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Active, Not Recruiting

NCT Number: NCT06353035

Biodiversity Interventions for Well-Being

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.

In 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.

The 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Natural Resources Institute Finland

Helsinki, Uusimaa, 00970, Finland

About this study

Our specific aims are:

To assess if rewilding diversifies health-associated skin microbiota and is associated with salivary cytokine levels, gene pathways, cortisol levels and commensal microbiota.

Assess whether there are patterns in the microbiome associated with the salivary cytokine levels and hair cortisol levels.

Assess 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).

The 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.

The 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Living in a detached or terraced house in urban area

Exclusion criteria

  • 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
  • Incompetency
  • Living outside city area.

Treatment and study plan

Rewilding

Other

Private yards of the intervention study subjects will be modified with vegetation and deadwood.

Primary outcomes

  1. Skin Gammaproteobacteria

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    Difference on skin gammaproteobacterial diversity between rewilding and control group

Secondary outcomes

  1. Salivary cytokines

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    Interleukin-6 and -10 measured from saliva

  2. Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    It will be analyzed if microbial communities are different between treatments

  3. Difference in observed species richness of skin, saliva and stool microbiota

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    It will be analyzed if microbial communities are different between treatments

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

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    It will be analyzed if microbial communities are different between treatments

  5. Difference in microbial gene pathways of saliva and stool microbiota

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    Will be analyzed with shotgun sequencing if gene pathways are different between treatments

  6. Cortisol levels

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    Cortisol levels measured from hair samples

  7. Perceived Stress Scale

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    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.

  8. Warwick-Edinburgh Mental Wellbeing Scale

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    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.

  9. Depression Scale

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    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.

  10. Nature Relatedness Scale

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    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.

  11. Metabolites in urine

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    Metabolites of harmful substances are measured from the urine sample.

Other outcomes

  1. Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being

    Time frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

    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).

Sponsors and collaborators

Lead sponsor

Natural Resources Institute Finland

Other Gov

Collaborators

  • Tampere University

Registry information

Official study title

Biodiversity Interventions for Well-being, Neighborhood Rewilding

Acronym: BIWE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
Apr 8, 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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