Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-27 @ 8:52 PM
Study NCT ID:
NCT06822803
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Mean Fruit and Vegetable Intake at 8 Weeks', 'timeFrame': 'From enrollment to the end of interventiont at 8 weeks', 'description': 'Fruit and vegetable intake was measured using the National Cancer Institute\'s Fruit and Vegetable Screener as well as through a 1-item question, "Yesterday, how many servings of fruits and vegetables did you consume?" Higher numbers indicate higher levels of fruit and vegetable intake.'}, {'measure': 'Change from Baseline in the Mean Stress Scores at 8 Weeks', 'timeFrame': 'From enrollment to the end of interventiont at 8 weeks', 'description': "Stress levels was measured using Cohen's Perceived Stress Scale. Higher numbers indicate higher levels of stress."}, {'measure': 'Change from Baseline in the Mean Life Satisfaction Scores at 8 Weeks', 'timeFrame': 'From enrollment to the end of interventiont at 8 weeks', 'description': "Life Satisfaction was measured using Diener's Quality of Life. Higher numbers indicate higher levels of life satisfaction."}, {'measure': 'Change from Baseline in the Mean Body Mass Index Scores at 8 Weeks', 'timeFrame': 'From enrollment to the end of interventiont at 8 weeks', 'description': 'Anthropometrics were collected from all participants using standard techniques. Height was measured barefoot by stadiometer and weight was measured barefoot by a digital scale, with empty pockets and without heavy clothing such as sweaters. Participants will also self-report their height and weight for reference. BMI was calculated using the standard equation using height (cm) and weight (kg) Higher numbers indicate higher BMI.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the Mean Nutrition Knowledge Scores', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'Nutrition knowledge was measured using an adapted version of 20- item Dickson-Spillmann Consumer Oriented Nutrition Knowledge Survey (CoNKS). 10 population relevant True or False style questions were included. Higher numbers indicate higher levels of nutrition knowledge.'}, {'measure': 'Change from Baseline in the Mean Self Efficacy, Outcome Expectation and Reciprocal Determinism', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': "Behavior change was measured through Social Cognitive Theory constructs. These will be measured through Dewar's SCT constructs scales. Higher numbers indicate higher levels of self-efficacy, outcome expectations and reciprocal determinism."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['College student food insecurity', 'Gardening nutrition intervention', 'college students', 'nutrition education', 'social cognitive theory'], 'conditions': ['Food Insecurity', 'Obesity Prevention']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if an urban gardening nutrition education program can have positive health effects on food insecure college students. The main question it aims to answer is to determine whether an 8-week urban-gardening nutrition intervention can improve fruit and vegetable intake, nutrition knowledge, Body Mass Index (BMI) and body fat percentage in college students with food insecurity.\n\nParticipants will:\n\nFill out a questionnaire regarding demographics, food insecurity, fruit and vegetable intake, nutrition knowledge, self-efficacy and health beliefs.\n\nAllow researchers to measure height, weight and body fat percentage Participate in a 1-hour education cooking or gardening session once a week for 8 weeks Receive text message reminders for meeting dates'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be enrolled at FIU\n* Age 18+ years old\n* Literate in English\n* Food insecure\n\nExclusion Criteria:\n\n* Students who are student athletes\n* Women who are pregnant or planning to become pregnant in the next 6 months'}, 'identificationModule': {'nctId': 'NCT06822803', 'acronym': 'UGNIFICS', 'briefTitle': 'Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students', 'organization': {'class': 'OTHER', 'fullName': 'Florida International University'}, 'officialTitle': 'Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students', 'orgStudyIdInfo': {'id': 'IRB-19-0134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gardening Nutrition Education Program', 'description': "Intervention group participants completed in person 1-hour educational sessions, once a week for 6 weeks, and completed the post test and anthropometric measurements on the 7th week. The sessions included nutrition education, recipes, cooking demos, home gardening tips, and a take home vertical garden. A satisfaction survey was also administered at the last educational session (week 6). Multiple weekly sessions were scheduled to accommodate the participants' schedules. Sessions were capped at 12 students to allow for a more personalized experience. Text messages were used weekly to remind the participants and confirm attendance for each session.", 'interventionNames': ['Behavioral: Gardening Nutrition Education Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group did not receive the intervention.'}], 'interventions': [{'name': 'Gardening Nutrition Education Program', 'type': 'BEHAVIORAL', 'description': 'This intervention was a 6-week Social Cognitive Theory based, urban gardening, cooking and nutrition education program designed to change health behavior mediators, fruit and vegetable intake, stress, and life satisfaction in food insecure college students.', 'armGroupLabels': ['Gardening Nutrition Education Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33330', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida International University', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Catherine Coccia, PhD, RD', 'investigatorAffiliation': 'Florida International University'}}}}