Nationwide Research on the Rewilding of Kindergarten Yards (Vahvistu)

April 25, 2024 updated by: Natural Resources Institute Finland

Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Tampere, Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00970
        • Recruiting
        • Natural Resources Institute Finland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Attendance in kindergarten

Exclusion Criteria:

  • Use of antibiotics in the year before sampling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rewilding
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.
Biological: Biodiversity
In rewilding kindergartens, the yards are modified with biological elements, i.e., vegetation and plantation will be added to the yards.
Experimental: Control
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
Playground equipment that increase the physical activity of children will be added to the kindergarten yards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Gammaproteobacteria
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Difference on skin gammaproteobacterial diversity between rewilding and control group
Baseline, 3 month, 1 year, 2 year, 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol levels
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Cortisol levels measured from hair samples
Baseline, 3 month, 1 year, 2 year, 3 year
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
Baseline, 3 month, 1 year, 2 year, 3 year
Difference in observed species richness 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
Baseline, 3 month, 1 year, 2 year, 3 year
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
Baseline, 3 month, 1 year, 2 year, 3 year
Distribution of white blood cells
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
It will be analyzed if the distribution is different between treatments
Baseline, 3 month, 1 year, 2 year, 3 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year
Plasma cytokines
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Cytokines will be analyzed analyzed with Meso Scale.
Baseline, 3 month, 1 year, 2 year, 3 year
Skin cytokines
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Cytokines will be analyzed using skin tape strip samples.
Baseline, 3 month, 1 year, 2 year, 3 year
Infectious diseases
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Infections will be recorded with questionnaires.
Baseline, 3 month, 1 year, 2 year, 3 year
Asthma symptoms
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Asthma symptoms will be recorded with questionnaires.
Baseline, 3 month, 1 year, 2 year, 3 year
Atopic dermatitis
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Atopic dermatitis will be recorded with questionnaires.
Baseline, 3 month, 1 year, 2 year, 3 year
Allergy
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Allergies will be recorded with questionnaires.
Baseline, 3 month, 1 year, 2 year, 3 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associations between environmental factors and primary and secondary outcomes.
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Associations between environmental factors (vegetation, deadwood, and polypore richness, land cover categories and other yard characteristics) and cytokine levels, microbial measurements, white blood cell transcriptome and distribution, cortisol levels, cognitive skills, the prevalence of infectious diseases and atopy, allergy and asthma symptoms.
Baseline, 3 month, 1 year, 2 year, 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Resources Institute Finland

Collaborators

Tampere University

Investigators

  • Principal Investigator: Aki Sinkkonen, Natural Resources Institute Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R24023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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