Skin CancerShadeNCT02971709
Use of Shade in U.S. and Australian City Parks
A study testing Shade Sail in people with Skin Cancer, run by Klein Buendel, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Shade Sail
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2010to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Passive recreation areas where major construction/ redevelopment of the parks was planned within the study period.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- Shade Sail
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shade SailBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shade Sail | Experimental | 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. Receives: Behavioral: Shade Sail |
| Unshaded Control | No intervention | Passive recreation areas in public parks that remained unshaded at pretest and posttest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One-year
Secondary outcomes (1)
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.
Measured: One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startJul 2010
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Council Victoria
- Responsible party
- Sponsor
- Investigators
- David Buller, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971709
- Sponsor's protocol ID
- CA140367
- Other IDs
- 0265
- Acronym
- Shade
- Status last verified
- Jul 2017
- First submitted
- 21 Nov 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Buller DB, English DR, Buller MK, Simmons J, Chamberlain JA, Wakefield M, Dobbinson S. Shade Sails and Passive Recreation in Public Parks of Melbourne and Denver: A Randomized Intervention. Am J Public Health. 2017 Dec;107(12):1869-1875. doi: 10.2105/AJPH.2017.304071. Epub 2017 Oct 19.
PubMed 29048958
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norms and Built Environment: Use of Shade in U.S. and Australian City Parks
- ClinicalTrials.gov ID
- NCT02971709
- Acronym / sponsor ID
- Shade / CA140367
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Council Victoria
- Study start
- Jul 2010
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shade Sail | Experimental | Behavioral: Shade SailShade 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. |
| Unshaded Control | No intervention | –Passive recreation areas in public parks that remained unshaded at pretest and posttest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Passive recreation areas where major construction/ redevelopment of the parks was planned within the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shade SailShade 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. | Behavioural | Shade Sail |
Primary outcome
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.
1 secondary outcome
Solar Ultraviolet Radiation Level
Time frame: One-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 29048958Buller DB, English DR, Buller MK, Simmons J, Chamberlain JA, Wakefield M, Dobbinson S. Shade Sails and Passive Recreation in Public Parks of Melbourne and Denver: A Randomized Intervention. Am J Public Health. 2017 Dec;107(12):1869-1875. doi: 10.2105/AJPH.2017.304071. Epub 2017 Oct 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Buller, PhD principal investigator
Klein Buendel, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shade Sail in people with Skin Cancer, run by Klein Buendel, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Use of Passive Recreation Area by Adults (time frame: One-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.