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
Verified date | August 2023 |
Source | Hospital Israelita Albert Einstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein | Fundação Grupo Boticário de Proteção à Natureza |
Brazil,
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 |
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