PHENOTYPE. Therapeutic Study in Barcelona

NCT02624921 | Completed

• 1 other identifier: PHENOTYPE_WP4BCN
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Poor Mental Health; Natural Outdoor Environments

Outcome Measures

Primary Outcomes (12)

• Change from Baseline heart rate variability at 30 min

  after 30 minutes of exposure to green/blue/urban environment

• Change from Baseline heart rate at 30 min

  after 30 minutes of exposure to green/blue/urban environment

• Change from blood pressure at 30min

  after 30 minutes of exposure to green/blue/urban environment

• Change from stress level at 30min (salivary cortisol)

  after 30 of exposure to green/blue/urban environment

• Change from affect at 30 min (BRUMS/POMS)

  after 30 minutes of exposure to green/blue/urban environment

• Change from cognitive functioning at 30 min (backward digit span task)

  after 30 minutes of exposure to green/blue/urban environment

• Change from Baseline heart rate variability at 210 min

  after 210 minutes of exposure to green/blue/urban environment

• Change from Baseline heart rate at 210 min

  after 210 minutes of exposure to green/blue/urban environment

• Change from blood pressure at 210min

  after 210 minutes of exposure to green/blue/urban environment

• Change from stress level at 210min (salivary cortisol)

  after 210 minutes of exposure to green/blue/urban environment

• Change from affect at 210 min (BRUMS/POMS)

  after 210 minutes of exposure to green/blue/urban environment

• Change from cognitive functioning at 210 min (backward digit span task)

  after 210 minutes of exposure to green/blue/urban environment

Secondary Outcomes (9)

• objectively measured physical activity 30

  During the first 30 minutes of exposure to green/blue/urban environment

• perceived restoration 30 (ROS - Korpela's Restoration outcome scale)

  after 30 minutes of exposure to green/blue/urban environment

• subjectively recorded social interactions 30

  after 30 minutes of exposure to green/blue/urban environment

• ambient air pollution exposure 30 (PM2.5)

  During the first 30 minutes of exposure to green/blue/urban environment

• objectively measured physical activity 210

  During the first 210 minutes of exposure to green/blue/urban environment

Interventions

There was no intervention. OTHER

Participants were transported one day to a urban setting, one day to a green space, one day to a beach. No intervention was done.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead

Related Publications (1)

• 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.

  PMID: 28248974 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Air Pollution and Urban Environment program coordinator

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 9, 2015
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 27, 2018

Record last verified: 2018-04