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NCT Number: NCT06390683

Biodiversity Interventions for Assisted Living Centers

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 assisted living centers (BIWE 2), microbial biodiversity interventions are performed to increase biodiversity in urban housing units for people with autism spectrum disorder, disabled people and elderly. 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 yards of the housing units 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

Conditions

Nature, Human Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communicable Diseases Disease Attributes Eye Diseases Immune System and Related Disorders Infections Mental Disorders Microbial Colonization Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment Well-Being, Psychological

Age range

18 year–82 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. The investigators will recruit approximately 36 study subjects living in assisted housing units in urban areas and aged between 18-82.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Person lives in assisted living center

Exclusion criteria

  • Immunosuppressive medications
  • Immune deficiencies
  • a disease affecting immune response (colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)
  • cancer diagnosis within the last year or on-going cancer treatment

Treatment and study plan

Rewilding

Other

Yards of the assisted living centers will be modified with berry bushes, fruit trees, perennial yard plants, meadow flowers, cultivation boxes, organic mulch materials, decaying deadwood, leaf compost and organic plant growing media with high microbial diversity.

Primary outcomes

  1. Skin Gammaproteobacteria

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

    Change in skin gammaproteobacterial diversity

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. Skin bacteria

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

    Changes in skin bacteria are analyzed with Illumina 16s rRNA sequencing.

  3. Saliva microbiota

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

    Changes in saliva microbiota are analyzed with shotgun sequencing.

  4. Saliva gene pathways

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

    Changes in salivary gene pathways are analyzed with shotgun sequencing.

  5. Cortisol levels

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

    Cortisol levels measured from hair samples

  6. Perceived Stress Scale

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

    Decrease in perceived stress scale score during the study period that indicates lower perceived stress levels. Minimum 0, maximum 40.

  7. Warwick-Edinburgh Mental Wellbeing Scale

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

    Increase in Warwick-Edinburhg Mental Wellbeing scale score during the study period that indicates better mental well-being. Minimum 14, maximum 70.

  8. Depression Scale

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

    Decrease in depression scale score during the study period that indicates lower levels of depression symptoms. Minimum 0, maximum 70.

  9. Nature Relatedness Scale

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

    Increase in Nature Relatedness scale during the study period that indicates stronger sense of connectedness to nature. Minimum 6, maximum 30.

  10. Changes in nature contacts

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

    Increase in time that study subjects are in contact with nature during the study period.

  11. Infectious diseases

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

    Infectious diseases are recorded with questionnaires.

Other outcomes

  1. Associations between environmental factors and primary and secondary outcomes

    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 and hair cortisol levels, prevalence of infectious diseases, psychological parameters, and microbial 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 - Research in Assisted Living Centers

Acronym: BIWE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2024
Registry last updated
Apr 30, 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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