Secondary prevention for individuals aged 40-65 years with metabolic syndrome (MetS) Nutritional, Metabolic, Endocrine
Conditions
Interventions
The present single-centered randomized controlled trial evaluates the effect of a nature-based therapy on the biopsychosocial resilience of individuals with metabolic syndrome.
A total of 140 partic
Sponsors
Paracelsus Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Individuals aged between 40 and 65 of any gender 2. Individuals diagnosed with metabolic syndrome according to the NCEP ATP III criteria (NCEP, 2001) 3. Sedentary lifestyle: Category 1 (low physical activity) of the International Physical Activity Questionnaire – Short Form (IPAQ-SF)) 4. Low nature users: Category 1, 2 und 3 of the Monitor of Engagement with the Natural Environment Survey (MENE) – question “nature use” (Natural England, 2020) 5. Smartphone users
Exclusion criteria
Exclusion criteria: 1. Acute contraindications: 1.1. Malignant hypertension 2. Contraindications or differential diagnosis 2.1. Severe respiratory or lung disease (COPD according to GOLD Standard 3 and 4, severe asthma, emphysema) 2.2. Arteriosclerotic event (e.g. myocardial infarction) < 6 months ago 2.3. Uncontrolled metabolic diseases (e.g. uncontrolled diabetes mellitus) 2.4. insulin-dependent diabetes mellitus 2.5. Diagnosis or treatment of a malignant tumors < 3 years in the past 2.6. Orthopedic illnesses that do not allow participation in hikes 3. Factors that prevent or hinder participation in the intervention program 3.1. Alcohol abuse 3.2. Pregnancy 3.3. insufficient knowledge of German language (written and spoken) 4. Factors that prevent self-management: 4.1. Presence or indication of clinical depression (< 13 points WHO-5) 4.2. Serious other untreated psychiatric illnesses (e.g. schizophrenia) 5. Certain medication intake: 5.1. Taking preparations for weight reduction 6. Participation in another interventional study within the period of the clinical trial (t1-t4) and less than 4 weeks before the start of the trial (t1) 7. Participation in therapeutic weight loss programs within the period of the clinical study (t1-t4) and less than 8 weeks before the start of the study (t1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Biopsychosocial resilience is measured using: 1.1. Quality of Life (measured using SF-12), and 1.2. Allostatic Load Index (ALI) using following AL parameters: ALI I: DHEA-S, HRV, SBP, DBP, RHR,PEF, HDL Cholesterol, LDL Cholesterol, Triglycerides, HbA1C, Waist-hip ratio, CRP, IL-6, TNF-alpha; ALI II: DHEA-S (saliva), HRV, SBP, DBP, RHR, PEF, Waist-hip ratio, CRP (saliva)) at day 1, day 35 and day 70. 2. Perception of the intervention (affect) and short-term effects are measured via MyCap mobile app at the individual therapy sessions (3 x per week over 10 weeks): Nature Connection (INS), Individual or group setting, transportation used, Affective states (SPANE, PRS), ecological aspects, satisfaction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vital parameter and lung function parameters at day 1, day, 35, day 70 1.1. Height, weight, oxygen saturation 1.2. Forced expiratory spirometry (PEF, FEV1, FVC, MEF) 2. Laboratory parameters at day 1, day, 35, day 70 2.1. Full blood analysis (blood sampling from the vein) 3. Resilience, measured using the questionnaires State-Trait-Assessment of Resilience Scale (STARS), Perceived Stress Scale (PSR) and Brief Sense of Coherence Scale (SOC-3) at day 1, day, 35, day 70, day 180 4. Mindfulness, measured using the questionnaire Five Facet Mindfulness Questionnaire (FFMQ-15) at day 1, day, 35, day 70, day 180 5. Physical activity, measured using the questionnaire International Physical Activity Questionnaire – Short Form (IPAQ-SF) at day 1, day, 35, day 70, day 180 6. Nature contact, measured using the questionnaires Inclusion of Nature in Self Scale (INS), Nature Connectedness Index (NCI), Direct & Indirect Nature Contact at day 1, day, 35, day 70, day 180 7. Subjective well-being and quality of life, measured using the questionnaires Intercultural Quality of Life Comic (iQOLC) and OECD-4 at day 1, day, 35, day 70, day 180 8. Loneliness, measured using the questionnaire the De Jong Gierveld Loneliness Scale at day 1, day, 35, day 70, day 180 9. Community cohesion, measured using the questionnaire Community Cohesion Scale at day 1, day, 35, day 70, day 180 10. Motivation, using the questionnaire Ideal self, and self-determined motivation Furthermore, the following integrative evaluation parameters will be assessed: 1. Environmental aspects, measured using the questionnaires Perception of local nature (PANS-6), Environmental concerns, Revised Pro-Environmental Behavior Scale (R-PEBS) at day 1, day, 35, day 70, day 180 2. Health economic aspects: 2.1. QUALYs (calculation from SF-12) 2.2. Use of Care Services (day 70, day 180) 2.3. Willingness to pay via contingent valuation method (CVM) at day 70 3. Process evaluation, measured via questionnaires assessing the satisf | — |
Countries
Austria
Contacts
Public ContactChristina Pichler
Outcome results
None listed