Metabolic Syndrome, Protection Against
Conditions
Keywords
Forest Therapy, Forest Bathing, Shinrin Yoku, Metabolic Syndrome, Cardiovascular Risks
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).
Interventions
BEHAVIORALForest Therapy (Düppeler Forst - Berlin-Wannsee)
Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| • 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 |
| • 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 |
| • Hospital Anxiety and Depression Scale (HADS) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | — |
| • 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 |
| • 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 |
| • 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 |
| • 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) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks | Assessing full scale, range 1-80, higher 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 |
| Profile of Mood States (POMS) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks | — |
| • 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| • Heart rate variability and other parameters | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | \- Digital tracking using wearables: parameters of stress levels and activity and sleep patterns are measured objectively using a smartwatch (fitbit). Heart rate variability (RMSSD), pulse, activity duration, type, and intensity as well as sleep duration, sleep phases, steps, and calorie consumption are recorded. The aim is to test whether the activity and pulse tracking data provide information about the variance in quality of life data. Will be combined to report quality of life. |
| - bioelectrical impedance analysis (BIA) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg) |
| Heart Rate (HR) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 24h measuring by smartwatch |
| - Blood count | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| Interbeat Interval (IBI) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 24h measuring by smartwatch |
| Number of steps | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 24h measuring by smartwatch |
| Heart Rate Variability (HRV) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 24h measuring by smartwatch |
| - Blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - Parameters of glucose metabolism (insulin, glucose, HbA1C, insulin sensitivity) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters will be combined to report Diabetes status |
| - liver function (GOT, GPT, GGT) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - Inflammation: hs-CRP, IL-6 | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - IFN-gamma, tumor necrosis factor alpha | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - uric acid | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - Lymphocyte populations: T cells (CD3), B cells (CD19), NK cells (CD16). | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - T cell subpopulations: T helper cells (CD4), cytotoxic T cells (CD8), CD4/CD8 ratio. | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - ferritin | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| - cumulative steroid hormone concentration of the last 2 months in a hair strand | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | Laboratory parameters |
| • Apparatus parameters | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | * Body weight * abdominal girth * blood pressure measurement (24h) will be combined to report metabolic syndrome |
| • Qualitative evaluation (focus group interviews) | Date of Inclusion (Baseline), after 8 weeks and after 16 weeks] | \- Semi-structured interviews and focus group discussions with 16 subjects of the intervention group. |
Countries
Germany
Contacts
Primary ContactMiriam Rösner
Outcome results
None listed