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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02971709




Registration number
NCT02971709
Ethics application status
Date submitted
21/11/2016
Date registered
23/11/2016
Date last updated
25/07/2017

Titles & IDs
Public title
Use of Shade in U.S. and Australian City Parks
Scientific title
Norms and Built Environment: Use of Shade in U.S. and Australian City Parks
Secondary ID [1] 0 0
0265
Secondary ID [2] 0 0
CA140367
Universal Trial Number (UTN)
Trial acronym
Shade
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Shade Sail

Experimental: Shade Sail - Shade sails were constructed over passive recreation areas in public parks between pretest and posttest. Shade sails maximized available shade in the passive recreation areas from 11 am to 3 pm in the summer.

No Intervention: Unshaded Control - Passive recreation areas in public parks that remained unshaded at pretest and posttest.


Behaviour: Shade Sail
Shade sails had powder-coated or gout galvanized steel poles and a lighter colored shade cloth to transmit visual light. The shade cloth met Ultraviolet Protection Factor (UPF) ratings to reduce UV under the shade cloth by 94%. The final shade sail designs and sizes were determined with input from parks department staff and complied with all local engineering, building, and planning codes. Shade sails exceeded the minimum safety requirements for strength (for wind and snow load), resistance to light degradation, and UV transmission. The design minimized climbing access points and hazards to adjacent activities.

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Observed Use of Passive Recreation Area by Adults - Any use of each passive recreation, assessed by observing each passive recreation areas for 30 minutes on four weekend days between 11 am and 3 pm when forecast high temperatures were had forecast high temperature were between 72°F/22°C and 95°F/35°C over a 20-week period during two summers (pretest summer, posttest summer) by trained research assistants. Observations were suspended during rain.
Timepoint [1] 0 0
One-year
Secondary outcome [1] 0 0
Solar Ultraviolet Radiation Level - Average potential UV exposure for a user of the passive recreation area assessed in standard erythemal units, based on measurements from a handheld UV meter performed by trained research assistants during assessment of the primary outcome.
Timepoint [1] 0 0
One-year

Eligibility
Key inclusion criteria
- Passive recreation areas had to be located in public parks in Denver, Colorado USA or
Melbourne, Victoria Australia metropolitan area.

- Parks had to contain at least two unshaded PRAs and be administered by the study
municipalities,

- Passive recreation areas had to meet the definition of a passive recreation area,
i.e., areas for sitting/standing while socializing, preparing/eating a meal, watching
or coaching sports, watching a concert, taking a class, or waiting, or areas where
people stroll (walk slowly) for sightseeing while observing outdoor displays (e.g.,
festivals, gardens, zoo exhibits).

- Passive recreation areas had to be in full sun (i.e. no shade) at pretest.

- Passive recreation areas had to contain a space where a shade sail could be
constructed, i.e., free from underground or above ground obstructions, relatively
level, and large enough to accommodate the shade sail.

- Passive recreation areas had to be approved by parks department staff for shade sail
construction.

- Adults had to appear to be 18 years of age or older.

- Adults had to be in the public parks.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Passive recreation areas where major construction/ redevelopment of the parks was
planned within the study period.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Cancer Council Victoria - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Klein Buendel, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Council Victoria
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Use of shade when outdoors is recommended by health authorities worldwide to reduce overall
exposure to ultraviolet radiation. However, expensive physical environment changes are often
required to provide shade and may be effective only when health education has created a
social environment that motivate shade use. A multi-national research team will explore the
use of built shade in passive recreation areas within public parks and compare use of built
shade between the United States and Australia. The specific aims of the project are to: a)
introduce built shade structures (i.e., shade sails) in public parks in Denver and Melbourne;
b) compare the use of passive recreation areas with and without built shade; c) compare the
change in use of the passive recreation areas in Denver and Melbourne after introduction of
built shade, and d) examine the relationship among social environment and physical features
of the environment and built shade.
Trial website
https://clinicaltrials.gov/show/NCT02971709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Buller, PhD
Address 0 0
Klein Buendel, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications