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Enhancing well-being and resilience through nature-based mindfulness activities. The case study of Padua with people at risk of metabolic disorder (NATURE-MET-P)

Randomised controlled trial examining the efficacy of an urban nature-based therapy for increased biopsychosocial resilience amongst sedentary individuals at risk of metabolic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74582097
Enrollment
140
Registered
2024-09-09
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychophysiological parameters in participants at risk of metabolic syndrome Nutritional, Metabolic, Endocrine

Interventions

Current interventions, as of 18/06/2025: A total of 140 participants will be recruited and randomly assigned to either the intervention or control group, balancing for gender and age. Participants f

Sponsors

University of Padua
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 18/06/2025: 1. People at risk of metabolic syndrome (at least two of five of the following criteria): 1.1. Abdominal obesity: Waist circumference >102 cm (men), >88 cm (women) 1.2. Triglycerides: =150 mg/dL or Rx 1.3. HDL cholesterol: 102 cm (men), >88 cm (women) 1.2. Triglycerides: =150 mg/dL or Rx 1.3. HDL cholesterol: <40 mg/dL (men), <50 mg/dL (women) or Rx 1.4. Blood pressure: =130/=85 mmHg or Rx 1.5. Fasting glucose: =110mg/dL or Rx 2. 40-65 years old 3. Sedentary behavior [Category 1 (Low) or 2 (Moderate) of IPAQ-SF] 4. Ability to participate in tours in urban green areas 5. Low nature contact (probably <30 min/week actively engaged)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 18/06/2025: 1. Active lifestyle (Category 3 [High] of IPAQ-SF) 2. Pregnancy 3. Enrollment in any other interventional clinical trial _____ Previous exclusion criteria: 1. Active lifestyle (Category 3 [High] of IPAQ-SF) 2. Pregnancy 3. Enrollment in any other interventional clinical trial 4. Acute depression

Design outcomes

Primary

MeasureTime frame
1. Biopsychosocial resilience is measured using these measures on day 0, day 35 and day 70: 1.1. Quality of Life measured using SF-12 1.2. Allostatic Load Index (ALI) measured using the following parameters: 1.2.1. Heart Rate Variability (HRV) 1.2.2. Systolic Blood Pressure (SBP) 1.2.3. Diastolic Blood Pressure (DBP) 1.2.4. Resting Heart Rate (RHR) 1.2.5. Peak Expiratory Flow (PEF) 1.2.6. Waist-hip ratio 1.2.7. C-Reactive Protein (CRP) (saliva) 2. Perception of the intervention (affect) and short-term effects are measured via the MyCap mobile app at the individual therapy sessions (3 x per week over 5 weeks): 2.1. Nature connectedness measured using Inclusion of Nature with Self (INS) 2.2. Transportation used measured using ad hoc question 2.3. Affective states: 2.3.1. Emotions measured using the Scale of Positive and Negative Experience (SPANE) 2.3.2. Perceived restorativeness measured using the Perceived Restorativeness Scale (PRS) 2.4. Ecological aspects measured using ad hoc questions 2.5. Satisfaction measured using ad hoc questions

Secondary

MeasureTime frame
Measured on day 0, day 35 and day 70 (unless indicated): 1. Sociodemographic information collected using ad hoc questions (day 0 only) 2. Trait mindfulness measured using the Five Facet Mindfulness Questionnaire (FFMQ-15) 3. Environmental habits and childhood experiences (only day 0) from PANS-M1Q1 - People & Nature Survey, 2021 4. Current indirect contact with nature from PANS-M1Q1 - People & Nature Survey, 2021 5. Physical activity measured using the International Physical Activity Questionnaire Short Form (IPAQ-SF) 6. Subjective well-being measured using the Organisation for Economic Co-operation and Development Survey (OECD-4) 7. Well-being, emotions measured using the Scale of Positive and Negative Experience (SPANE) 8. Loneliness measured using the De Jong Gierveld Loneliness Scale 9. Environmental concern measured using the Environmental Concern Scale 10. Local nature attitudes measured using the People & Nature Survey (PANS-6) 11. Pro-environmental behaviors measured using Pro-environmental Behaviors Scale (RPEBS) 12. Resilience measured using the State-Trait Assessment of Resilience Scale (STARS) 13. Perceived restorativeness measured using Perceived Restorativeness Scale (PRS) 14. Motivation (self-determined motivation) measured using Ideal Self, ad hoc scale 15. Acceptability measured using Sekhon et al, 2018 scale 16. Nature connectedness measured using the Nature Connectedness Index (NCI) 17. Sense of community measured using the Brief Sense of Community Scale 18. Social desirability measured using the Marlowe-Crowne Social Desirability Scale (MC-SDS) 19. Contingent evaluation (willingness to pay) measured using an ad hoc scale (only at day 70) 20. Use of care services (cost savings) measured using an ad hoc scale Moreover, at day 180 the following integrative evaluation parameters will be assessed: 1. Use of care services (cost savings) measured using an ad hoc scale 2. Overall satisfaction with the program measured using an

Countries

Italy

Contacts

Public ContactMonica Bolognesi
monica.bolognesi@studenti.unipd.it+39 (0)3496721467

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026