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Clinical Trials/NCT05486156
NCT05486156
Completed
N/A

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

Hospital Israelita Albert Einstein6 sites in 1 country486 target enrollmentOctober 8, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Well-being
Sponsor
Hospital Israelita Albert Einstein
Enrollment
486
Locations
6
Primary Endpoint
Change from baseline Well-Being Index at 30 days follow-up.
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
October 8, 2022
End Date
June 24, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change from baseline nature engagement at 30 days after intervention(Immediately Pre 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 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)

Study Sites (6)

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