PHENOTYPE. Therapeutic Study in Barcelona

April 26, 2018 updated by: Mark Nieuwenhuijsen, Barcelona Institute for Global Health

Positive Health Effects of the Natural Outdoor Environment in Typical Populations in Different Regions in Europe. Work Package 4: Therapeutic Study in Barcelona

The study aimed to explore therapeutic effects of natural environments. To do so, the investigators evaluated the immediate and sustained changes in several indicators of well-being while people (n=26) with poor mental health were engaged in unconstrained exposures to natural (green, blue) and urban environments. The indicators included: affection, cognition, physiological responses.

Each participant was exposed to all environments for a period of 210 minutes between October 2013 and January 2014. During the exposure period, participants were instructed to do what they would usually do in that environment. Before, during (at 30 and 210 minutes) and after each exposure, several psycho-physiological measures were taken: (i) heart rate variability and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure monitor, (iii) physical activity using the CalFIT application installed in a Smartphone, (iv) lung function using a portable computerized spirometer, (v) stress level using salivary cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social interactions using questionnaires, (vii) cognitive functioning using the backwards digit-span task test.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the participants (n=26) were individuals that had previously participated in a survey of 1000 people in Barcelona city as part of the PHENOTYPE project. As part of the survey, they had answered the Mental Health Inventory (MHI-5) subscale from the SF-36 health questionnaire. The investigators purposively selected those individuals MHI-5 scored in the lower 50th percentile.

Description

Inclusion Criteria:

  • MHI-5 scored in the lower 50th percentile of the Barcelona city PHENOTYPE sample
  • willing to participate

Exclusion Criteria:

  • no able to walk for 30 minutes at self-directed pace.
  • with chest, abdomen surgery or heart attack during the last three months.
  • with retinal detachment or eyes surgery or hospitalized for heart problem during the last month.
  • with tuberculosis treatment, or respiratory infection during the last three weeks.
  • being asthmatic or pregnant
  • using inhaler the 24 hours previous to the study day.
  • taking medication different from the usual the 24 hours previous to the study day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline heart rate variability at 30 min
Time Frame: after 30 minutes of exposure to green/blue/urban environment
after 30 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate at 30 min
Time Frame: after 30 minutes of exposure to green/blue/urban environment
after 30 minutes of exposure to green/blue/urban environment
Change from blood pressure at 30min
Time Frame: after 30 minutes of exposure to green/blue/urban environment
after 30 minutes of exposure to green/blue/urban environment
Change from stress level at 30min (salivary cortisol)
Time Frame: after 30 of exposure to green/blue/urban environment
after 30 of exposure to green/blue/urban environment
Change from affect at 30 min (BRUMS/POMS)
Time Frame: after 30 minutes of exposure to green/blue/urban environment
after 30 minutes of exposure to green/blue/urban environment
Change from cognitive functioning at 30 min (backward digit span task)
Time Frame: after 30 minutes of exposure to green/blue/urban environment
after 30 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate variability at 210 min
Time Frame: after 210 minutes of exposure to green/blue/urban environment
after 210 minutes of exposure to green/blue/urban environment
Change from Baseline heart rate at 210 min
Time Frame: after 210 minutes of exposure to green/blue/urban environment
after 210 minutes of exposure to green/blue/urban environment
Change from blood pressure at 210min
Time Frame: after 210 minutes of exposure to green/blue/urban environment
after 210 minutes of exposure to green/blue/urban environment
Change from stress level at 210min (salivary cortisol)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
after 210 minutes of exposure to green/blue/urban environment
Change from affect at 210 min (BRUMS/POMS)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
after 210 minutes of exposure to green/blue/urban environment
Change from cognitive functioning at 210 min (backward digit span task)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
after 210 minutes of exposure to green/blue/urban environment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objectively measured physical activity 30
Time Frame: During the first 30 minutes of exposure to green/blue/urban environment
Measured with a Smartphone application (CalFIT)
During the first 30 minutes of exposure to green/blue/urban environment
perceived restoration 30 (ROS - Korpela's Restoration outcome scale)
Time Frame: after 30 minutes of exposure to green/blue/urban environment
after 30 minutes of exposure to green/blue/urban environment
subjectively recorded social interactions 30
Time Frame: after 30 minutes of exposure to green/blue/urban environment
Measurement tool developed by the research team
after 30 minutes of exposure to green/blue/urban environment
ambient air pollution exposure 30 (PM2.5)
Time Frame: During the first 30 minutes of exposure to green/blue/urban environment
Measured with MicroAthelometer
During the first 30 minutes of exposure to green/blue/urban environment
objectively measured physical activity 210
Time Frame: During the first 210 minutes of exposure to green/blue/urban environment
Measured with a Smartphone application (CalFIT)
During the first 210 minutes of exposure to green/blue/urban environment
perceived restoration 210 (ROS- Korpela's Restoration outcome scale)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
after 210 minutes of exposure to green/blue/urban environment
subjectively recorded social interactions 210
Time Frame: after 210 minutes of exposure to green/blue/urban environment
Measurement tool developed by the research team
after 210 minutes of exposure to green/blue/urban environment
ambient air pollution exposure 210 (PM2.5)
Time Frame: During the first 210 minutes of exposure to green/blue/urban environment
Measured with MicroAthelometer
During the first 210 minutes of exposure to green/blue/urban environment
personal air pollution (CO, NO, NO2)
Time Frame: During all the data collection day
Personal sensors designed and built at Cambridge University, UK (CamPerS)
During all the data collection day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PHENOTYPE_WP4BCN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Poor Mental Health

Clinical Trials on There was no intervention.

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