NCT05893212

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

May 15, 2023

Last Update Submit

May 30, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (9)

  • Change in total sleep time

    Before starting intervention (day 0) and after intervention (day 56-60)

  • Change in time in bed.

    Before starting intervention (day 0) and after intervention (day 56-60)

  • Change in sleep efficiency

    Before starting intervention (day 0) and after intervention (day 56-60)

  • Change in number and length of awakenings after sleep onset

    Before starting intervention (day 0) and after intervention (day 56-60)

  • Change in light physical activity

    Before starting intervention (day 0) and after intervention (day 56-60)

  • +4 more secondary outcomes

Study Arms (2)

Nature-group

EXPERIMENTAL

Primary care patients identified to be in the target group for health promoting activity by health or social service professionals. Participants chose to take part in the 8 week nature-group, meeting weekly in outdoor areas.

Behavioral: Nature based facilitated group intervention

Sports-group

ACTIVE COMPARATOR

Primary care patients identified to be in the target group for health promoting activity by health or social service professionals. Participants chose to take part in the 8 week sports-group, meeting weekly in community sports facilities.

Behavioral: Exercise in group

Interventions

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.

Nature-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.

Sports-group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sipoo Social and Health center

Sipoo, Itä-Uusimaa, 04130, Finland

Location

Related Publications (1)

  • Kolster A, Heikkinen M, Pajunen A, Mickos A, Wennman H, Partonen T. Targeted health promotion with guided nature walks or group exercise: a controlled trial in primary care. Front Public Health. 2023 Aug 24;11:1208858. doi: 10.3389/fpubh.2023.1208858. eCollection 2023.

Related Links

MeSH Terms

Interventions

ExercisePopulation Groups

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDemographyPopulation Characteristics

Study Officials

  • Timo Partonen, MD, PhD

    Research professor at Finnish Institute for Health and Welfare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Care provider recommended participation in either group, based on discussion with participant. All data is anonymized and stored at the Finnish Institute for Health and Welfare and outcomes assessor has access to this data, however, it includes knowledge of group participation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a controlled pilot study on parallel groups in a real life, intention-to-treat setting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral researcher

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 7, 2023

Study Start

March 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

According to the original research permission granted by the Finnish Institute for Health and Welfare all data is anonymized and stored at the institute, only accessible to researchers with permission from the institute.

Locations