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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05893212
Other study ID # HUS/3520/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date December 31, 2020

Study information

Verified date May 2023
Source University of Helsinki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Contact with nature promotes human wellbeing through diverse pathways, providing a potential way to support health especially in primary care, where patients commonly suffer from multimorbidity and poor general health. Social prescribing as a non-pharmaceutical treatment is a promising method to improve health as well as inclusion. This study explores and compares the effects of a nature based and an exercise based social prescribing scheme on mental wellbeing, physical activity and sleep, in a primary care population.


Description:

In this non-randomized, intention-to-treat, pilot study we recruited clients at the health and social service centre in Sipoo, Finland. Participants (n=79) chose between two social prescribing programs, either taking part of guided walks in nature, including immersion in a forest with high biodiversity, or taking part in a sports group with a versatile program. Inclusion was not based on diagnosis, but an identified need of improving health. Mental wellbeing was assessed using the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), additional questions evaluated perceived health and sleep. Amount and quality of sleep and physical activity were measured using wrist-worn accelerometers. Assessments took place before and after the 8-week intervention, as we were interested in the effect on everyday life. Even though participants lived in an area with abundant green space, taking part in the prescribed nature program improved mental wellbeing. Those who initially rated their health and mental health as good did achieve benefit from both programs, while those in poor health received better aid from the nature group. Initial study plan aimed for 160 participants, with an equal distribution between the groups. The programs were completed in 2018-2019 (spring + autumn) The COVID-19 outbreak hindered group activities 2020, a nature-group was organized in autumn 2020.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Need of health promotion or secondary prevention of disease as identified by health care professionals or by social care professionals working in a public health care center (nurse, doctor, or social worker). - Enrolment was not based on a diagnosis, but health care and social care professionals were instructed to identify patients/clients they felt could benefit from a targeted health intervention and involve particularly those in poor general health. - Adults with a physical ability to slowly walk approximately 3 km in a slow tempo. - Ability to understand and give consent to participation. - Age 18 years or older. Exclusion Criteria: - Untreated medical condition hindering physical activity or symptomatic condition demanding continuous attention. - Disability preventing ability to move in terrain. - Inability to take part in group-based activities due to, e.g., behavioral challenges. Although reason of referral is not reported, enrolment in intervention was part of real-life treatment. Eligibility was assessed by professionals referring to the intervention, as well as at the introductory meeting organized by the staff at the public health care center taking place before the intervention started. It was possible to take part in the intervention but not the study, participants in the study signed an informed consent allowing use of data and giving permission for later contact. Participants were free to withdraw from the study at any time without giving a reason, and this did not interfere with their care in any way.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nature based facilitated group intervention
The Nature-group programme included learning more about local outdoor areas and nature itself, the biotopes visited were chosen to provide a various nature experience, including forests, farmland, lakes, and seashore. Accompanied by nature guides the group practiced simple sensorial exercises that enhance the contact with nature and its microbiome.
Exercise in group
The Sports-group participated in an exercise programme and met weekly in community sports facilities. Exercise we define as a planned, structured, repetitive, and purposeful form of physical activity that aims for improvement or maintenance of one or more components of physical fitness. The sports programme was planned and executed by professional sports leaders in cooperation with health professionals and included both aerobic and anaerobic exercise as well as team sports, content was planned according to current best practice and considered the participants physical ability.

Locations

Country Name City State
Finland Sipoo Social and Health center Sipoo Itä-Uusimaa

Sponsors (4)

Lead Sponsor Collaborator
University of Helsinki Finnish Institute for Health and Welfare, Luonnontie, Municipality of Sipoo, Health and Social services

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in positive mental well-being Self-assessed mental wellbeing measured with the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). At beginning of study (day 0), 4.th meeting (day 28) and at end of study (day 56-58)
Primary Change in self rated health Question: How is your health at the moment? Likert-like scale: 1-5 At beginning of study (day 0), 4.th meeting (day 28) and at end of study (day 56-58)
Primary Change in self rated mental health Question: How is your mental health at the moment? Likert-like scale: 1- 5 (much/good/well). At beginning of study (day 0), 4.th meeting (day 28) and at end of study (day 56-58)
Primary Change in functioning ability Question: How is your functioning ability at the moment? Likert-like scale: 1-5 At beginning of study (day 0), 4.th meeting (day 28) and at end of study (day 56-58)
Primary Change in percieved sleep Question: How do you sleep at the moment? Likert-like scale: 1-5 At beginning of study (day 0), 4.th meeting (day 28) and at end of study (day 56-58)
Secondary Change in total sleep time For objective measurement of amount and quality of activity and sleep, participants kept a wrist worn accelerometer (ActiGraph GT9X Link, Actigraph LLC, Pensacola, Florida, USA).
Sleep is reported total sleep time, time in bed and sleep efficiency. After sleep onset the number and length of awakenings is also reported.
Before starting intervention (day 0) and after intervention (day 56-60)
Secondary Change in time in bed. For objective measurement of amount and quality of activity and sleep, participants kept a wrist worn accelerometer (ActiGraph GT9X Link, Actigraph LLC, Pensacola, Florida, USA).
Sleep is reported total sleep time, time in bed and sleep efficiency. After sleep onset the number and length of awakenings is also reported.
Before starting intervention (day 0) and after intervention (day 56-60)
Secondary Change in sleep efficiency For objective measurement of amount and quality of activity and sleep, participants kept a wrist worn accelerometer (ActiGraph GT9X Link, Actigraph LLC, Pensacola, Florida, USA).
Sleep is reported total sleep time, time in bed and sleep efficiency. After sleep onset the number and length of awakenings is also reported.
Before starting intervention (day 0) and after intervention (day 56-60)
Secondary Change in number and length of awakenings after sleep onset For objective measurement of amount and quality of activity and sleep, participants kept a wrist worn accelerometer (ActiGraph GT9X Link, Actigraph LLC, Pensacola, Florida, USA).
After sleep onset the number and length of awakenings is also reported.
Before starting intervention (day 0) and after intervention (day 56-60)
Secondary Change in light physical activity For objective measurement of amount and quality of activity and sleep, participants kept a wrist worn accelerometer (ActiGraph GT9X Link, Actigraph LLC, Pensacola, Florida, USA). As we are interested in the effects on everyday life, accelerometer data was not collected during the intervention itself, but before starting the program and after the intervention. Data shows the number of active days with the minimum of 10 hours of wear time from midnight-to-midnight, where the activity levels are divided in light (LPA), moderate (MPA) and vigorous (VPA) intensity.
Accelerometers of the same type have been used in the population-based health examination study FinHealth 2017 Survey, providing us with a meaningful reference when interpreting the data.
Before starting intervention (day 0) and after intervention (day 56-60)
Secondary Change in moderate physical activity For objective measurement of amount and quality of activity and sleep, participants kept a wrist worn accelerometer (ActiGraph GT9X Link, Actigraph LLC, Pensacola, Florida, USA). As we are interested in the effects on everyday life, accelerometer data was not collected during the intervention itself, but before starting the program and after the intervention. Data shows the number of active days with the minimum of 10 hours of wear time from midnight-to-midnight, where the activity levels are divided in light (LPA), moderate (MPA) and vigorous (VPA) intensity.
Accelerometers of the same type have been used in the population-based health examination study FinHealth 2017 Survey, providing us with a meaningful reference when interpreting the data.
Before starting intervention (day 0) and after intervention (day 56-60)
Secondary Change in vigorous physical activity For objective measurement of amount and quality of activity and sleep, participants kept a wrist worn accelerometer (ActiGraph GT9X Link, Actigraph LLC, Pensacola, Florida, USA). As we are interested in the effects on everyday life, accelerometer data was not collected during the intervention itself, but before starting the program and after the intervention. Data shows the number of active days with the minimum of 10 hours of wear time from midnight-to-midnight, where the activity levels are divided in light (LPA), moderate (MPA) and vigorous (VPA) intensity.
Accelerometers of the same type have been used in the population-based health examination study FinHealth 2017 Survey, providing us with a meaningful reference when interpreting the data.
Before starting intervention (day 0) and after intervention (day 56-60)
Secondary Change in importance of nature and physical activity Question: Is nature important to you? Likert-like scale:1-5 Before starting intervention (day 0) and after intervention (day 56)
Secondary Change in importance physical activity Question: Is physical exercise important to you? Likert-like scale: 1- 5 Before starting intervention (day 0) and after intervention (day 56)
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