Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors
- Conditions
- Metabolic Syndrome, Protection Against
- Interventions
- Behavioral: Forest Therapy (Düppeler Forst - Berlin-Wannsee)
- Registration Number
- NCT04781491
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Forest Therapy (Düppeler Forst - Berlin-Wannsee) Forest Therapy (Düppeler Forst - Berlin-Wannsee) 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.
- Primary Outcome Measures
Name Time Method • 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
Name Time Method • Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] Assessing full scale, range 0-56, higher score meaning a better outcome
• International Physical Activity Questionnaire (IPAQ) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] 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• Flourishing Scale (FS-D) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] 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
• Perceived Stress Scale (PSS) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived•stress. Higher score meaning more stress
• Hospital Anxiety and Depression Scale (HADS) 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 • Weekly query of the exercise practice by means of (online) diary Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] • Short Form 12 Health Survey (SF-12) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] 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.
• Physical complaints (B-LR - Beschwerden-Liste) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] 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
Perceived Benefits of Nature Questionnaire (PBNQ) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks Assessing full scale, range 1-7, lower score meaning a better outcome
• General Self-Efficacy Short Scale (ASKU-Allgemeine Selbstwirksamkeit Kurzskala) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] Measurement instrument for recording subjective competence expectations. Scale ranging from 1-5, higher score meaning a better outcome
Subjective Vitality Scale state (SVS-G state) Date of Inclusion (Baseline), after 8 weeks and after 16 weeks Assessing full scale, range 1-80, higher score meaning a better outcome
Trial Locations
- Locations (1)
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
🇩🇪Berlin, Germany