Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature
1 other identifier
interventional
54
1 country
1
Brief Summary
Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
June 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedAugust 24, 2026
March 1, 2025
5 months
August 5, 2022
August 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline Concentration of Cytokines in Soluble Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Quantify the change from baseline pre intervention in concentration of cytokines in plasma ng/ml (IFN-γ, IL-10, Granzyme A, IL-13, Granzyme B, IL-2, IL-4, IL-6, TNF-α e perforina) in comparison the concentrations between the periods of 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention
Change from baseline of Cellular Immune Profile at 30 minutes post intervention, within 48-72 hours post intervention and within 25-25 days post intervention
Quantify the changes from baseline pre intervention of frequency of cellular immune populations and their inhibiting, activating, effector and lytic molecules of subpopulation of lymphocytes and NK cells and their memory status in the blood within the period of 30 minutes post intervention, 48-72 hours and 25-35 days post intervention.
immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Secondary Outcomes (1)
Change from baseline affective states at 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
immediately pre intervention, 30 minutes post intervention, within 48-72 hours post intervention and within 25-35 days post intervention.
Study Arms (2)
Group A: intentional contact with nature
ACTIVE COMPARATORGroup A volunteers will take a light walk along the park with green space in a single 1-hour session guided by a Multicomponent Nature-Based Intervention grounded in the "A time with e-Nature" model. This intervention was developed by this same research group and integrates multisensory, aesthetic-emotional, cognitive, and active-engagement dimensions, constituting a structured and replicable protocol.
Group B: indirect contact with nature
ACTIVE COMPARATORThe members of Group B will watch a video with the images of the e-Nature Positive Emotions Photography Database (e-NatPOEM), a database of nature images validated by this same research group for its capacity to evoke positive emotions in a controlled manner. Participants will watch the material in a controlled environment, lasting approximately 45 minutes.
Interventions
The participants will watch a video with validated images of nature from e-Nature Positive Emotions Photography Database (e-NatPOEM). Participants will watch the material in a controlled environment, lasting approximately 45 minutes.
The participants will take a light walk in a park with green spaces guided by research team in a single 1-hour session, based on the Multicomponent Nature-Based Intervention named A time with e-Nature. This intervention integrates multisensory, aesthetic-emotional, cognitive, and active-engagement dimensions.
Eligibility Criteria
You may qualify if:
- individuals of both sexes
- capable of physical and mental to carry out the proposed activities
- capable of mental to fill in the questionnaires.
You may not qualify if:
- autoimmune diseases
- chronic or acute inflammatory diseases
- disease that affects the response of the immune system
- neuromuscular problems
- oncological diseases and neoplastic
- individuals being treated with immunosuppressive drugs or that affect the immune system
- individuals who are under the influence of alcohol or other substances that interfere with cognitive ability
- those who have had contact intentional relationship with nature in the 30-day period prior to participating in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652000, Brazil
Related Publications (1)
Dal Fabbro D, Catissi G, Borba G, Lima L, Hingst-Zaher E, Rosa J, Victor E, Bernardes L, Souza T, Leao E. e-Nature Positive Emotions Photography Database (e-NatPOEM): affectively rated nature images promoting positive emotions. Sci Rep. 2021 Jun 3;11(1):11696. doi: 10.1038/s41598-021-91013-9.
PMID: 34083616BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Eliseth R Leão, PhD
Hospital Israelita Albert Einstein
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 8, 2022
Study Start
June 20, 2023
Primary Completion
November 30, 2023
Study Completion
June 30, 2025
Last Updated
August 24, 2026
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share