NCT05492006

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 24, 2026

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

August 5, 2022

Last Update Submit

August 21, 2026

Conditions

Keywords

health promotionhealthy agingnatureimmunologicalolder

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 COMPARATOR

Group 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.

Behavioral: Intentional contact with nature

Group B: indirect contact with nature

ACTIVE COMPARATOR

The 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.

Behavioral: Indirect contact with nature

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.

Also known as: e-NatPOEM
Group B: indirect contact with nature

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.

Also known as: A time with e-Nature
Group A: intentional contact with nature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

  • Eliseth R Leão, PhD

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

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

Locations