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

Well-being Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486156
• Other study ID #: A time with e-Nature
• Status: Completed
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: June 24, 2023

Study information

• Verified date: August 2023
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: June 24, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Happiness
• Well-being

Intervention

Other:
• A Time with e-Nature
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.

Locations

Country	Name	City	State
Brazil	Parque das Neblinas	Bertioga	SP
Brazil	Reserva Particular de Patrimônio Natural Salto Morato	Guaraqueçaba	PR
Brazil	Instituto Butantan	Sao Paulo	SP
Brazil	Parque Estadual da Cantareira	São Paulo
Brazil	Parque Natural Municipal Fazenda do Carmo	São Paulo	SP
Brazil	Parque Natural Municipal Varginha	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Fundação Grupo Boticário de Proteção à Natureza

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Well-Being Index at immediate post-intervention and 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	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.	immediately pre and immediately post intervention and within 4 weeks post intervention
Secondary	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.	immediately pre and immediately post intervention and within 4 weeks post intervention
Secondary	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.	Immediately Pre intervention and within 4 weeks post intervention
Secondary	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.	Immediately Pre intervention and within 4 weeks post intervention

External Links

•   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.
•   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.