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Evaluation of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature

NCT ID: NCT05486156

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-08

Study Completion Date

2023-06-24

Brief Summary

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Randomized clinical trial to evaluate the efficacy of a multi-component nature-based intervention on clinical outcomes for visitors from different natural areas in Brazil.

Detailed Description

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There is a growing scientific literature that indicates a series of benefits of contact/connection with nature for health and well-being, such as the mental health improvement, hypertension improvement, restoration of attention and memory and immune system improvement. It is already known, among other findings, that contact with nature, even indirectly, through videos and photos, can promote a greater sense of relaxation, decrease stress levels and can promote positive emotions. The adoption of nature-based interventions has been expanded, both for the prevention of chronic health conditions and the promotion of general well-being, as well as for the treatment of physical, mental and social health.

This clinical trial aims to assess the mean change in the World Health Organization well-being index, changes in self-perception of happiness, vitality, connection and engagement with nature in the pre-intervention, post-intervention and 30-day follow-up moments, in the control and intervention groups, in six different natural areas. In the multicomponent intervention, in addition to including walking in nature with attention to the senses, which will be carried out by the control group, the investigators associate other elements of a cognitive-behavioral nature, aiming human and non-human well-being. Therefore, in this health nature-based intervention, activities related to four types of experience are proposed (1- knowledge; 2- aesthetic/emotional; 3- integrated multisensory, 4- active experience). The study hypothesis is that Well-being, happiness and vitality outcomes will be more positive in the intervention group, and the connection with nature and engagement with conservation at 30 days post-intervention will be greater in the intervention group as well, due to adherence to nature-related activities that will be monitored and knowledge offered

Conditions

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Well-being Happiness

Keywords

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Nature exposure Multicomponent treatment Randomized clinical trial Well-being Connection with nature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be separated into two groups during the study, the intervention group (IG) and the control group (CG).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

In this study data analysts were blinded.

Study Groups

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Intervention A Time with e-Nature Group (Multicomponent Nature-Based Intervention - MNBI)

After signing the Free and Informed Consent Term, participants will be directed to a multicomponent intervention based on the experience of aesthetic, emotional and multisensory appreciation, knowledge, environmental education/interpretation and active involvement. At the end of the activity, the participants will fill in the post-intervention questionnaires, which will be applied immediately and 30 days after the intervention.

Group Type EXPERIMENTAL

A Time with e-Nature

Intervention Type OTHER

Integrated multisensory experience (aesthetic, emotional and knowledge) in two stages:

1. Observation of nature through the senses (smell, hearing, sight, touch, taste) and the appreciative look.
2. Observation focused on the local avifauna and flora during the trail accompanied by a research biologist from the group.

Control Group

The group will do an activity made up of contact with nature during a light walk with attention directed to the senses (classical forest bathing). The trail will be accompanied by a guide who will not make any type of intervention other than offering the questionnaires to be filled in at the end of the activity and driving in the section foreseen for the activity.

Group Type ACTIVE_COMPARATOR

A Time with e-Nature

Intervention Type OTHER

Integrated multisensory experience (aesthetic, emotional and knowledge) in two stages:

1. Observation of nature through the senses (smell, hearing, sight, touch, taste) and the appreciative look.
2. Observation focused on the local avifauna and flora during the trail accompanied by a research biologist from the group.

Interventions

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A Time with e-Nature

Integrated multisensory experience (aesthetic, emotional and knowledge) in two stages:

1. Observation of nature through the senses (smell, hearing, sight, touch, taste) and the appreciative look.
2. Observation focused on the local avifauna and flora during the trail accompanied by a research biologist from the group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Voluntary participation;
* Signed in the Informed Consent Form (able to understand and agree to participate in the study)
* Have conditions of digital access to the link of the study questionnaires, which will be provided by the team.

Exclusion Criteria

* Display walking difficulties;
* Participants with phobia related to elements of nature;
* History of allergies when in contact with nature.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação Grupo Boticário de Proteção à Natureza

UNKNOWN

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eliseth R Leão, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Roberta M Savieto, MNP

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Denise TN Maki, MD

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Letícia B Oliveira, BSN

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Luccas GR Longo, MSc

Role: STUDY_CHAIR

São Paulo Municipal Secretary of Green and the Environment

Luciano M Lima, MSc

Role: STUDY_CHAIR

Butantan Institute

Erika Hingst-Zaher, Phd

Role: STUDY_CHAIR

Butantan Institute

Karina P Patricio, PhD

Role: STUDY_CHAIR

The Medical School (FMB) of São Paulo State University (Unesp),

Gustavo Borba, PhD

Role: STUDY_CHAIR

The Federal University of Technology - Paraná

Lital Bass, BSN

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Sabrina Bomfim

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Floriana Bertini, MD

Role: STUDY_CHAIR

Hospital Israelita Albert Einstein

Locations

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Reserva Particular de Patrimônio Natural Salto Morato

Guaraqueçaba, Paraná, Brazil

Site Status

Parque das Neblinas

Bertioga, São Paulo, Brazil

Site Status

Parque Natural Municipal Varginha

São Paulo, São Paulo, Brazil

Site Status

Instituto Butantan

São Paulo, São Paulo, Brazil

Site Status

Parque Natural Municipal Fazenda do Carmo

São Paulo, São Paulo, Brazil

Site Status

Parque Estadual da Cantareira

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Leao ER, Savieto RM, Borba GB, da Silva Victor E, Bomfim SB, Hingst-Zaher E, Lima LM, Longo LGR, de Oliveira LB, Noguchi DT, Oliveira LPG, Moredo RF, Santos CO, Menini A, Bass LM, Patricio KP, Catissi G, Rosa JM, Soldado EBR, Bertini F, de Barros CG, Kiriyama EJ. Efficacy of a multicomponent nature-based intervention on well-being and environmental engagement: A randomized clinical trial. Environ Int. 2025 Feb;196:109286. doi: 10.1016/j.envint.2025.109286. Epub 2025 Jan 19.

Reference Type DERIVED
PMID: 39874898 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://richardlouv.com/

The website features a biography and all the projects of Richard Louv, who is a writer and journalist whose published books have helped launch an international movement to connect children, families and communities to nature.

https://www.derby.ac.uk/research/centres-groups/nature-connectedness-research-group/

Proposal of the Nature Connectedness Research Group, by University of Derby that inspired the project, based on interventions that aim to improve the relationship between the well-being of man and nature.

https://iwun.sites.sheffield.ac.uk/

Proposal that inspired the project, based on how the natural environment can improve the health and well-being of a city's residents. With this, it is possible to bring the public of cities closer to the promotion of their well-being and nature.

https://www.frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1226197/full

Model of nature-based health interventions as a complex adaptive system adopted in experimental group (MNBI)

Other Identifiers

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A time with e-Nature

Identifier Type: -

Identifier Source: org_study_id