Metabolic Syndrome, Protection AgainstNCT04781491
Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors
A study testing Forest Therapy (Düppeler Forst - Berlin-Wannsee) in people with Metabolic Syndrome, Protection Against, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Protection Against
- What is being tested?
- Forest Therapy (Düppeler Forst - Berlin-Wannsee)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jun 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
Miriam Rösner, study nurse, 00493080505682, m.roesner@immanuel.de
Andreas Michalsen, Prof. Dr.
About this study
Official title: Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors - a Randomized Controlled Trial
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
Read the 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).
- Conditions
- Metabolic Syndrome, Protection Against
- Being tested
- Forest Therapy (Düppeler Forst - Berlin-Wannsee)
- Keywords
- Forest Therapy, Forest Bathing, Shinrin Yoku, Metabolic Syndrome, Cardiovascular Risks
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forest Therapy (Düppeler Forst - Berlin-Wannsee)Behavioural
Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna
| Study group | Role | What they receive |
|---|---|---|
| Forest Therapy (Düppeler Forst - Berlin-Wannsee) | Experimental | 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. Receives: Behavioral: Forest Therapy (Düppeler Forst - Berlin-Wannsee) |
| Waiting list | No intervention | Subjects don't receive any therapy but are offered the same treatment after trial is finished. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary outcomes (12)
• 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Hospital Anxiety and Depression Scale (HADS)
Measured: 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
Measured: 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
Measured: 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
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Weekly query of the exercise practice by means of (online) diary
Measured: 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
Measured: 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
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Profile of Mood States (POMS)
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start27 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome, Protection AgainstStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781491
- Sponsor's protocol ID
- Wald
- Status last verified
- Oct 2023
- First submitted
- 23 Feb 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04781491
- Acronym / sponsor ID
- Wald
- Conditions
- Metabolic Syndrome, Protection Against
- Keywords
- Forest Therapy, Forest Bathing, Shinrin Yoku, Metabolic Syndrome, Cardiovascular Risks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forest Therapy (Düppeler Forst - Berlin-Wannsee) | Experimental | Behavioral: 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. |
| Waiting list | No intervention | –Subjects don't receive any therapy but are offered the same treatment after trial is finished. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forest Therapy (Düppeler Forst - Berlin-Wannsee)Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna | Behavioural | Forest Therapy (Düppeler Forst - Berlin-Wannsee) |
Primary outcome
• Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
12 secondary outcomes
• Perceived Stress Scale (PSS)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Short Form 12 Health Survey (SF-12)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Physical complaints (B-LR - Beschwerden-Liste)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Flourishing Scale (FS-D)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Hospital Anxiety and Depression Scale (HADS)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• General Self-Efficacy Short Scale (ASKU-Allgemeine Selbstwirksamkeit Kurzskala)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• International Physical Activity Questionnaire (IPAQ)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
• Weekly query of the exercise practice by means of (online) diary
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Subjective Vitality Scale state (SVS-G state)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Perceived Benefits of Nature Questionnaire (PBNQ)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Profile of Mood States (POMS)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest Therapy (Düppeler Forst - Berlin-Wannsee) in people with Metabolic Syndrome, Protection Against, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Rösner (00493080505682, m.roesner@immanuel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington (time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.