Clinical trial NCT05486156: Evaluation of a Multicomponent Nature-based Intervention for Well-being and Relationship With Nature
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Happiness
Keywords: Nature exposure
Multicomponent treatment
Randomized clinical trial
Well-being
Connection with nature
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Fundação Grupo Boticário de Proteção à Natureza
First posted: 2022-08-03
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be separated into two groups during the study, the intervention group (IG) and the control group (CG).
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Well-Being Index at 30 days follow-up.
timeFrame: immediately pre and immediately post intervention and within 4 weeks post intervention
Secondary outcomes:
measure: Change from baseline self-perception of happiness at immediate post-intervention and 30 days follow-up.
timeFrame: immediately pre and immediately post intervention and within 4 weeks post intervention
measure: Change from baseline vitality at immediate post-intervention and 30 days follow-up.
timeFrame: immediately pre and immediately post intervention and within 4 weeks post intervention
measure: Change of Connection with Nature from baseline to 30 days post-intervention
timeFrame: Immediately Pre intervention and within 4 weeks post intervention
measure: Change from baseline nature engagement at 30 days after intervention
timeFrame: Immediately Pre intervention and within 4 weeks post intervention
Other outcomes:
measure: Perception at the end of nature-based experience
timeFrame: Immediately Post intervention
Locations:
city: Guaraqueçaba
country: Brazil
facility: Reserva Particular de Patrimônio Natural Salto Morato
state: PR
city: Bertioga
country: Brazil
facility: Parque das Neblinas
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto Butantan
state: SP
city: São Paulo
country: Brazil
facility: Parque Natural Municipal Varginha
state: SP
city: São Paulo
country: Brazil
facility: Parque Natural Municipal Fazenda do Carmo
state: SP
city: São Paulo
country: Brazil
facility: Parque Estadual da Cantareira
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Eliseth R Leão, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: Roberta M Savieto, MNP
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein
name: Denise TN Maki, MD
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein
name: Letícia B Oliveira, BSN
role: STUDY_CHAIR
affiliation: São Paulo Municipal Secretary of Green and the Environment
name: Luccas GR Longo, MSc
role: STUDY_CHAIR
affiliation: Butantan Institute
name: Luciano M Lima, MSc
role: STUDY_CHAIR
affiliation: Butantan Institute
name: Erika Hingst-Zaher, Phd
role: STUDY_CHAIR
affiliation: The Medical School (FMB) of São Paulo State University (Unesp),
name: Karina P Patricio, PhD
role: STUDY_CHAIR
affiliation: The Federal University of Technology - Paraná
name: Gustavo Borba, PhD
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein
name: Lital Bass, BSN
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein
name: Sabrina Bomfim
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein
name: Floriana Bertini, MD
role: STUDY_CHAIR
References: