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NCT Number: NCT05522140

Testing a Nature-based Socila Intevention on Loneliness: the RECETAS-PRG Trial

RECETAS (Re-imagine Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an European project (H2020 No 945095) that aims to reduce loneliness by linking lonely pople to nature-based social actvitities through a group-based intervention.

Background: Loneliness is a person's own perception when his/her need for satisfying social contact and relationships is not met. The feeling of loneliness can be experienced even by a person who is surrounded by people. RECETAS aims to design and test nature-based socila itervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six different citites: Barcelona, Helsinki, Prague, Marseille, Cuenca in Ecuador and Melbourne. If succesful, this will provide an evidence-based approach for using social prescribing to address loneliness.

Objectives: to assess the effectiveness of a 10-week NBSI on loneliness and health-related quality of life in vulnerable people in the area of Prague suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization.

A pilot study was conducted from May to June 2022 prior to the start of the study in January 2023. The main aim of the pilot study was to identify barriers and obstacles to conducting the trial itself.

Methods: The study design is a randomized controlled trial (RCT) including a process evaluation based on Medical health Council guidance, a nested qualitative study and a Health Economics evaluation.

Participants will be recruited mainly from primary care settings (health and social), third sector organisations, community groups, and volunteer organisations. A total of 316 participants will be randomly allocated in two arms after the baseline assessment: NBSI tratment and control arms. All of them will be asked to sign the informed consent form.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles University

Prague, Czechia

About this study

RECETAS (Re-imagine Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is project that adresses loneliness and the role of nature-based social prescription (NBSP) to reduce it. This project has received funding from European Union's Horizon research and innovation under grant agreement No 945094. More information at: https://recetasproject.eu/

Background: Loneliness is a person's own perception when his/her need for satisfying social contact and relationships is not met. The feeling of loneliness can be experienced even by a person who is surrounded by people. Loneliness is a modifiable health condition that is potentially dangerous to health and can reduce people's life span. In Europe, 30 million people European adults frequently felt lonely.

Social prescription is a non-medical approach that aims to connect people with the community through social outdoor activities to improve their wellbeing. NBSP is an intervention where nature-based social activities connect people, places and institutions that form strong social networks and connections. Nature-based activities can facilitate a dynamic process and social interactions and can thus contribute to reducing feelings of loneliness. We will design and test nature-based social intervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six urban areas: Barcelona, Helsinki, Prague, Cuenca in Ecuador and Melbourne.

Objectives: to assess the effectiveness of a 10-week NBSI on loneliness and health-related quality of life in vulnerable people in the area of Prague suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization.

A pilot study was conducted from May to June 2022 prior to the start of the study in January 2023. The main aim of the pilot study was to identify barriers and obstacles to conducting the trial itself.

Methods: A randomized controlled trial (RCT) will be used to assess the effect of NBSI on reducing feelings of loneliness. The RCT will use mixed-method approach collecting qunatitative information to assess the the main outcomes and qualitative methods to explore participant's and professional's experiences. ISGlobal coordinates the overall RECETAS project. Charles University leads the implementation of the RECETAS-PRG and is responsible for the recruitment process, intervention, assessment, evaluation, data analysis and qualitative part of the study.

Recruitment will be carried out in cooperation with the Centre of Longevity and Long-Term Care, the Czech Alzheimer's Society, general practitioners and other outpatient specialists, and home care organizations based on a long-term focus on the target group. Participants will be recruited mainly from primary care settings (health and social), third sector organisations, community groups, and volunteer organisations. A total of 316 participants will be randomly allocated in two arm (158 each): NBSP intervention arm and control arm. All of them will be asked to sign the informed consent form.

The intervention is a theory-informed, multicomponent, multi-level, behaviorally based complex intervention that requires a specific trainning to prepare facilitators. The intervention model is adapted from the "Circle of Friends" methodology developed by the University of Helsinky by Pitkälä KH et al. It consists in: a) individualized session with facilitators (one-to-one); b) group-based program (5-15 people) for 9 sessions, one a wiil, including nature-based activities in the area chosen by the participants. Control group participants will recieve usual care, and list of natrure-based activities available ti their area.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to give informed consent in Czech
  • Older adults (60+) with a risk of social isolation and loneliness
  • Currently experiencing loneliness according to the screening question "Do you suffer from loneliness?"
  • Willing to undergo study measurement.

Exclusion criteria

  • Unable to go outdoors due to poor mobility or severe diseases.
  • Poor hearing or sight in case it prevents them to participate of the group dynamics and activities in the nature.
  • Severe, moderate or mild cognitive decline.
  • Any mental health disorders that might interfere with the group dynamics.
  • Severe disease with poor prognosis < 6 months.

Treatment and study plan

Nature-based social intervention (NBIS)

Behavioral

Nature-based social prescribing is a multicomponent, multi-level, behaviorally based complex intervention applaied by facilitators after a specific training. It comprises: a psychosocial component and nature-based activities. The psychosocial component is adapted from the group dynamic of "Circle of Friends" methodolgy focused on loneliness(Jansson A, Pitkälä KH, 2021) adapted to the cultural context of Prague and the target population (partitipants) of adults who lives in Prague. Participants start with an individual session and then meet once a week for two hours for 10 weeks.

At the first meeting together, participants select the nature-based activities they wish to conduct through a co-created menu.

Usual care + menu with nature based activities

Behavioral

Social prescribing as existing in usual care plus a written menu with the list of nature-based activities in the area.

Primary outcomes

  1. De Jong Gierveld Loneliness Scale 11 item

    Time frame: Post-intervention (10 weeks)

    Change in loneliness. De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))

  2. 15D instrument of health-related quality of life

    Time frame: Post-intervention (10 weeks)

    Change in health related quality of life. Minimum 0 (worst) and maximum 1 (best). 15D will be used as an index ( 0 to 1) and the changes in various 15 dimensions will also be explored.

Secondary outcomes

  1. Psychological Wellbeing Scale by Routasalo et al. 2009

    Time frame: From baseline to 3months, 6months, 12 months

    Change in psychological wellbeing.Minimum 0 (worst) and maximum 1 (best).

  2. Clock drawing test

    Time frame: From baseline to 3months, 6months, 12 months

    Change in executive function. Minimum 0 (worst) and maximum 6 (best)

  3. Instrumental Activities of Daily Living Scale

    Time frame: From baseline to 3months, 6months, 12 months

    Change in instrumental activities of daily living. Minimum 0 (worst) and maximum 10 (best)

  4. 15D instrument of health-related quality of life

    Time frame: Baseline (before intervention), 6- and 12-months follow up

    Change in health related quality of life. Minimum 0 (worst) and maximum 1 (best). 15D will be used as an index ( 0 to 1) and the changes in various 15 dimensions will also be explored.

  5. De Jong Gierveld Loneliness Scale 11 item

    Time frame: Baseline (before intervention), 6- and 12-months follow up

    Change in loneliness. De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))

  6. International Physical Activity Questionnaire

    Time frame: From baseline to 3months, 6months, 12 months

    Change in physical activity. Minimum 1 (worst) and maximum 3 (best)

  7. Geriatric Depression Scale

    Time frame: From baseline to 3months, 6months, 12 months

    Change in depression. Minimum 0 (best) and maximum 15 (worst)

  8. Lubben Social Network Scale

    Time frame: From baseline to 3months, 6months, 12 months

    Change in social network. Minimum 0 (worst) and maximum 5 (best)

  9. EURO-QOL 5D-5L

    Time frame: From baseline to 3months, 6months, 12 months

    Health economic analyses. Cost of health services with EQ5D-5L

  10. ICEpop CAPability mesure for Adults (ICECAP-A)

    Time frame: From baseline to 3months, 6months, 12 months

    Self-reported measure of capability wellbeing for adults

  11. Nature connection index

    Time frame: From baseline to 3months, 6months, 12 months

    Relationship with nature. Min = 1 Max = 7. Higher scores indicating stronger connectedness to nature

Sponsors and collaborators

Lead sponsor

Vladimíra Dostálová

Other

Collaborators

  • Barcelona Institute for Global Health

Registry information

Official study title

Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Prague - a Randomized Controlled Trial

Acronym: RECETAS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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