Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 8:04 PM
Study NCT ID:
NCT05383859
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2022-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet and Physical Activity Program for Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-09', 'releaseDate': '2025-03-24'}], 'estimatedResultsFirstSubmitDate': '2025-03-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-14', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Diet recommendations (mean)', 'timeFrame': 'Change from Baseline dietary recommendations at 6 months', 'description': 'Compliance with dietary recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 8 questions for dietary adherence. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 8 (best dietary compliance).'}, {'measure': 'Change in Physical activity recommendations (mean)', 'timeFrame': 'Change from Baseline physical activity recommendations at 6 months', 'description': 'Compliance with physical activity recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 4 questions for physical activity recommendations. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 4 (best dietary compliance).\n\nResult: mean number of recommendations followed.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c (Mean percentage)', 'timeFrame': 'Change from Baseline % of HbA1c at 6 months', 'description': '% of HbA1c'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'An individualized educational intervention are going to be developed. Its based on the COM-B model, designed and applied by Primary Care nursing professionals for patients with type 2 diabetes mellitus. Its expected that participants, after a 6 month intervention, face to face and telephone, will improve their adherence to healthy behaviors related to diet and physical activity, their quality of life and the glycosylated hemoglobin figures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be cared for by one of the nurses participating in the research team\n* Ability to complete the questionnaire\n* Sign the informed consent\n* Keep the Primary care health center during till the end of the research'}, 'identificationModule': {'nctId': 'NCT05383859', 'acronym': 'Td2Ast', 'briefTitle': 'Diet and Physical Activity Program for Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2022.014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (IG)', 'description': '1. Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements.\n2. Dietary and/ or physical activity: face to face plus written material\n3. 3 months later: motivational phone call.', 'interventionNames': ['Behavioral: Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group (CG)', 'description': '1. Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements.\n2. Usual care'}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': '1. Dietary and/ or physical activity: face to face plus written material (at baseline)\n2. 3 months later: motivational phone call.', 'armGroupLabels': ['Intervention Group (IG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'University of Oviedo', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'overallOfficials': [{'name': 'Ruben Martin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oviedo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD aren´t be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Servicio de Salud del Principado de Asturias. Área Sanitaria III', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Researcher, PhD', 'investigatorFullName': 'Rubén Martín Payo', 'investigatorAffiliation': 'University of Oviedo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-24', 'type': 'RELEASE'}, {'date': '2025-04-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rubén Martín Payo, Lecturer, Researcher, PhD, University of Oviedo'}}}}