Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-04 @ 8:44 PM
Study NCT ID:
NCT06353035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biodiversity Interventions for Well-Being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The research subjects were not randomized or masked to the intervention and control group, because the control group needs volunteers who have no intention of following the yard management instructions advised to the intervention group.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'associations between environmental factors (vegetation, deadwood, and polypore richness, land cover categories and other yard characteristics), yard management practices, activities at the yard, salivary cytokine levels and bacterial measurements (diversity, and taxonomic and functional features).'}], 'primaryOutcomes': [{'measure': 'Skin Gammaproteobacteria', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Difference on skin gammaproteobacterial diversity between rewilding and control group'}], 'secondaryOutcomes': [{'measure': 'Salivary cytokines', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Interleukin-6 and -10 measured from saliva'}, {'measure': 'Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'It will be analyzed if microbial communities are different between treatments'}, {'measure': 'Difference in observed species richness of skin, saliva and stool microbiota', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'It will be analyzed if microbial communities are different between treatments'}, {'measure': 'Difference in taxonomies of skin, saliva and stool microbiota', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'It will be analyzed if microbial communities are different between treatments'}, {'measure': 'Difference in microbial gene pathways of saliva and stool microbiota', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Will be analyzed with shotgun sequencing if gene pathways are different between treatments'}, {'measure': 'Cortisol levels', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Cortisol levels measured from hair samples'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Lower score on a perceived stress scale among intervention treatment compared to control that indicates lower perceived stress levels among intervention treatment. Minimum 0, maximum 40.'}, {'measure': 'Warwick-Edinburgh Mental Wellbeing Scale', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Higher score on a Warwick-Edinburhg Mental Wellbeing scale among intervention treatment compared to control that indicates better mental well-being among intervention treatment. Minimum 14, maximum 70.'}, {'measure': 'Depression Scale', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Lower score on a Depression scale among intervention treatment compared to control that indicates lower levels of depression symptoms among intervention treatment. Minimum 0, maximum 60.'}, {'measure': 'Nature Relatedness Scale', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Higher score on a Nature Relatedness scale among intervention treatment compared to control that indicates stronger sense of connectedness to nature among intervention treatment. Minimum 6, maximum 30.'}, {'measure': 'Metabolites in urine', 'timeFrame': 'Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year', 'description': 'Metabolites of harmful substances are measured from the urine sample.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Commensal microbiome', 'Salivary cytokines', 'Planetary health', 'Well-being'], 'conditions': ['Microbial Colonization', 'Immune System Diseases', 'Well-Being, Psychological', 'Nature, Human']}, 'descriptionModule': {'briefSummary': 'Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.\n\nIn Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.\n\nThe investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways.', 'detailedDescription': "Our specific aims are:\n\nTo assess if rewilding diversifies health-associated skin microbiota and is associated with salivary cytokine levels, gene pathways, cortisol levels and commensal microbiota.\n\nAssess whether there are patterns in the microbiome associated with the salivary cytokine levels and hair cortisol levels.\n\nAssess whether rewilding affects health and psychological measures, such as Perceived Stress Scale (PSS), Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), Depression Scale (DEPS) and Nature Relatedness Scale (NR6).\n\nThe investigators will recruit approximately 42 (21 study subjects per treatment) subjects living in a detached house or terraced house in urban areas and aged between 18-72.\n\nThe medical exclusion criteria include immunosuppressive medications, immune deficiencies, a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes), cancer diagnosis within the last year or on-going cancer treatment. Other exclusion criteria include incompetency and living outside city area."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Living in a detached or terraced house in urban area\n\nExclusion Criteria:\n\n* Immunosuppressive medications\n* Immune deficiencies\n* a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)\n* cancer diagnosis within the last year or on-going cancer treatment\n* Incompetency\n* Living outside city area."}, 'identificationModule': {'nctId': 'NCT06353035', 'acronym': 'BIWE', 'briefTitle': 'Biodiversity Interventions for Well-Being', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Natural Resources Institute Finland'}, 'officialTitle': 'Biodiversity Interventions for Well-being, Neighborhood Rewilding', 'orgStudyIdInfo': {'id': 'NaturalResourcesIFinland'}, 'secondaryIdInfos': [{'id': '346136', 'type': 'OTHER_GRANT', 'domain': 'Strategic Research Council Finland'}, {'id': '346138', 'type': 'OTHER_GRANT', 'domain': 'Strategic Research Council Finland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rewilding', 'description': 'Private yards of the intervention study subjects will be modified with berry bushes, fruit trees, perennial yard plants, meadow flowers, cultivation boxes, organic mulch materials, decaying deadwood, leaf compost and organic plant growing media with high microbial diversity.', 'interventionNames': ['Other: Rewilding']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "The control group's yards will not be modified. Control group receives inorganic fertilizers, moss remover and ant control insecticide (Myrr®; active ingredient imidacloprid 0.03 % w/w)."}], 'interventions': [{'name': 'Rewilding', 'type': 'OTHER', 'description': 'Private yards of the intervention study subjects will be modified with vegetation and deadwood.', 'armGroupLabels': ['Rewilding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00970', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'facility': 'Natural Resources Institute Finland', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Aki Sinkkonen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Natural Resources Institute Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natural Resources Institute Finland', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}