Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-03 @ 3:19 PM
Study NCT ID:
NCT05623202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diet quality', 'timeFrame': '3 months', 'description': 'Food Behavior Checklist for Spanish-speaking participants'}], 'secondaryOutcomes': [{'measure': 'Household food security status', 'timeFrame': '6 weeks, 3 months', 'description': 'U.S. Department of Agriculture 18-item Household Food Security Survey Module'}, {'measure': 'Self-efficacy for food security', 'timeFrame': '6 weeks, 3 months', 'description': 'Self-efficacy for food security scale (Martin et al, 2016)'}, {'measure': 'Food resource management knowledge', 'timeFrame': '6 weeks, 3 months', 'description': 'Expanded Food and Nutrition Education Program (EFNEP) food resource management questionnaire'}, {'measure': 'Food resource management knowledge', 'timeFrame': '6 weeks, 3 months', 'description': 'Knowledge of available local food resources (checklist)'}, {'measure': 'Food resource management skills', 'timeFrame': '6 weeks, 3 months', 'description': 'Expanded Food and Nutrition Education Program (EFNEP) food resource management questionnaire'}, {'measure': 'Food resource management skills', 'timeFrame': '6 weeks, 3 months', 'description': 'Use/access of available local food resources (checklist)'}, {'measure': 'Material capital', 'timeFrame': '6 weeks, 3 months', 'description': 'Perceived neighborhood food availability and affordability scale'}, {'measure': 'Human capital', 'timeFrame': '6 weeks, 3 months', 'description': 'Life Orientation Test (optimism subscale)'}, {'measure': 'Social capital', 'timeFrame': '6 weeks, 3 months', 'description': 'Neighborhood cohesion scale'}, {'measure': 'Social capital', 'timeFrame': '6 weeks, 3 months', 'description': 'Family cohesion scale'}, {'measure': 'Cultural capital', 'timeFrame': '6 weeks, 3 months', 'description': 'Familism scale'}, {'measure': 'Cultural capital', 'timeFrame': '6 weeks, 3 months', 'description': 'Simpatia scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition, Healthy', 'Knowledge, Attitudes, Practice', 'Self Efficacy']}, 'descriptionModule': {'briefSummary': 'Despite a large proportion exhibiting cardiovascular disease risk factors and experiencing food insecurity, U.S. Hispanics/Latinos demonstrate low cardiovascular mortality, which may indicate existing capital (e.g., assets) protecting health and diet. The goal of this study is to evaluate the feasibility and short-term efficacy of a pilot intervention aimed at improving diet quality through strengthening food- and diet-related capital and food security among low-income, Hispanic/Latino adults in San Diego, California. The pilot intervention will be integrated into an existing local health or nutrition program serving low-income Hispanic/Latino adults. Participants will be asked to:\n\n* Complete questionnaires before and after the intervention\n* Engage in nutrition education activities\n* Engage in food access-related activities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identified Hispanic/Latino\n* Living full-time in San Diego County with no plan to move in next 3 months\n* At or below 200% of Federal Poverty Line\n\nExclusion Criteria:\n\n* Not Hispanic/Latino\n* Living outside San Diego County\n* Living only part-time in San Diego County\n* Planning to move out of San Diego County in next 3 months\n* \\>200% of Federal Poverty Line'}, 'identificationModule': {'nctId': 'NCT05623202', 'briefTitle': 'Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Pilot Intervention Study for Capacity-oriented Approaches to Food Security, Diet Quality, and Cardiovascular Disease Risk Among Hispanics/Latinos', 'orgStudyIdInfo': {'id': 'HL150406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capacity-oriented behavior-change intervention', 'interventionNames': ['Behavioral: Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults']}], 'interventions': [{'name': 'Multi-level behavior-change intervention to strengthen food- and diet-related capital to promote food security and diet quality among low-income Hispanic/Latino adults', 'type': 'BEHAVIORAL', 'description': 'The behavior-change intervention with low-income Hispanic/Latino adults will mobilize existing sources of human, material, social, and cultural capital at the individual, household, social, and community level, and will include a nutrition education component and a food access component.', 'armGroupLabels': ['Capacity-oriented behavior-change intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amanda C McClain, PhD, MS', 'role': 'CONTACT', 'email': 'amcclain@sdsu.edu', 'phone': '6195947272'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}