Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 1:21 PM
Study NCT ID:
NCT05773833
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2023-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indigenous Supported Agriculture "Go Healthy"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-15'}], 'estimatedResultsFirstSubmitDate': '2025-12-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diet using Healthy Eating Index scores', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in vegetable and fruit intake using the National Cancer Institute\'s Automated Self-Administered 24-hour Recall (ASA-24) 2022. This self-report instrument generates a "healthy eating index" (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). Continuous values of the overall HEI score will constitute our primary outcome.'}, {'measure': 'Blood pressure (adults only)', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in systolic and diastolic blood pressure'}, {'measure': 'HDL (adults only)', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in HDL levels measured in mg/dL'}, {'measure': 'LDL (adults only)', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in LDL levels measured in mg/dL'}, {'measure': 'Total cholesterol (adults only)', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in total cholesterol levels measured in mg/dL'}, {'measure': 'Glucose (adults only)', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in glucose levels measured in mg/dL'}, {'measure': 'Triglycerides (adults only)', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in triglyceride levels measured in mg/dL'}], 'secondaryOutcomes': [{'measure': 'BMI status using CDC guidelines', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in BMI will be calculated by dividing weight in kilograms by height in meters squared. Using CDC guidelines, adults will be categorized into the following groups based 1) underweight (BMI \\< 18.5); 2) healthy weight (BMI = 18.5-24.9); 3) overweight (BMI = 25.0-29.9); 4) obese (BMI = 30.0-39.9), and 5) morbidly obese (BMI ≥ 40.0). Child BMI will be calculated as a continuous variable using the CDC Child and Teen BMI Calculator.'}, {'measure': 'HbA1c (adults only)', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in HbA1c levels'}, {'measure': "Food insecurity using the United States Department of Agriculture's Household Food Security Survey Module", 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in food insecurity using the Household Food Security Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of household food supply, including psychological and behavioral responses of household members. To compute levels of food security and insecurity, we will total the number of affirmative responses to these items, counting "Often" and "Sometimes" as affirmative. Consistent with USDA guidelines, 0-2 affirmatives indicate food security, and 3 or more affirmatives indicate food insecurity.'}, {'measure': 'Overall health status using the Short Form-36', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in overall health status with answer options of excellent, very good, good, fair, or poor using the Short Form-36.'}, {'measure': 'Skin Carotenoids', 'timeFrame': 'Measured at baseline and immediately post-intervention (16 weeks)', 'description': 'Change in skin carotenoid score using the Veggie Meter instrument (scale ranging from 0 to 800). Higher scores indicate better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Pressure', 'Obesity', 'CBPR', 'American Indian', 'BMI', 'Food Environment', 'Blood Lipids'], 'conditions': ['Diet, Healthy', 'Blood Pressure', 'Overweight or Obesity', 'Food Insecurity', 'Health Status']}, 'descriptionModule': {'briefSummary': "Native Americans (NAs) have limited access to healthy food and a high prevalence of diet-related diseases. This study will implement an agricultural and health education program in which NA residents of Osage Nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking materials. The program's effect on diet and health outcomes and it's cost-effectiveness will be evaluated, and study processes and findings will be broadly disseminated to support tribes in improving diet and health.", 'detailedDescription': 'The study will implement a new community supported agriculture (CSA) program, which the investigators refer to as the "Go Healthy" Indigenous Supported Agriculture (ISA) program, in which citizens in Osage Nation will receive a weekly share of fresh fruits and vegetables for 16 weeks. The investigators will test the efficacy of the "Go Healthy" program combined with culturally-tailored nutrition and cooking education on diet and health outcomes among NA households, evaluate its cost-effectiveness, and develop a multimedia toolkit for disseminating findings.\n\nSpecific Aims:\n\n1. Conduct a randomized controlled trial to test the newly developed ISA program\'s effect on diet, blood pressure, and blood lipids (primary outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), food insecurity, health status, and Skin carotenoid measurement by Veggie Meter (secondary outcomes) among 200 NA households (400 adults and up to 400 children) with an index household adult (aged 18-75) identifying as NA with overweight/obesity;\n2. Perform an economic evaluation for individual (e.g., health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes; and\n3. Document and disseminate study processes and findings using participatory video methods, and compile a web-based toolkit for other NA communities to use to improve tribal food systems'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Adult Participant Inclusion Criteria:\n\n* 18-75 years of age\n* Identify as Native American (index adult participant only)\n* Reside in Osage Nation\n* Plan to stay in Osage Nation in the next year\n* Overweight ot obesity, defined as BMI \\>= 25 kg/m2, measured by research staff (index adult participant only)\n* Willing and able to follow study procedures\n\nChild Participant Inclusion Criteria:\n\n* 3-17 years of age\n* Reside in Osage Nation\n* Plan to stay in Osage Nation in the next year\n* Willing and able to follow study procedures\n\nExclusion Criteria:\n\n* Those that are pregnant or planning to become pregnant during the study period'}, 'identificationModule': {'nctId': 'NCT05773833', 'acronym': 'ISA', 'briefTitle': 'Indigenous Supported Agriculture "Go Healthy"', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University Center for Health Sciences'}, 'officialTitle': 'Osage Community Supported Agriculture', 'orgStudyIdInfo': {'id': '2021026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Go Healthy" Intervention Group', 'description': '"Go Healthy" program', 'interventionNames': ['Behavioral: "Go Healthy" program']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list Control Group', 'description': 'Monetary compensation equal in value to the "Go Healthy" program'}], 'interventions': [{'name': '"Go Healthy" program', 'type': 'BEHAVIORAL', 'description': 'Weekly food boxes of fresh fruits and vegetables for 16 weeks; healthy eating and traditional foods curriculum available inside the box; monthly in-person healthy eating and traditional Indigenous foods cooking workshop; Indigenous cooking demonstration video website links to accompany recipes; and a kitchen starter kit with kitchen cooking supplies', 'armGroupLabels': ['"Go Healthy" Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74056', 'city': 'Pawhuska', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The Osage Nation', 'geoPoint': {'lat': 36.66784, 'lon': -96.33723}}], 'overallOfficials': [{'name': 'Valarie Jernigan, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma State University Center for Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University Center for Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oklahoma', 'class': 'OTHER'}, {'name': 'Osage Nation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}