Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors

Study Overview
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Brief Summary
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The aim of this study is to investigate the effects of regular forest therapy under guidance of a licensed nature therapist on patients with metabolic syndrome and cardiovascular risks

Detailed Description
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It is assumed that nature and forest experience has sustainable benefits for the physical and mental health of individuals with metabolic syndrome and cardiovascular risk profile. Especially co-therapeutic effects in terms of resilience and salutogenesis might effectively and sustainably promoted by nature and forest therapy. The main objective of this study is to measure the effects of nature and forest therapy in subjects with manifest metabolic syndrome and cardiovascular risk factors. The intervention is a stay in the nature of the Düppeler Forest (Berlin-Wannsee) under the guidance of trained nature guides (90 minutes, 1x/week over 2 months), who teach exercises on the perception of nature and the connection between nature and health, movement and mindfulness. Subjects are also motivated to experience forest nature as regularly as possible (recommended ≥ 30 minutes daily). Participants of the control group will be offered a later participation in the therapy program after completion of the last study visit after 4 months (waiting list control group).

Official Title
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Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors - a Randomized Controlled Trial

Conditions
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Metabolic Syndrome, Protection Against

Intervention / Treatment
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* Behavioral: Forest Therapy (Düppeler Forst - Berlin-Wannsee)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Definition of Metabolic Syndrome according to the International Diabetes Foundation (IDF): waist circumference: at least 94 cm for men, at least 80 cm for women plus at least two of the following risk factors: fasting blood glucose levels of > 100 mg/dl (> 5.6 mmol/l) measured in blood plasma or diagnosed diabetes mellitus elevated triglycerides > 150 mg/dl (> 1.7 mmol/l) or therapy already initiated to lower triglycerides low HDL cholesterol: < 40 mg/dl (< 1.05 mmol/l) in men and < 50 mg/dl (< 1.25 mmol/l) in women or already initiated therapy to increase HDL Hypertension (from > 130 mmHg systolic and > 85 mmHg diastolic) or already treated hypertension Exclusion Criteria: Serious acute or chronic illnesses Immobility or limitation of mobility due to orthopedic, neurological or other medical cause Participation in another study Serious mental illness Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Forest Therapy (Düppeler Forst - Berlin-Wannsee)<br>Subjects receive a 90-minute Forest Therapy session once per week for 8 weeks with a licensed nature therapist, who explains exercises on perceiving nature and the connection between nature and health. | Behavioral: Forest Therapy (Düppeler Forst - Berlin-Wannsee)<br>* Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna<br>|
| No Intervention: Waiting list<br>Subjects don't receive any therapy but are offered the same treatment after trial is finished. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington |  | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Perceived Stress Scale (PSS) | Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived•stress. Higher score meaning more stress | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • Short Form 12 Health Survey (SF-12) | The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health.The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. score ranging from 0-5 for each question, lower score meaning a better outcome. | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • Physical complaints (B-LR - Beschwerden-Liste) | the Complaints List - (B-LR) is a self-assessment procedure for recording subjective impairment due to physical or general complaints, covering the entire spectrum from no complaints to severe impairment. Two parallel forms (B-LR and B-LR') are available, each consisting of 20 items, lower score meaning a better outcome | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • Flourishing Scale (FS-D) | The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score, ranging from 8-56, higher score meaning a better outcome | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • Hospital Anxiety and Depression Scale (HADS) |  | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) | Assessing full scale, range 0-56, higher score meaning a better outcome | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • General Self-Efficacy Short Scale (ASKU-Allgemeine Selbstwirksamkeit Kurzskala) | Measurement instrument for recording subjective competence expectations. Scale ranging from 1-5, higher score meaning a better outcome | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • International Physical Activity Questionnaire (IPAQ) | The 31-item long form and the 9-item short form assess time spent on different activities. The short form records four types of physical activity: vigorous activity such as aerobics; moderate-intensity activity such as leisure cycling; walking, and sitting. MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS; higher score meaning better outcome; range 0 to around 3000 MET minutes a week | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| • Weekly query of the exercise practice by means of (online) diary |  | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | 
| Subjective Vitality Scale state (SVS-G state) | Assessing full scale, range 1-80, higher score meaning a better outcome | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks | 
| Perceived Benefits of Nature Questionnaire (PBNQ) | Assessing full scale, range 1-7, lower score meaning a better outcome | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks | 
| Profile of Mood States (POMS) |  | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forest Therapy, Forest Bathing, Shinrin Yoku, Metabolic Syndrome, Cardiovascular Risks