NATURE-based Therapy in Urban Coast in Barcelona (NATURE-MET-B)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Allostatic Index-ALI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults >=18 years
- •Smartphone users
排除标准
- •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
- •Moderate to severe depression (score < 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
结局指标
主要结局
Allostatic Index-ALI
时间窗: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
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.
Scale of Positive and Negative Experience (SPANE)
时间窗: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
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.
Health-related quality of life (SF-12)
时间窗: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
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.
Health-related quality of life (SF-12)
时间窗: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
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.
Allostatic Index-ALI
时间窗: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
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.
Scale of Positive and Negative Experience (SPANE)
时间窗: From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks)
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.
次要结局
- 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))
- Nature Connectedness Index (NCI)(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- State-Trait-Assessment of Resilience Scale (STARS)(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Perceived Stress Scale (PSS)(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Subjective well-being and quality of life-OCDE-4(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- De Jong Gierveld Loneliness Scale(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Brief Sense of Community Scale (BSCS)(From starting to the end of the intervention (5 weeks))
- Social Desirability Scale - Short Form(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Self-Determined Motivation Scale (SDMS)(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Ideal Self(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Perception of local nature (PANS-6)(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Environmental Attitudes/Environmental concerns(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Perceived Restorativeness Scale (PRS)(From starting to the end of the intervention (5 weeks))
- International Physical Activity Questionnaire (IPAQ - Short Form)(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))
- Five Facet Mindfulness Questionnaire- FFMQ-15(From enrollment to the end of treatment of treatment (5 weeks) and follow up (10 weeks))