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Nationwide Research on the Rewilding of Kindergarten Yards

Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06390878
Acronym
Vahvistu
Enrollment
320
Registered
2024-04-30
Start date
2024-05-15
Completion date
2027-08-30
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Asthma in Children, Atopic Dermatitis, Cognitive Change, Microbial Colonization, Nature, Human, Respiratory Infection

Keywords

Commensal microbiome, Atopy, Planetary health, Biodiversity, Cognitive skills

Brief summary

Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities that is associated with altered commensal microbiota and a rising burden of immunological disorders among urban children. The investigators will estimate how rewilding of kindergarten yards affects commensal microbiome, prevalence of allergies, asthma, atopic dermatitis and infections, cortisol levels, cognitive skills and plasma cytokine levels of children. Our specific aims are: To assess if rewilding diversifies health-associated skin, saliva and gut microbiota and reduces infectious diseases and atopic or allergic symptoms. Assess whether the rewilding has positive effects on cognitive skills. Assess whether the rewilding changes cortisol and plasma cytokine levels. The investigators will recruit altogether 320 (160 per treatment) study subjects aged between 1-5 to questionnaire study (Task 2), from which 120 study subjects will be analyzed more detailed using microbiological and blood samples (Task 1).

Interventions

OTHERBiodiversity

In rewilding kindergartens, the yards are modified with biological elements, i.e., vegetation and plantation will be added to the yards.

OTHERPlayground equipment

Playground equipment that increase the physical activity of children will be added to the kindergarten yards.

Sponsors

Tampere University
CollaboratorOTHER
Natural Resources Institute Finland
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Attendance in kindergarten

Exclusion criteria

* Use of antibiotics in the year before sampling

Design outcomes

Primary

MeasureTime frameDescription
Skin GammaproteobacteriaBaseline, 3 month, 1 year, 2 year, 3 yearDifference on skin gammaproteobacterial diversity between rewilding and control group

Secondary

MeasureTime frameDescription
Difference in taxonomies of skin, saliva and stool microbiotaBaseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if microbial communities are different between treatments
White blood cell transcriptomicsBaseline, 3 month, 1 year, 2 year, 3 yearWhite blood cell transcriptome is analyzed with single cell RNA sequencing.
Plasma cytokinesBaseline, 3 month, 1 year, 2 year, 3 yearCytokines will be analyzed analyzed with Meso Scale.
Skin cytokinesBaseline, 3 month, 1 year, 2 year, 3 yearCytokines will be analyzed using skin tape strip samples.
Infectious diseasesBaseline, 3 month, 1 year, 2 year, 3 yearInfections will be recorded with questionnaires.
Asthma symptomsBaseline, 3 month, 1 year, 2 year, 3 yearAsthma symptoms will be recorded with questionnaires.
Atopic dermatitisBaseline, 3 month, 1 year, 2 year, 3 yearAtopic dermatitis will be recorded with questionnaires.
AllergyBaseline, 3 month, 1 year, 2 year, 3 yearAllergies will be recorded with questionnaires.
Patient-oriented Eczema MeasureBaseline, 3 month, 1 year, 2 year, 3 yearLower score on patient-oriented Eczema Measure among intervention treatment compared to control that indicates lower eczema among intervention treatment. Minimum 0, maximum 28.
Wechsler Preschool and Primary Scale of IntelligenceBaseline, 3 month, 1 year, 2 year, 3 yearHigher score on Wechsler Preschool and Primary Scale of Intelligence among intervention treatment compared to control that indicates better cognitive skills among intervention treatment. Minimum 40, maximum 170.
Cortisol levelsBaseline, 3 month, 1 year, 2 year, 3 yearCortisol levels measured from hair samples
Difference in diversity of skin, saliva and stool microbiotaBaseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if microbial communities are different between treatments
Microbial observed species richnessBaseline, 3 month, 1 year, 2 year, 3 yearHigher score in observed species richness of commensal microbiota among biodiversity treatment
White blood cell distributionBaseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if the distribution is different between treatments

Other

MeasureTime frameDescription
Associations between environmental factors and white blood cellsBaseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with white blood cell distributions.
Associations between environmental factors and cortisol levelsBaseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with cortisol levels.
Associations between environmental factors and cognitive skills.Baseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with cognitive skills.
Associations between environmental factors and infectious diseases.Baseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with the prevalence of infectious diseases.
Associations between environmental factors and atopy.Baseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with the atopic dermatitis
Associations between environmental factors and allergies.Baseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with the allergy symptoms.
Associations between environmental factors and asthma.Baseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with the asthma symptoms.
Associations between environmental factors and commensal microbiota.Baseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with richness of commensal microbiota.
Associations between environmental factors and cytokine levels.Baseline, 3 month, 1 year, 2 year, 3 yearIt will be analyzed if environmental factors correlate with cytokine levels.

Countries

Finland

Contacts

Primary ContactSanna Hurtola
sanna.hurtola@luke.fi+358295322500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026