Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-05 @ 10:41 PM
Study NCT ID:
NCT03089151
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Denver Garden Environment and Microbiome Study Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-03-17', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fruit and vegetable intake from baseline at 20 weeks', 'timeFrame': 'Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)', 'description': '6 24-hour diet recalls will be collected at random'}, {'measure': 'Change in sedentary time behavior from baseline at 20 weeks', 'timeFrame': '2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)', 'description': 'Accelerometers will be adhered to thigh and collect data for 7 days'}, {'measure': 'Change in bacterial load from baseline at 20 weeks', 'timeFrame': 'Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)', 'description': 'Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples'}, {'measure': 'Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks', 'timeFrame': '2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)', 'description': 'Accelerometers will be adhered to thigh and collect data for 7 days'}, {'measure': 'Change in weight (kg) from baseline at 20 weeks', 'timeFrame': '2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)', 'description': 'Objective measurements of weight will be collected'}, {'measure': 'Change in waist circumference from baseline at 20 weeks', 'timeFrame': '2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)', 'description': 'Objective measurement of waist circumference'}, {'measure': 'Change in pathogenic taxa from baseline at 20 weeks', 'timeFrame': 'Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)', 'description': 'Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples'}, {'measure': 'Change in taxonomic diversity from baseline at 20 weeks', 'timeFrame': 'Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)', 'description': 'Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples'}, {'measure': 'Change in relative dominance from baseline at 20 weeks', 'timeFrame': 'Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)', 'description': 'Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples'}, {'measure': 'Change in indicator taxa from baseline at 20 weeks', 'timeFrame': 'Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)', 'description': 'Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples'}, {'measure': 'Change in Inflammatory biomarkers from baseline at 20 weeks', 'timeFrame': '20 weeks', 'description': 'Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1C from baseline at 20 weeks', 'timeFrame': '20 weeks'}, {'measure': 'Change in blood pressure from baseline at 20 weeks', 'timeFrame': '20 weeks'}, {'measure': 'Change in lipid profile from baseline at 20 weeks', 'timeFrame': '20 weeks', 'description': 'Including LDL, HDL, total cholesterol, triglycerides'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilot Randomized Controlled Trial', 'Community Garden', 'Health Behavior Change', 'Physical Activity', 'Diet', 'Obesity', 'Neighborhood', 'Microbiome', 'Inflammatory biomarkers'], 'conditions': ['Diet Modification', 'Physical Activity', 'Weight Gain', 'Chronic Disease', 'Lifestyle, Sedentary', 'Health Behavior']}, 'descriptionModule': {'briefSummary': 'An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.', 'detailedDescription': 'The pilot study will lead to development of a future, large randomized controlled clinical trial, by fulfilling the following aims:\n\nPilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.\n\nPilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.\n\nPilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.\n\nAim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.\n\nAim 3b: For gardeners and non-gardeners, sample garden soil, gut, skin, and oral microbiome at six time points from April through September to characterize and compare bacterial load, pathogenic taxa, taxonomic diversity, relative dominance, indicator taxa, and metabolomic results.\n\nAim 3c: Demonstrate that gardening reduces inflammatory biomarkers linked to heart disease and cancer, including CRP, IL1b, IL4, IL6, IL10, and TNFa, and that the effect of gardening is mediated by diet, weight gain, physical activity and characteristics of the microbiome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give informed consent in English or Spanish\n* Aged 18 or over\n* Currently on the wait list for a new garden\n* Not have gardened in the past 2 gardening seasons\n\nExclusion Criteria:\n\n* Is not able to complete the study requirements in Spanish or English\n* Aged 17 or younger\n* Has gardened in the past 2 gardening seasons'}, 'identificationModule': {'nctId': 'NCT03089151', 'acronym': 'DGEM', 'briefTitle': 'Denver Garden Environment and Microbiome Study Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart', 'orgStudyIdInfo': {'id': '16-0138, 16-0424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Garden Intervention Group', 'description': 'Participants randomized to the Community Garden Intervention Group will receive the garden intervention. Participants will be assigned a plot for one season and will receive a standard package of services and amenities to support participation in the community garden, including seeds and transplants, tools, new garden classes and access to master community gardeners in Denver.', 'interventionNames': ['Behavioral: Community Garden Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Control Group', 'description': 'The non-gardening group will remain on the DUG wait lists and will not receive the garden intervention.'}], 'interventions': [{'name': 'Community Garden Intervention', 'type': 'BEHAVIORAL', 'description': 'The investigators will recruit 30 prospective gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. DUG randomly assigns people on each garden wait list to available plots, using a lottery. This creates a natural randomized experiment. Participants randomized to the garden intervention will receive a standardized garden resource package, which includes the following:\n\n1. A garden plot in a Denver Urban Garden\n2. Seeds and plant starts\n3. Introductory gardening workshop\n4. Social events including garden-specific events and garden mentoring.\n\nThe non-gardening group will remain on the DUG wait lists and will not receive these resources.\n\nDuration of the intervention is 1 year.', 'armGroupLabels': ['Community Garden Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'overallOfficials': [{'name': 'Jill S Litt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Boulder'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Environmental Studies', 'investigatorFullName': 'Jill Litt', 'investigatorAffiliation': 'University of Colorado, Boulder'}}}}