Well-beingNCT05486156
Evaluation of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature
A study testing A Time with e-Nature in people with Well-being and Happiness, run by Hospital Israelita Albert Einstein at 6 sites in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being, Happiness
- What is being tested?
- A Time with e-Nature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 6 sitesBrazil
- Study dates
- 8 Oct 2022to 24 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Display walking difficulties;
- Participants with phobia related to elements of nature;
- History of allergies when in contact with nature.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Parque das Neblinas
Bertioga, São Paulo, 11250-000
Reserva Particular de Patrimônio Natural Salto Morato
Guaraqueçaba, Paraná, 83390-000
Parque Natural Municipal Varginha
São Paulo, São Paulo, 04858-570
Instituto Butantan
São Paulo, São Paulo, 05503-900
Parque Natural Municipal Fazenda do Carmo
São Paulo, São Paulo, 08265-060
Parque Estadual da Cantareira
São Paulo, 02377-000
About this study
Official title: Evaluation of the Effectiveness of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature in Different Natural Areas: a Randomized Clinical Trial
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
- Conditions
- Well-being, Happiness
- Being tested
- A Time with e-Nature
- Keywords
- Nature exposure, Multicomponent treatment, Randomized clinical trial, Well-being, Connection with nature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Time with e-NatureOther
Integrated multisensory experience (aesthetic, emotional and knowledge) in two stages:
- Observation of nature through the senses (smell, hearing, sight, touch, taste) and the appreciative look.
- Observation focused on the local avifauna and flora during the trail accompanied by a research biologist from the group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: A Time with e-Nature |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: immediately pre and immediately post intervention and within 4 weeks post intervention
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.
Measured: Immediately Pre intervention and within 4 weeks post intervention
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.
Measured: Immediately Pre intervention and within 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start8 Oct 2022
- Primary completion1 May 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be separated into two groups during the study, the intervention group (IG) and the control group (CG).
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Grupo Boticário de Proteção à Natureza
- Responsible party
- Sponsor
- Investigators
- Eliseth R Leão, PhD, Principal investigator, Hospital Israelita Albert EinsteinRoberta M Savieto, MNP, Study chair, Hospital Israelita Albert EinsteinDenise TN Maki, MD, Study chair, Hospital Israelita Albert EinsteinLetícia B Oliveira, BSN, Study chair, Hospital Israelita Albert EinsteinLuccas GR Longo, MSc, Study chair, São Paulo Municipal Secretary of Green and the EnvironmentLuciano M Lima, MSc, Study chair, Butantan InstituteErika Hingst-Zaher, Phd, Study chair, Butantan InstituteKarina P Patricio, PhD, Study chair, The Medical School (FMB) of São Paulo State University (Unesp),
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486156
- Sponsor's protocol ID
- A time with e-Nature
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39874898
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature in Different Natural Areas: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05486156
- Acronym / sponsor ID
- A time with e-Nature
- Conditions
- Well-being, Happiness
- Keywords
- Nature exposure, Multicomponent treatment, Randomized clinical trial, Well-being, Connection with nature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Fundação Grupo Boticário de Proteção à Natureza
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be separated into two groups during the study, the intervention group (IG) and the control group (CG).
| Arm | Type | Receives |
|---|---|---|
| Intervention A Time with e-Nature Group (Multicomponent Nature-Based Intervention - MNBI) | Experimental | Other: A Time with e-NatureAfter 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. |
| Control Group | Active comparator | Other: A Time with e-NatureThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Display walking difficulties;
- Participants with phobia related to elements of nature;
- History of allergies when in contact with nature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Time with e-NatureIntegrated 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. | Other | Control Group, Intervention A Time with e-Nature Group (Multicomponent Nature-Based Intervention - MNBI) |
Primary outcome
Change from baseline Well-Being Index at 30 days follow-up.
Time frame: immediately pre and immediately post intervention and within 4 weeks post intervention
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.
4 secondary outcomes
Change from baseline self-perception of happiness at immediate post-intervention and 30 days follow-up.
Time frame: 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.
Time frame: immediately pre and immediately post intervention and within 4 weeks post intervention
Change of Connection with Nature from baseline to 30 days post-intervention
Time frame: Immediately Pre intervention and within 4 weeks post intervention
Change from baseline nature engagement at 30 days after intervention
Time frame: Immediately Pre intervention and within 4 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 39874898Leao 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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Model of nature-based health interventions as a complex adaptive system adopted in experimental group (MNBI)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Time with e-Nature in people with Well-being and Happiness, run by Hospital Israelita Albert Einstein at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Well-Being Index at 30 days follow-up. (time frame: immediately pre and immediately post intervention and within 4 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.