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NCT Number: NCT06390878

Nationwide Research on the Rewilding of Kindergarten Yards

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).

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Key information

Conditions

Microbial Colonization Allergy Asthma in Children Atopic Dermatitis Cognitive Change Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Disease Attributes Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nature, Human Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Infection Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Natural Resources Institute Finland, Helsinki, Uusimaa, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Attendance in kindergarten

Exclusion criteria

  • Use of antibiotics in the year before sampling

Treatment and study plan

Biodiversity

Other

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

Playground equipment

Other

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

Primary outcomes

  1. Skin Gammaproteobacteria

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Difference on skin gammaproteobacterial diversity between rewilding and control group

Secondary outcomes

  1. Cortisol levels

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Cortisol levels measured from hair samples

  2. Difference in diversity of skin, saliva and stool microbiota

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if microbial communities are different between treatments

  3. Microbial observed species richness

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Higher score in observed species richness of commensal microbiota among biodiversity treatment

  4. Difference in taxonomies of skin, saliva and stool microbiota

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if microbial communities are different between treatments

  5. White blood cell distribution

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if the distribution is different between treatments

  6. White blood cell transcriptomics

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    White blood cell transcriptome is analyzed with single cell RNA sequencing.

  7. Plasma cytokines

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Cytokines will be analyzed analyzed with Meso Scale.

  8. Skin cytokines

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Cytokines will be analyzed using skin tape strip samples.

  9. Infectious diseases

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Infections will be recorded with questionnaires.

  10. Asthma symptoms

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Asthma symptoms will be recorded with questionnaires.

  11. Atopic dermatitis

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Atopic dermatitis will be recorded with questionnaires.

  12. Allergy

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Allergies will be recorded with questionnaires.

  13. Patient-oriented Eczema Measure

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Lower score on patient-oriented Eczema Measure among intervention treatment compared to control that indicates lower eczema among intervention treatment. Minimum 0, maximum 28.

  14. Wechsler Preschool and Primary Scale of Intelligence

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    Higher 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.

Other outcomes

  1. Associations between environmental factors and cytokine levels.

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with cytokine levels.

  2. Associations between environmental factors and commensal microbiota.

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with richness of commensal microbiota.

  3. Associations between environmental factors and white blood cells

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with white blood cell distributions.

  4. Associations between environmental factors and cortisol levels

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with cortisol levels.

  5. Associations between environmental factors and cognitive skills.

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with cognitive skills.

  6. Associations between environmental factors and infectious diseases.

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with the prevalence of infectious diseases.

  7. Associations between environmental factors and atopy.

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with the atopic dermatitis

  8. Associations between environmental factors and allergies.

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with the allergy symptoms.

  9. Associations between environmental factors and asthma.

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year

    It will be analyzed if environmental factors correlate with the asthma symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Sanna Hurtola

CONTACT

[email protected]

+358295322500

Sponsors and collaborators

Lead sponsor

Natural Resources Institute Finland

Other Gov

Collaborators

  • Tampere University

Registry information

Official study title

Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu

Acronym: Vahvistu

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2024
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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