Clinical trial NCT02624921: PHENOTYPE. Therapeutic Study in Barcelona
Official title: Positive Health Effects of the Natural Outdoor Environment in Typical Populations in Different Regions in Europe. Work Package 4: Therapeutic Study in Barcelona
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poor Mental Health
Natural Outdoor Environments
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline heart rate variability at 30 min
timeFrame: after 30 minutes of exposure to green/blue/urban environment
measure: Change from Baseline heart rate at 30 min
timeFrame: after 30 minutes of exposure to green/blue/urban environment
measure: Change from blood pressure at 30min
timeFrame: after 30 minutes of exposure to green/blue/urban environment
measure: Change from stress level at 30min (salivary cortisol)
timeFrame: after 30 of exposure to green/blue/urban environment
measure: Change from affect at 30 min (BRUMS/POMS)
timeFrame: after 30 minutes of exposure to green/blue/urban environment
measure: Change from cognitive functioning at 30 min (backward digit span task)
timeFrame: after 30 minutes of exposure to green/blue/urban environment
measure: Change from Baseline heart rate variability at 210 min
timeFrame: after 210 minutes of exposure to green/blue/urban environment
measure: Change from Baseline heart rate at 210 min
timeFrame: after 210 minutes of exposure to green/blue/urban environment
measure: Change from blood pressure at 210min
timeFrame: after 210 minutes of exposure to green/blue/urban environment
measure: Change from stress level at 210min (salivary cortisol)
timeFrame: after 210 minutes of exposure to green/blue/urban environment
measure: Change from affect at 210 min (BRUMS/POMS)
timeFrame: after 210 minutes of exposure to green/blue/urban environment
measure: Change from cognitive functioning at 210 min (backward digit span task)
timeFrame: after 210 minutes of exposure to green/blue/urban environment
Secondary outcomes:
measure: objectively measured physical activity 30
timeFrame: During the first 30 minutes of exposure to green/blue/urban environment
measure: perceived restoration 30 (ROS - Korpela's Restoration outcome scale)
timeFrame: after 30 minutes of exposure to green/blue/urban environment
measure: subjectively recorded social interactions 30
timeFrame: after 30 minutes of exposure to green/blue/urban environment
measure: ambient air pollution exposure 30 (PM2.5)
timeFrame: During the first 30 minutes of exposure to green/blue/urban environment
measure: objectively measured physical activity 210
timeFrame: During the first 210 minutes of exposure to green/blue/urban environment
measure: perceived restoration 210 (ROS- Korpela's Restoration outcome scale)
timeFrame: after 210 minutes of exposure to green/blue/urban environment
measure: subjectively recorded social interactions 210
timeFrame: after 210 minutes of exposure to green/blue/urban environment
measure: ambient air pollution exposure 210 (PM2.5)
timeFrame: During the first 210 minutes of exposure to green/blue/urban environment
measure: personal air pollution (CO, NO, NO2)
timeFrame: During all the data collection day
Other outcomes:
Locations:
Study officials:
References:
citation: Triguero-Mas M, Gidlow CJ, Martinez D, de Bont J, Carrasco-Turigas G, Martinez-Iniguez T, Hurst G, Masterson D, Donaire-Gonzalez D, Seto E, Jones MV, Nieuwenhuijsen MJ. The effect of randomised exposure to different types of natural outdoor environments compared to exposure to an urban environment on people with indications of psychological distress in Catalonia. PLoS One. 2017 Mar 1;12(3):e0172200. doi: 10.1371/journal.pone.0172200. eCollection 2017.