Can nature-based therapy with exercise and mindfulness boost biopsychosocial resilience in people with metabolic syndrome?

Not Applicable

Conditions: Secondary prevention for individuals aged 40-65 years with metabolic syndrome (MetS)
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN14169596

Lead Sponsor: Paracelsus Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 140

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Biopsychosocial resilience is measured using:<br>1.1. Quality of Life (measured using SF-12), and<br>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.<br>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 Outcome Measures