Biodiversity Interventions for Assisted Living Centers (BIWE)

April 25, 2024 updated by: Natural Resources Institute Finland

Biodiversity Interventions for Well-Being - Research in 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

36

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 Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00970
        • Natural Resources Institute Finland

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rewilding
Yards of the housing units are rewilded with vegetation, deadwood and plant residuals.
Other: Rewilding
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.

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, 4 year, 5 year
Change in skin gammaproteobacterial diversity
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cytokines
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Interleukin-6 and -10 measured from saliva
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Cortisol levels
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Cortisol levels measured from hair samples
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
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.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Infectious diseases
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Infectious diseases are recorded with questionnaires.
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 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, 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).
Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 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 (Actual)

February 1, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 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

  • HUS/11940/2022

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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