Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-25 @ 12:38 AM
Study NCT ID:
NCT04080960
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dining With Diabetes in Pennsylvania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemoglobin A1C', 'timeFrame': '3 months', 'description': 'participants can choose to have their hemoglobin A1C taken at the first and follow-up class, 3 months later'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '29729134', 'type': 'RESULT', 'citation': "Griffie D, James L, Goetz S, Balotti B, Shr YH, Corbin M, Kelsey TW. Outcomes and Economic Benefits of Penn State Extension's Dining With Diabetes Program. Prev Chronic Dis. 2018 May 3;15:E50. doi: 10.5888/pcd15.170407."}]}, 'descriptionModule': {'briefSummary': "Penn State Extension's Dining with Diabetes program is an evidence-based community education program for people with or at risk for type 2 diabetes. The program teaches participants how to prevent or manage their disease by providing practical knowledge and strategies to make the necessary lifestyle changes that will lead to healthier living and reduction in the risk of complications. The overall goals and objectives of the program are as follows:\n\nIncreasing knowledge of healthy food choices for families with or at risk for diabetes Promoting behavior changes by offering demonstrations and tasting of healthy food.\n\nIncreasing knowledge of essential medical tests associated with diabetes management.\n\nPromoting physical activity as a component of diabetes control. Encouraging self-management and self-efficacy skill. Connecting participants to their healthcare providers for long-term follow-up. The program is designed to meet 4 consecutive weeks and then a 3 month follow-up. Participants A1c and blood pressure are taking at the first and follow-up classes. Classes consist of a nutrition lesson, physical activity, cooking demonstration and food tasting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults residents of Pennsylvania', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with type 2 diabetes individuals with pre-diabetes individuals at risk of developing type 2 diabetes healthy family members/caretakers healthy volunteers\n\nExclusion Criteria:\n\n* under age 18'}, 'identificationModule': {'nctId': 'NCT04080960', 'acronym': 'DWD', 'briefTitle': 'Dining With Diabetes in Pennsylvania', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Dining With Diabetes in Pennsylvania', 'orgStudyIdInfo': {'id': 'PRAMS00036501'}, 'secondaryIdInfos': [{'id': '208113', 'type': 'OTHER_GRANT', 'domain': 'NNLM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lifestyle modification education', 'type': 'BEHAVIORAL', 'description': 'Lifestyle modification education and goal setting'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}