Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-11 @ 3:19 PM
Study NCT ID:
NCT03251950
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2017-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Resource Equity and Sustainability for Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072001', 'term': 'Diet, Healthy'}, {'id': 'D051639', 'term': 'Gardening'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000080802', 'term': 'Horticulture'}, {'id': 'D000383', 'term': 'Agriculture'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2017-08-14', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vegetable and fruit intake among children aged 3-5', 'timeFrame': 'Measured before and after the 15 week intervention', 'description': 'Targeted quarter cup increase in vegetable and fruit intake per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vegetable and fruit intake'], 'conditions': ['BMI', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '37181935', 'type': 'DERIVED', 'citation': 'Patel D, Sisson SB, Sleet K, Rickman R, Love C, Taniguchi T, Sisk M, Jernigan VBB. Changes in Meal and Menu Quality at Early Care and Education Programs after Training with Food Service Staff: the FRESH Study. Curr Dev Nutr. 2023 Feb 20;7(3):100040. doi: 10.1016/j.cdnut.2023.100040. eCollection 2023 Mar.'}, {'pmid': '32258996', 'type': 'DERIVED', 'citation': 'Sleet K, Sisson SB, Dev DA, Love C, Williams MB, Hoffman LA, Jernigan VBB. The Impact of Responsive Feeding Practice Training on Teacher Feeding Behaviors in Tribal Early Care and Education: The Food Resource Equity and Sustainability for Health (FRESH) Study. Curr Dev Nutr. 2019 Sep 20;4(Suppl 1):23-32. doi: 10.1093/cdn/nzz105. eCollection 2020 Jan.'}, {'pmid': '32258995', 'type': 'DERIVED', 'citation': 'Sisson SB, Sleet K, Rickman R, Love C, Bledsoe A, Williams M, Jernigan VBB. Impact of the 2017 Child and Adult Care Food Program Meal Pattern Requirement Change on Menu Quality in Tribal Early Care Environments: The Food Resource Equity and Sustainability for Health Study. Curr Dev Nutr. 2019 Aug 29;4(Suppl 1):12-22. doi: 10.1093/cdn/nzz094. eCollection 2020 Jan.'}]}, 'descriptionModule': {'briefSummary': 'Food insecurity increases the risk of obesity, diabetes, hypertension, and cancer. American Indians (AIs) in Oklahoma are three times as likely as Whites to be food-insecure (21% vs. 7%) and have burdens of obesity (42%), hypertension (38%), and diabetes (15%) that exceed those of the general US population. While individual-level obesity prevention efforts have been implemented with AIs, few environmental interventions to reduce food insecurity and improve fruit and vegetable intake have been conducted with tribal communities. Community gardening interventions have been shown to increase vegetable and fruit intake, reduce food insecurity, and lower BMI among children and adults; however, to date, no such interventions have been evaluated with AI families. The proposed study, entitled "Food Equity Resource and Sustainability for Health (FRESH)," will assess the impact of a tribally-initiated community gardening intervention on vegetable and fruit intake, food insecurity, BMI, and blood pressure in families living on the Osage Nation reservation in Oklahoma.', 'detailedDescription': "The intervention will take place in the inaugural year of Osage Nation's Bird Creek Farm and Community Gardens, where 120 garden plots will be allocated to participating reservation families. The study is guided by the principles of community-based participatory research (CBPR) and the Indigenous food sovereignty movement, which seeks to revitalize seasonal growing and gathering practices and reverse the tide of unhealthy eating caused by the historical loss of tribal lands.\n\nAims and Methods: Led by an AI (Choctaw) Investigator, the study will:\n\nAim #1: Characterize the Osage Nation reservation's food environment by using both objective and perceived measures, and then examine the relationships between these measures and intake of vegetables and fruits, food insecurity, BMI, hypertension, and diabetes.\n\nAim #2: Develop a culturally relevant community gardening intervention and conduct a randomized controlled trial (RCT) to evaluate its efficacy in increasing vegetable and fruit intake and reducing food insecurity, BMI, and blood pressure among Osage families.\n\nAim #3: Create and disseminate a Web- based multimedia manual and documentary film, and evaluate their effectiveness in increasing tribal readiness and capacity to improve local food environments.\n\nInnovation: The proposed study will be the first RCT ever conducted of a community gardening intervention, as well as the first community gardening intervention with AI families. The study will also be one of the first environmental interventions o simultaneously address healthy food production, access, preference, and intake among AIs.\n\nSignificance and Impact: The community gardening intervention will be developed as part of a larger Osage Nation initiative on food security and food sovereignty and as such, is likely to be sustainable if it proves effective. Research findings and products will be disseminated to AI/AN communities nationwide and will help to identify environmental strategies that will improve tribal food environments and the health and quality of life of AI families."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Indian Children aged 3-5 who attend one of the Osage Nation Early Childhood Programs\n* Parents of American Indian children who are aged 18 years and older and whose children are enrolled in Osage Nation Early Childhood Programs\n\nExclusion Criteria:\n\n* Anyone not meeting the aforementioned inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03251950', 'acronym': 'FRESH', 'briefTitle': 'Food Resource Equity and Sustainability for Health', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University Center for Health Sciences'}, 'officialTitle': 'Food Resource Equity and Sustainability for Health', 'orgStudyIdInfo': {'id': 'R01MD011266', 'link': 'https://reporter.nih.gov/quickSearch/R01MD011266', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MD011266', 'link': 'https://reporter.nih.gov/quickSearch/R01MD011266', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '15 week healthy eating and gardening curriculum to be implemented in Osage Nation Early Childhood Programs; 15 week healthy eating parenting curriculum to be implemented online to parents of enrolled children', 'interventionNames': ['Behavioral: healthy eating and gardening']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Wait list control -- to receive intervention after serving as wait list group', 'interventionNames': ['Behavioral: healthy eating and gardening']}], 'interventions': [{'name': 'healthy eating and gardening', 'type': 'BEHAVIORAL', 'description': '15 week healthy eating and gardening intervention for children aged 3-5 years; 15 week online parenting intervention to promote healthy eating; Menu change in early childhood center to promote healthy eating', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74106', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State Univeristy Center for Health Sciences', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Valarie BB 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': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}