- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02971709
Use of Shade in U.S. and Australian City Parks (Shade)
July 24, 2017 updated by: Klein Buendel, Inc.
Norms and Built Environment: Use of Shade in U.S. and Australian City Parks
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.
Study Overview
Detailed Description
This study is designed to understand the value of shade development in skin cancer prevention and test predictions from social ecologic models that health behavior results from the interplay among the built environment, social environment, and setting features.
Use of shade is recommended by health authorities worldwide.
However, shade provision requires expensive physical environment changes and may be effective only when health education has created a social environment (e.g., norms) that motivates its use.
A multi-national research team will explore the use of built shade in passive recreation areas (i.e., areas for sitting/ standing while socializing, preparing/eating a meal, watching/coaching sports, watching a concert, taking a class, or waiting, or areas where people stroll for sightseeing, while observing outdoor displays, or shopping) within public parks and compare use between the United States (i.e., Denver, Colorado) and Australia (i.e., Melbourne, Victoria) to prospectively test the moderating influence of social environment on the built environment.
Pilot studies confirmed that adults in Melbourne had stronger sun protection habits and norms than adults in Denver.
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.The research team will build shade sails at passive recreation areas in public parks and compare use of the passive recreation areas to unshaded passive recreation areas in a randomized pretest-posttest controlled design.
Passive recreation areas will be enrolled in one of three annual sample waves and stratified by location (72 in Denver and 72 in Melbourne).
In each wave, passive recreation areas will be pretested in a first summer, further stratified based on baseline use, and randomized following pretest to construction of a shade sail or an untreated control group in a 1:3 ratio.
Posttesting will occur the following summer, after construction of the shade sails.
In total, 36 passive recreation areas will be randomized to the intervention group with shade sail construction (18 per city) and 108 passive recreation areas to the untreated control group with no shade sails (54 per city).
The primary outcome measure will be use of the passive recreation areas, observed by trained research assistants.
The secondary outcome measure will be the potential ultraviolet radiation exposure, assessed by hand-held meters during the observations of the passive recreation areas.
Data collection will occur during 30-minute periods between 11 am and 3 pm on on 4 weekend days over 20-weeks in the summer.
Primary analyses will be performed on the probability the passive recreation areas are in use when observed and secondary analysis, on estimated standard erythemal dose of ultraviolet radiation during 30 minutes, using intent-to-treat methods.
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Cancer Council Victoria
-
-
-
-
Colorado
-
Golden, Colorado, United States, 80403
- Klein Buendel, Inc.
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Exclusion Criteria:
- Passive recreation areas where major construction/ redevelopment of the parks was planned within the study period.
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
No Intervention: Unshaded Control
Passive recreation areas in public parks that remained unshaded at pretest and posttest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observed Use of Passive Recreation Area by Adults
Time Frame: One-year
|
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.
|
One-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Solar Ultraviolet Radiation Level
Time Frame: One-year
|
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.
|
One-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Buller, PhD, Klein Buendel, Inc.
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
July 1, 2010
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
May 31, 2017
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
November 21, 2016
First Posted (Estimate)
November 23, 2016
Study Record Updates
Last Update Posted (Actual)
July 25, 2017
Last Update Submitted That Met QC Criteria
July 24, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA140367
- 0265 (Other Identifier: Klein Buendel, Inc.)
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 Skin Cancer
-
Abramson Cancer Center at Penn MedicineRecruitingSkin Cancer Face | Skin Cancer ScalpUnited States
-
University of HawaiiVA Palo Alto Health Care SystemCompletedCancer, Other Than Non-melanoma Skin CancerUnited States
-
EnlundCompletedBreast Cancer | Skin Cancer | Colo-rectal CancerSweden
-
Xoft, Inc.Eminence Clinical Research, Inc.CompletedNonmelanoma Skin CancerUnited States
-
National University Hospital, SingaporeNot yet recruitingSkin Cancer | Skin Cancer Prevention | Benign Skin Growth
-
McMaster UniversityRecruitingSkin Cancer, Basal Cell Skin Cancer Skin Cancer, Non-Melanoma Skin Cancers - Squamous Cell Carcinoma Patient SatisfactionCanada
-
SciBase ABRecruitingKeratinocyte Skin CancerGermany
-
Rutgers, The State University of New JerseyCompleted
-
University of MichiganBlue Cross Blue Shield of Michigan FoundationCompletedSkin Cancer PreventionUnited States
-
University of Alabama at BirminghamNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
Clinical Trials on Shade Sail
-
Medical College of WisconsinAmerican Heart AssociationCompletedPreeclampsiaUnited States
-
University of JordanSuspendedDental RestorationJordan
-
Cairo UniversityRecruitingDiscoloration, Tooth | Chip Tooth | Non Vital Teeth | Trauma DentalEgypt
-
Weill Medical College of Cornell UniversityYouV Labs Inc.CompletedSkin Cancer | Actinic Keratoses | Behavior, Health | Ultraviolet-Induced Change in Normal Skin | Behavior, Risk ReductionUnited States
-
University of JordanCompletedPatient Preference | Shade Match | Aesthetic Perception | Teeth ColorJordan
-
Craig HospitalCompleted
-
Cairo UniversityNot yet recruiting
-
Cairo UniversityCompletedAccuracy of Dental Shade Selection in the Aesthetic ZoneEgypt
-
University of MichiganCompleted
-
University of California, Los AngelesCompleted