Nature Based Therapy With Mindful Walks in Urban Coastal Setting - Barcelona (Spain)

NCT06622629 | Completed

• 2 other identifiers: 2024/11524/I101081420 RESONATE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the NATURE-MET-B (Barcelona) study is to analyze the effects of a Nature-based Therapy (NbT) on the biopsychological resilience of adults general population through changes in: i) health-related quality of life and ii) allostatic load (physiological stress). The secondary objective is to provide data on the environmental, social, and economic aspects of the intervention in order to refine specific prevention programs and establish programs that include NbT as a secondary preventive measure in healthcare. Analogous to NATURE-MET-B, two similar NbT studies will be carried out in Padua (Italy) and Salzburg (Austria) for the secondary prevention of Metabolic Syndrom (MetS). These are not multicenter studies but three comparable studies with similar inclusion and exclusion criteria in all study locations. Only the types of landscape and natural exposure sites differ: Barcelona-Coastal Urban, Padua-Urban Green, Salzburg-Mountainous Rural.

Conditions

Healthy Participants

Keywords

social prescription; Social-ecological system; stress; quality of life; blue health; resilience; nature based therapy

Outcome Measures

Primary Outcomes (3)

• Health-related quality of life (SF-12)

  The SF-12 (Short Form 12) is a widely used survey instrument that measures health-related quality of life (HRQoL). It is a shorter version of the SF-36, designed to assess a person´s physical and mental health status through 12 questions. The SF-12 provides a quick and reliable means to evaluate the impact of health on an individual's quality of life, making it useful in clinical settings and research.

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

• Allostatic Index-ALI

  The Allostatic Index (ALI) is a biomarker-based measure designed to assess the cumulative physiological burden of stress on the body over time. It reflects the wear and tear on the body caused by chronic stress and the body\'s response to it, offering insights into an individual\'s health status and risk for various diseases.

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

• Scale of Positive and Negative Experience (SPANE)

  The Scale of Positive and Negative Experience (SPANE) is a brief, self-report measure designed to assess an individual\'s emotional experiences over a specified period. SPANE provides insights into both positive and negative feelings, contributing to the broader understanding of subjective well-being and emotional health.

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

Secondary Outcomes (20)

• Environmental Concerns

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

• Revised Pro-Environmental Behavior Scale (R-PEBS)

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

• Quality-Adjusted Life Years (QUALYs)

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

• Healthcare and Social System Utilization (Cost Savings)

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

• Willingness to Pay (WTP)

  From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)

Study Arms (2)

Intervention Grop

EXPERIMENTAL

* Adults aged \>=18 years * Smartphone users * Understand Spanish and/or Catalan language

Other: Nature based Therapy (NbT): Planned therapeutic techniques performed in natural settings and based on nature-human active participation and connection

Control group

ACTIVE COMPARATOR

* Adults aged \>=18 years * Smartphone users * Understand Spanish and/or Catalan language The control group participants are assessed at the same time as those in the intervention group (t1, t2, and t3). Participants in the control group will be offered the opportunity to benefit from the NbT once the follow-up period is completed (day 70).

Other: Waiting List

Interventions

Nature based Therapy (NbT): Planned therapeutic techniques performed in natural settings and based on nature-human active participation and connection OTHER

The intervention consists of a 5-week (35-day) conscious immersion treatment in a natural coastal urban environment, involving approximately three sessions per week of semi-structured walking and mindfulness exercises lasting 60 minutes. Following this, there will be a follow-up period that will end 5 weeks after the intervention has concluded (day 70). Participants will document and evaluate the therapy sessions at the location where the mindfulness exercises take place, using the mobile phone application App, a digital tool for assessing the environment and health. The aim is to integrate nature-based physical activity and relaxation sessions into daily life. The intervention will be standardized as much as possible to allow comparison of the results with those from the other study centers in Salzburg (Vienna) and Padua (Italy).

Intervention Grop

Waiting List OTHER

Participants in the control group will be offered the opportunity to benefit from the NbT once the follow-up period is completed (day 70).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>=18 years
• Smartphone users

You may not qualify if:

• Acute contraindications
• \- Malignant hypertension
• Contraindications or differential diagnosis
• Severe respiratory or pulmonary disease (COPD, severe asthma, emphysema)
• Arteriosclerotic incident (e.g., myocardial infarction) 6 months previous the study starting
• Heart failure
• Uncontrolled metabolic diseases (e.g., diabetes mellitus)
• Diagnosis or treatment of a malignant disease \< 3 years ago
• Chronic immunological diseases (e.g., rheumatoid arthritis)
• Orthopedic conditions that prevent participation in excursions
• Factors that prevent or hinder participation in the intervention program
• Alcohol or substance abuse (except nicotine)
• Pregnancy
• Insufficient knowledge of Spanish or Catalan (written and spoken/questionnaires)
• Factors that prevent self-management

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead

Study Sites (1)

ISGlobal

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: September 2, 2024
• Primary Completion: July 30, 2025
• Study Completion: October 22, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)