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CompletedNCT05486156Updated Dec 19, 2024

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

An interventional study of A Time with e-Nature in Well-being and Happiness, sponsored by Hospital Israelita Albert Einstein. Completed at 6 sites in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
486
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Well-being
  • Happiness

Keywords

  • Nature exposure
  • Multicomponent treatment
  • Randomized clinical trial
  • Well-being
  • Connection with nature
03

In context

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Display walking difficulties;
  • Participants with phobia related to elements of nature;
  • History of allergies when in contact with nature.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
486 participants (actual)

Study arms

  • Experimental
    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.

    Other: A Time with e-Nature

  • Active comparator
    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.

    Other: A Time with e-Nature

Interventions

  • OtherA 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.

06

What researchers measure

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.

    Time frame: immediately pre and immediately post intervention and within 4 weeks post intervention

Secondary outcomes

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

    A single question about ): "generally feel happy?" with an 11-point response scale (0-10) for providing a reliable and valid measure of well-being for community surveys. It is a numerical scale that varies from and used in various research ranging from 0 (extremely unhappy) to 10 (extremely happy). There is no founder of this scale being used freely as a numerical scale for several variables in which the individual can quantify in some way what is being studied. The score ranges from 0 to 10. The higher the score, the greater the happiness.

    Time frame: immediately pre and immediately post intervention and within 4 weeks post intervention

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

    Subjective Vitality Scale consists of seven items answered on a seven-point scale, ranging from 1 (not at all true) to 7 (completely true). The respondent needs to indicate how true what the item expresses about how he is currently feeling is true.The participant needs to indicate how true what the item expresses about how they are currently feeling is true. The score ranges from 7 to 49. The higher the score, the greater vitality.

    Time frame: immediately pre and immediately post intervention and within 4 weeks post intervention

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

    The Nature Connection Scale (NCS) is used to verify the affective aspect of the person-environment relationship. It is composed of 14 items that are answered on a Likert Scale of points, ranging from 1 (I totally disagree) to 5 (I totally agree). The score ranges from 14 to 70. The higher the score, the greater the connection with nature.

    Time frame: Immediately Pre intervention and within 4 weeks post intervention

  4. Change from baseline nature engagement at 30 days after intervention

    Nature engagement questions was developed by the project researchers themselves, with variables that trace the main motivations of the participants to go to nature, as well as variables related to the population's engagement with nature. In this way, it will be used to assess the frequency, motivation and access to natural areas, as well as the engagement of participants in three dimensions (values, actions taken at home in favor of nature and nature conservation actions).These questions allow to calculate the percentage of engagement for each type of action.The higher the percentage, the higher the engagement.

    Time frame: Immediately Pre intervention and within 4 weeks post intervention

Other outcomes

  1. Perception at the end of nature-based experience

    The participants emit the perception of the experience in a single word.

    Time frame: Immediately Post intervention

07

Study locations

6 sites
  • Reserva Particular de Patrimônio Natural Salto Morato
    Guaraqueçaba, PR 83390-000, Brazil
  • Parque das Neblinas
    Bertioga, SP 11250-000, Brazil
  • Instituto Butantan
    Sao Paulo, SP 05503-900, Brazil
  • Parque Natural Municipal Varginha
    São Paulo, SP 04858-570, Brazil
  • Parque Natural Municipal Fazenda do Carmo
    São Paulo, SP 08265-060, Brazil
  • Parque Estadual da Cantareira
    São Paulo, 02377-000, Brazil
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05486156
Lead sponsor
Hospital Israelita Albert Einstein
Collaborators
Fundação Grupo Boticário de Proteção à Natureza
Responsible party
Sponsor
First posted
Aug 3, 2022
Start date
Oct 8, 2022
Primary completion
May 1, 2023
Completion
Jun 24, 2023
Last update
Dec 19, 2024

Study contacts

Eliseth R Leão, PhD
principal investigator · Hospital Israelita Albert Einstein
Roberta M Savieto, MNP
study chair · Hospital Israelita Albert Einstein
Denise TN Maki, MD
study chair · Hospital Israelita Albert Einstein
Letícia B Oliveira, BSN
study chair · Hospital Israelita Albert Einstein
Luccas GR Longo, MSc
study chair · São Paulo Municipal Secretary of Green and the Environment
Luciano M Lima, MSc
study chair · Butantan Institute
Erika Hingst-Zaher, Phd
study chair · Butantan Institute
Karina P Patricio, PhD
study chair · The Medical School (FMB) of São Paulo State University (Unesp),
Gustavo Borba, PhD
study chair · The Federal University of Technology - Paraná
Lital Bass, BSN
study chair · Hospital Israelita Albert Einstein
Sabrina Bomfim
study chair · Hospital Israelita Albert Einstein
Floriana Bertini, MD
study chair · Hospital Israelita Albert Einstein

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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