Nationwide Research on the Rewilding of Kindergarten Yards

NCT06390878 | Recruiting

• 1 other identifier: R24023
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Skin Gammaproteobacteria

  Difference on skin gammaproteobacterial diversity between rewilding and control group

  Baseline, 3 month, 1 year, 2 year, 3 year

Secondary Outcomes (14)

• Cortisol levels

  Baseline, 3 month, 1 year, 2 year, 3 year

• Difference in diversity of skin, saliva and stool microbiota

  Baseline, 3 month, 1 year, 2 year, 3 year

• Microbial observed species richness

  Baseline, 3 month, 1 year, 2 year, 3 year

• Difference in taxonomies of skin, saliva and stool microbiota

  Baseline, 3 month, 1 year, 2 year, 3 year

• White blood cell distribution

  Baseline, 3 month, 1 year, 2 year, 3 year

Other Outcomes (9)

• Associations between environmental factors and cytokine levels.

  Baseline, 3 month, 1 year, 2 year, 3 year

• Associations between environmental factors and commensal microbiota.

  Baseline, 3 month, 1 year, 2 year, 3 year

• Associations between environmental factors and white blood cells

  Baseline, 3 month, 1 year, 2 year, 3 year

Study Arms (2)

Rewilding

EXPERIMENTAL

The kindergarten yards are modified with natural elements to increase children's exposure to biodiversity and playground equipment are incorporated to the yards to increase children's physical activity.

Other: Biodiversity

Control

EXPERIMENTAL

The kindergarten yards are not rewilded with natural elements and the biodiversity is low at the yards. Playground equipment are incorporated to the yards to increase children's physical activity.

Other: Playground equipment

Interventions

Biodiversity OTHER

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

Rewilding

Playground equipment OTHER

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

Control

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Attendance in kindergarten

You may not qualify if:

• Use of antibiotics in the year before sampling

Sponsors & Collaborators

• Natural Resources Institute Finland: lead
• Tampere University: collaborator

Study Sites (2)

Natural Resources Institute Finland

Helsinki, Uusimaa, 00970, Finland

RECRUITING

Tampere University

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Communicable Diseases; Dermatitis, Atopic; Hypersensitivity; Respiratory Tract Infections

Interventions

Biodiversity

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Aki Sinkkonen

  Natural Resources Institute Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanna Hurtola

CONTACT

+358295322500; sanna.hurtola@luke.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

FI (2)