASE'}, {'date': '2012-05-25', 'type': 'RESET'}, {'date': '2012-06-21', 'type': 'RELEASE'}, {'date': '2012-07-23', 'type': 'RESET'}, {'date': '2012-08-08', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2024-12-23', 'type': 'RELEASE'}, {'date': '2025-01-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alexandre Archanjo Ferraro, Adriana Servilha Gandolfo, University of Sao Paulo General Hospital'}}}}