Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06631105
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2024-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capability Assessment for Diet and Activity (CADA) Model for Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The assessment of relationships between capabilities and health outcomes using the Structural Equation Modeling (SEM) based on the Capability Approach', 'timeFrame': '1 year', 'description': 'The research employs a survey instrument with Likert-scale and open-ended questions, targeting diabetic adults with or without previous hospital admissions in Central Florida. Structural Equation Modeling (SEM) based on the Capability Approach will be used to analyze the data, allowing for the examination of relationships between capabilities (diet, activity, screening, knowledge) and health outcomes. The SEM will help identify the direct and indirect effects of these capabilities on diabetes management, providing insights into potential intervention points for improving health outcomes in this population.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Hospital Admission', 'Hospital'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study investigates the capabilities related to diet, physical activity, screening, and knowledge among diabetic adults with or without a history of hospital admissions in Central Florida. The hypothesis is that enhancing these capabilities, based on the Capability Approach framework, can significantly reduce hospital readmissions and improve diabetes management outcomes.', 'detailedDescription': "Managing diabetes effectively requires a comprehensive understanding of various capabilities, including diet, physical activity, regular screening, and diabetes-related knowledge. For diabetic adults with a history of hospital admissions, these capabilities are critical in preventing readmissions and improving overall health outcomes.\n\nThe objective of this study is to extend the investigation of feasible opportunities for managing diabetes by including measures of screening practices and knowledge alongside diet and physical activity. By employing the Capability Approach, this research aims to provide a comprehensive assessment of how these capabilities interact with individual and environmental factors to affect diabetes management. This approach will enrich existing knowledge by highlighting the interplay between diet, activity, screening, and knowledge, and how these factors collectively impact health outcomes. It will also inform targeted interventions that address both personal and environmental determinants of diabetes management, contributing to more effective public health strategies.\n\nThe study uses a survey instrument to collect data from diabetic adults who have experienced hospital admissions in Central Florida and those who don't. The data will be analyzed using Structural Equation Modeling (SEM) to explore the relationships and potential causal pathways between the capabilities assessed (diet, activity, screening, knowledge) and health outcomes. This approach, grounded in the Capability Approach framework, will help identify how each capability contributes to the management of diabetes and highlight areas for targeted interventions.\n\nThis study is available in English and Spanish."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants must be 18 years of age or older and diagnosed with diabetes to take part in this research study . Participants do not need to have ever been hospitalized to take part in this study. Participants will provide informed consent online and complete the survey online at their convenience. This study is available in English and Spanish.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 18.\n* Persons diagnosed with diabetes\n* Have an email account with access to a reliable internet connection or smartphone\n\nExclusion Criteria:\n\n* Minors , ages under 18\n* Adults not diagnosed with diabetes\n* Adults who are unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT06631105', 'briefTitle': 'Capability Assessment for Diet and Activity (CADA) Model for Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Florida'}, 'officialTitle': 'Capability Assessment for Diet and Activity Model Extended to Include Screening and Knowledge in Diabetic Adults', 'orgStudyIdInfo': {'id': 'STUDY00006976'}}, 'contactsLocationsModule': {'locations': [{'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amoy C Fraser, PhD, CCRP, PMP', 'role': 'CONTACT', 'email': 'Amoy.Fraser@ucf.edu', 'phone': '4072668742'}, {'name': 'Britney-Ann Wray, BS, CTBS', 'role': 'CONTACT', 'email': 'britney-ann.wray@ucf.edu', 'phone': '4072668742'}, {'name': 'Dexter Hadley, M.D., PhD, M.S.E', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chaithanya Renduchintala, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Central Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Amoy Fraser, PhD, CCRP, PMP', 'role': 'CONTACT', 'email': 'Amoy.Fraser@ucf.edu', 'phone': '4072668742'}, {'name': 'Britney-Ann Wray, BS, CTBS', 'role': 'CONTACT', 'email': 'britney-ann.wray@ucf.edu', 'phone': '4072668742'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'AdventHealth', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}