Clinical trial NCT06622629: Nature Based Therapy With Mindful Walks in Urban Coastal Settings for Metabolic Syndrome - Barcelona (Spain)
Official title: NATURE-based Therapy for METabolic Syndrome (NATURE-MET-B)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome X
Stress
Keywords: nature based therapy, resilience,
social prescription
Social-ecological system
stress
quality of life
allostatic load
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 a group of sedentary patients with metabolic syndrome (MetS) and little contact with nature, through changes in: i) health-related quality of life and ii) allostatic load. 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 NbTas a secondary preventive measure in healthcare for MetS.

Analogous to NATURE-MET-B, two similar NbT studies will be carried out in Padua (Italy) and Salzburg (Austria) for the secondary prevention of MetS. These are not multicenter studies but three comparable studies with the same inclusion and exclusion criteria for MetS patients in all study locations. Only the types of landscape and natural exposure sites differ: Barcelona-Coastal Urban, Padua-Urban Green, Salzburg-Mountainous Rural.


Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of metabolic syndrome according to the ATPIII (Adult Treatment Panel III of the National Cholesterol Education Program) criteria. According to the ATP III definition, metabolic syndrome is present if at least three of the following five criteria are met (NCEP, 2001):

  * Abdominal fat distribution: waist circumference \&gt;102 cm (men), \&gt;88 cm (women)
  * Serum triglycerides ≥150 mg/dL
  * HDL cholesterol: \&lt;40 mg/dL (men), \&lt;50 mg/dL (women)
  * Blood pressure: ≥130/≥85 mmHg
  * Fasting glucose: ≥110 mg/dL
* Sedentary/inactive lifestyle: Category 1 (low physical activity) of the International Physical Activity Questionnaire - Short Form (IPAQ-SF) (International Physical Activity Questionnaire, 2005)
* Low nature use (\&#34;infrequent users of nature\&#34;): Categories 1, 2, and 3 of the Monitor of Engagement with the Natural Environment Survey (MENE) - \&#34;Nature use\&#34; question (Natural England, 2020)
* Smartphone users

Exclusion Criteria:

* Acute contraindications

  - Malignant hypertension
* Contraindications or differential diagnosis

  * Severe respiratory or pulmonary disease (COPD, severe asthma, emphysema)
  * Arteriosclerotic incident (e.g., myocardial infarction) \&lt; 6 months ago
  * Heart failure
  * Uncontrolled metabolic diseases (e.g., diabetes mellitus)
  * Diagnosis or treatment of a malignant disease \&lt; 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
  * Moderate to severe depression (score \&lt; 13 points on the WHO-5)
  * Other untreated severe psychiatric illnesses (e.g., schizophrenia)
  * Taking certain medications
  * Use of weight loss supplements
  * Participation in another clinical intervention trial
  * Participation in therapeutic weight loss programs

Primary outcomes:
measure: Health-related quality of life (SF-12)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Allostatic Index-ALI
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Scale of Positive and Negative Experience (SPANE)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
Secondary outcomes:
measure: Environmental Concerns
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Revised Pro-Environmental Behavior Scale (R-PEBS)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Quality-Adjusted Life Years (QUALYs)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Healthcare and Social System Utilization (Cost Savings)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Willingness to Pay (WTP)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Nature Connectedness Index (NCI)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Five Facet Mindfulness Questionnaire- FFMQ-15
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: State-Trait-Assessment of Resilience Scale (STARS)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Perceived Stress Scale (PSS)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Subjective well-being and quality of life-OCDE-4
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: De Jong Gierveld Loneliness Scale
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Brief Sense of Community Scale (BSCS)
timeFrame: From starting to the end of the intervention (5 weeks)
measure: Social Desirability Scale - Short Form
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Self-Determined Motivation Scale (SDMS)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Ideal Self
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Perception of local nature (PANS-6)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Environmental Attitudes/Environmental concerns
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: Perceived Restorativeness Scale (PRS)
timeFrame: From starting to the end of the intervention (5 weeks)
measure: Five Facet Mindfulness Questionnaire- FFMQ-15
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
measure: International Physical Activity Questionnaire (IPAQ - Short Form)
timeFrame: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: ISGlobal
Study officials:
References: