Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
Study NCT ID:
NCT04207268
Status:
WITHDRAWN
Last Update Posted:
2022-06-22
First Post:
2019-12-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051639', 'term': 'Gardening'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Protocol could not be initiated due to COVID.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Carotenoids', 'timeFrame': '4 months', 'description': 'The primary outcome is between group differences in total plasma carotenoids from baseline to 16 weeks. Plasma carotenoids are a reliable bio-marker of dietary intake of F\\&V.'}, {'measure': 'Self-reported dietary intake', 'timeFrame': '4 months', 'description': 'Investigators will also test the between group differences in self-reported servings of fruits and vegetables as assessed by 24-hour recalls.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular disease risk score', 'timeFrame': '4 months', 'description': 'Differences in Cardiovascular Disease (CVD) risk score based on the American College of Cardiology/American Heart Association (ACC/AHA) lifetime CVD risk score calculation (risk score range 0-100%). Higher scores indicate greater risk of a lifetime CVD-related event.'}, {'measure': 'Physical activity', 'timeFrame': '4 months', 'description': 'Between group differences in minutes of physical activity as measured by the International Physical Activity Questionnaire (IPAQ), (range in minutes, 0-3000+). Higher scores indicate more physical activity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular disease'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effect of group-based nutrition advice plus gardening (intervention) versus group-based nutrition advice alone on dietary intake of fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD).', 'detailedDescription': 'Study participants will be randomly assigned to attend group sessions related to gardening with nutrition advice or nutrition advice alone. The main goal of the intervention will be to encourage participants to increase their intake of fruits and vegetables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are at least 20 years old\n2. Have transportation and are willing to travel to the Hershey Community Garden\n3. Have any two health conditions or risk factors for CVD. These include, but are not limited to:\n\n 1. Any history of cardiovascular disease\n 2. Any family history of premature cardiovascular disease\n 3. Any history of stroke\n 4. High cholesterol\n 5. High blood pressure\n 6. Overweight/obesity (BMI \\>=25)\n 7. Diabetes\n 8. Current or past Tobacco use\n\nExclusion Criteria:\n\n1. Currently tends a vegetable garden\n2. Moving out of the area in the next 4 months\n3. Non-English speaking\n4. Pregnant women\n5. Participation in a past gardening study\n6. Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)\n7. A medical condition that precludes safe pursuit of gardening, i.e., recent heart conditions (e.g., heart failure, stroke, heart attack), recent or pending surgery, severe orthopedic conditions, pending hip/knee replacement, paralysis, dementia, blindness, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or allergies.\n8. History of difficulty obtaining blood samples or fear of needles'}, 'identificationModule': {'nctId': 'NCT04207268', 'briefTitle': 'Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Dietary Intake of Fruits and Vegetables and Cardiovascular Disease Risk', 'orgStudyIdInfo': {'id': 'STUDY00013976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gardening and Nutrition Advice', 'description': 'Participate in gardening activities, food demonstrations and nutrition advice', 'interventionNames': ['Behavioral: Gardening and Nutrition Advice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nutrition Advice alone', 'description': 'Participate in only nutrition advice', 'interventionNames': ['Behavioral: Nutrition Advice']}], 'interventions': [{'name': 'Gardening and Nutrition Advice', 'type': 'BEHAVIORAL', 'description': 'Participate in gardening activities, gardening instructions and nutrition advice', 'armGroupLabels': ['Gardening and Nutrition Advice']}, {'name': 'Nutrition Advice', 'type': 'BEHAVIORAL', 'description': 'Participate in only nutrition advice', 'armGroupLabels': ['Nutrition Advice alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Susan Veldheer, DEd, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Family and Community Medicine', 'investigatorFullName': 'Susan Veldheer', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}