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

NCT05486156 | Completed DMC

• 1 other identifier: A time with e-Nature
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Well-being; Happiness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline Well-Being Index at 30 days follow-up.

  The World Health Organization-5 Well-Being Index is a brief scale, composed of five questions in which the participants indicate in each one of them, based on the last two weeks, the frequency of their sensations, being 0 (at no time) and 5 (all of the time). The result is given as the sum of the numbers of each statement, with values ranging from 0, which represents the worst possible quality of life and 25, which is associated with the best possible quality of life.

  immediately pre and immediately post intervention and within 4 weeks post intervention

Secondary Outcomes (4)

• Change from baseline self-perception of happiness at immediate post-intervention and 30 days follow-up.

  immediately pre and immediately post intervention and within 4 weeks post intervention

• Change from baseline vitality at immediate post-intervention and 30 days follow-up.

  immediately pre and immediately post intervention and within 4 weeks post intervention

• Change of Connection with Nature from baseline to 30 days post-intervention

  Immediately Pre intervention and within 4 weeks post intervention

• Change from baseline nature engagement at 30 days after intervention

  Immediately Pre intervention and within 4 weeks post intervention

Other Outcomes (1)

• Perception at the end of nature-based experience

  Immediately Post intervention

Study Arms (2)

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

EXPERIMENTAL

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.

Other: A Time with e-Nature

Control Group

ACTIVE COMPARATOR

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.

Other: A Time with e-Nature

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Display walking difficulties;
• Participants with phobia related to elements of nature;
• History of allergies when in contact with nature.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação Grupo Boticário de Proteção à Natureza: collaborator

Study Sites (6)

Reserva Particular de Patrimônio Natural Salto Morato

Guaraqueçaba, Paraná, 83390-000, Brazil

Location

Parque das Neblinas

Bertioga, São Paulo, 11250-000, Brazil

Location

Parque Natural Municipal Varginha

São Paulo, São Paulo, 04858-570, Brazil

Location

Instituto Butantan

São Paulo, São Paulo, 05503-900, Brazil

Location

Parque Natural Municipal Fazenda do Carmo

São Paulo, São Paulo, 08265-060, Brazil

Location

Parque Estadual da Cantareira

São Paulo, 02377-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 39874898 DERIVED

Related Links

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

Study Officials

• Eliseth R Leão, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Roberta M Savieto, MNP

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Denise TN Maki, MD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Letícia B Oliveira, BSN

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Luccas GR Longo, MSc

  São Paulo Municipal Secretary of Green and the Environment

  STUDY CHAIR

• Luciano M Lima, MSc

  Butantan Institute

  STUDY CHAIR

• Erika Hingst-Zaher, Phd

  Butantan Institute

  STUDY CHAIR

• Karina P Patricio, PhD

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

  STUDY CHAIR

• Gustavo Borba, PhD

  The Federal University of Technology - Paraná

  STUDY CHAIR

• Lital Bass, BSN

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Sabrina Bomfim

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Floriana Bertini, MD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this study data analysts were blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be separated into two groups during the study, the intervention group (IG) and the control group (CG).

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 3, 2022
• Study Start: October 8, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 24, 2023
• Last Updated: December 19, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (6)