Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 11:04 AM
Study NCT ID:
NCT07220057
Status:
COMPLETED
Last Update Posted:
2025-10-23
First Post:
2025-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustainable Culturally Adapted Nutrition (SCAN) Program
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2025-10-21', 'studyFirstSubmitQcDate': '2025-10-21', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of Diabetes Prevention Program (DPP) sessions attended', 'timeFrame': 'Baseline, at the end of the SCAN intervention (12 months after start of SCAN intervention)'}], 'secondaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': 'Baseline, at the end of the SCAN intervention (12 months after start of SCAN intervention)'}, {'measure': 'Change in calculated Body Mass Index (BMI)', 'timeFrame': 'Baseline, at the end of the SCAN intervention (12 months after start of SCAN intervention)', 'description': 'BMI will be calculated as kg/m2.'}, {'measure': 'Change in HbA1c level', 'timeFrame': 'Baseline, at the end of the SCAN intervention (12 months after start of SCAN intervention)'}, {'measure': 'Low-Density Lipoprotein (LDL) level', 'timeFrame': 'Baseline, at the end of the SCAN intervention (12 months after start of SCAN intervention)'}, {'measure': 'High-Density Lipoprotein (HDL) level', 'timeFrame': 'Baseline, at the end of the SCAN intervention (12 months after start of SCAN intervention)'}, {'measure': 'Triglyceride level', 'timeFrame': 'Baseline, at the end of the SCAN intervention (12 months after start of SCAN intervention)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the impact of an enhanced, food incentive program \\[called the sustainable culturally adapted nutrition (SCAN) program\\], which is integrated with the Diabetes Prevention Program (DPP) and a food prescription framework. The SCAN program aims is to improve participant adherence and the ability to make sustainable behavioral changes to reduce the chances of developing diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the DPP program conducted by First Mile\n* Body Mass Index (BMI) ≥ 18\n* fasting glucose of 100-126 milligrams per deciliter (mg/dL) and/or Hemoglobin A1C (HbA1C) 5.4%-6.5%\n\nExclusion Criteria:\n\n* Withdrawal from the DPP program\n* Participant opts to not specifically participate in the SCAN program'}, 'identificationModule': {'nctId': 'NCT07220057', 'briefTitle': 'Sustainable Culturally Adapted Nutrition (SCAN) Program', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Improving the Health of Americans Through Prevention and Management of Diabetes, Heart Disease and Stroke - Sustainable Culturally Adapted Nutrition (SCAN) Program', 'orgStudyIdInfo': {'id': 'HSC-SPH-21-0180'}, 'secondaryIdInfos': [{'id': 'HHS000353700001', 'type': 'OTHER', 'domain': 'Texas Department of State Health Services'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sustainable Culturally Adapted Nutrition (SCAN) Program plus DPP plus Produce Delivery', 'description': 'Participants will be a part of the Diabetes Prevention Program (DPP), and additionally, as a participant in the the SCAN program, will receive live online instructional video sessions and email links that provide additional training information. Participants will also receive produce delivery.', 'interventionNames': ['Behavioral: Live instructional video sessions', 'Behavioral: Links to educational videos', 'Behavioral: Diabetes Prevention Program (DPP)', 'Behavioral: Produce Delivery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetes Prevention Program (DPP) plus Produce Delivery', 'description': 'Participants will be a part of the Diabetes Prevention Program (DPP) and will also receive produce delivery.', 'interventionNames': ['Behavioral: Diabetes Prevention Program (DPP)', 'Behavioral: Produce Delivery']}], 'interventions': [{'name': 'Live instructional video sessions', 'type': 'BEHAVIORAL', 'description': 'Three instructional live video sessions will be provided to participants via live videoconferencing. The session will describe fundamentals for preparing produce for cooking, healthy approaches to cooking foods, a review of serving sizes, reading labels, and different classes of health foods. The nutrition education is designed to promote healthy dietary patterns for all by empowering participants to navigate healthy eating through the lens of their own food and cultural experiences. By emphasizing culinary techniques over recipes, instructors can inspire adaptability of culturally familiar flavors and ingredients for a diverse range of ethnicities, abilities, and cooking equipment.', 'armGroupLabels': ['Sustainable Culturally Adapted Nutrition (SCAN) Program plus DPP plus Produce Delivery']}, {'name': 'Links to educational videos', 'type': 'BEHAVIORAL', 'description': 'This online information will supplement and reinforce the information presented in the live instructional video sessions.', 'armGroupLabels': ['Sustainable Culturally Adapted Nutrition (SCAN) Program plus DPP plus Produce Delivery']}, {'name': 'Diabetes Prevention Program (DPP)', 'type': 'BEHAVIORAL', 'description': 'The Diabetes Prevention Program (DPP) is a lifestyle change program intended to stop the onset of type 2 diabetes. The program involves Lifestyle Coaches, who help participants make and maintain the lifestyle changes that can help prevent type 2 diabetes. The Lifestyle Coaches share information about diabetes prevention, debunk fitness and health myths, and encourage fitness and healthy eating in regular group sessions. They also work with participants individually on personalized weight loss and exercise goals and action plans, using the group as a source of support and encouragement.', 'armGroupLabels': ['Diabetes Prevention Program (DPP) plus Produce Delivery', 'Sustainable Culturally Adapted Nutrition (SCAN) Program plus DPP plus Produce Delivery']}, {'name': 'Produce Delivery', 'type': 'BEHAVIORAL', 'description': 'The investigators partnered with the Houston Food Bank (HFB) to offer up to 30 pounds of fresh produce twice per month to all DPP participants through a food prescription (Food Rx) program.', 'armGroupLabels': ['Diabetes Prevention Program (DPP) plus Produce Delivery', 'Sustainable Culturally Adapted Nutrition (SCAN) Program plus DPP plus Produce Delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77006', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'William Perkison, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Texas Department of State Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'William B Perkison', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}