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

NCT04781491 | Unknown

• 1 other identifier: Wald
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome, Protection Against

Keywords

Forest Therapy; Forest Bathing; Shinrin Yoku; Metabolic Syndrome; Cardiovascular Risks

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (12)

• • Perceived Stress Scale (PSS)

  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]

• • Physical complaints (B-LR - Beschwerden-Liste)

  Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]

• • Flourishing Scale (FS-D)

  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]

Other Outcomes (19)

• - Blood count

  Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]

• - Blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)

  Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]

• - Parameters of glucose metabolism (insulin, glucose, HbA1C, insulin sensitivity)

  Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]

Study Arms (2)

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.

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.

Interventions

Forest Therapy (Düppeler Forst - Berlin-Wannsee) BEHAVIORAL

Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna

Forest Therapy (Düppeler Forst - Berlin-Wannsee)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Relaxation Therapy; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Andreas Michalsen, Prof. Dr.

  Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam Rösner

CONTACT

00493080505682; m.roesner@immanuel.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.med

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 4, 2021
• Study Start: June 27, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)