Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT03477305
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BerryCare: A Community Engagement Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in consumption of blackberries', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'Blackberry consumption will be measured in participants during pre screening and throughout the course of the study.'}], 'secondaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on blood pressure will be assessed at baseline and throughout the study.'}, {'measure': 'Change in total cholesterol', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on total cholesterol will be assessed at baseline and throughout the study.'}, {'measure': 'Change in HDL cholesterol', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on HDL cholesterol will be assessed at baseline and throughout the study.'}, {'measure': 'Change in LDL cholesterol', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on LDL cholesterol will be assessed at baseline and throughout the study.'}, {'measure': 'Change in A1c', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on A1c will be assessed at baseline and throughout the study.'}, {'measure': 'Change in carotenoids', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on carotenoid status will be assessed at baseline and throughout the study.'}, {'measure': 'Change in weight', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on weight will be assessed at baseline and throughout the study.'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on waist circumference will be assessed at baseline and throughout the study.'}, {'measure': 'Change in knowledge', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on knowledge of phytonutrients and recommended servings of fruits and vegetables will be assessed at baseline and throughout the study.'}, {'measure': 'Change in self-reported fruit and vegetable intake', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on self-reported fruit and vegetable intake will be assessed at baseline and throughout the study.'}, {'measure': 'Change in group cohesion', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on group cohesion will be assessed at baseline and throughout the study.'}, {'measure': 'Change in physical function', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'The effect of blackberry consumption on physical function will be assessed at baseline and throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['older adults', 'community gardening', 'cooperative extension'], 'conditions': ['Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': 'BerryCare teaches people about the health benefits of blackberries, how to harvest and maintain blackberry bushes and then assesses changes in knowledge and behaviors associated with blackberries and physical measurements.', 'detailedDescription': 'BerryCare seeks to teach community members how to grow thornless, erect blackberry brambles and to healthily consume fresh blackberries using Plate It Up Kentucky Proud recipes. Horticulture, nutrition, and extension experts are working together to design a blackberry-growing program that engages citizens and their community in each step of the process, from planting to harvesting berries. The lessons will be delivered by experts in their respective field, with accompanying extension publications and supplemental materials provided for replication of the curriculum in other counties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Physically incapacitated\n* Mentally incapacitated'}, 'identificationModule': {'nctId': 'NCT03477305', 'briefTitle': 'BerryCare: A Community Engagement Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'BerryCare: A Blackberry Extension Lesson Series to Facilitate Community Engagement and Phytonutrient Intake', 'orgStudyIdInfo': {'id': '43452'}, 'secondaryIdInfos': [{'id': 'P42ES007380', 'link': 'https://reporter.nih.gov/quickSearch/P42ES007380', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BerryCare Participants', 'description': 'Subjects will be recruited to participate in a community gardening program where they will learn the benefits of both physical active gardening and consuming homegrown foods through blackberry consumption.', 'interventionNames': ['Behavioral: Blackberry Consumption']}], 'interventions': [{'name': 'Blackberry Consumption', 'type': 'BEHAVIORAL', 'description': 'Measures of biomedical and behavioral changes resulting from the consumption of blackberries.', 'armGroupLabels': ['BerryCare Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40913', 'city': 'Beverly', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Red Bird Mission', 'geoPoint': {'lat': 36.75671, 'lon': -87.52557}}, {'zip': '40831', 'city': 'Harlan', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Harlan County Extension Office', 'geoPoint': {'lat': 36.84314, 'lon': -83.32185}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40356', 'city': 'Nicholasville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Jessamine County Senior Citizens Center', 'geoPoint': {'lat': 37.88063, 'lon': -84.573}}, {'zip': '41858', 'city': 'Whitesburg', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cowan Community Center', 'geoPoint': {'lat': 37.11843, 'lon': -82.82683}}], 'overallOfficials': [{'name': 'Dawn Brewer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dawn Brewer', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dawn Brewer', 'investigatorAffiliation': 'University of Kentucky'}}}}