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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Barcelona Institute for Global Health

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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