SunburnNCT03199573
Hats on Head Start: A A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs
An observational study of Sunburn, run by Northwestern University at 1 site in United States.
Trial summary
The proposed study will assess the current sun safety policies and practices in programs for young children and to determine the willingness of stakeholders to incorporate more protective measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sunburn
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 28 Jul 2017
- Phase
- Observational
- 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
Study population: Teachers, aides, administrators or staff members at Head Start programs, daycares, camps, or schools.
Who may be able to join
- Someone 18 years of age and older, who is a teacher, administrator, aide, or other staff member of a Head Start program, day care program, camp, or elementary school.
- Participants agree to a structured phone interview regarding their program's policies for sun safety, their opinions on certain health behaviors, and the demographics of their student population.
- Participants will be interviewed on the phone and guided through a questionnaire which should take approximately 10 minutes to complete.
Who cannot join
- Participants who do not know their program's procedures for sun protection will not be able to participate, but may transfer the phone call to another colleague who can answer the questions accurately. Participants without the ability to speak in English will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Hats on Head Start: A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs
The proposed study will assess the current sun safety policies and practices in programs for young children and to determine the willingness of stakeholders to incorporate more protective measures.
The primary hypothesis is that children in Head Start programs, daycare programs, elementary schools, or summer camps are exposed to significant UV radiation throughout the day, and are not adequately protected with sunscreen, hats, or sun-protective clothing. The secondary hypothesis is that these programs value sun safety as an important health behavior, but probably do not have the funding avilable to make it a priority.
Read the detailed description
The study aims are:
- To assess current exposure to sun and UV in programs of children participating in an early childhood educational program.
- To assess current policies regarding sun protection and sunscreen use in programs for early childhood education.
- To assess the current attitudes towards sun safety among caregivers and teachers in programs for early childhood education.
- To explore association of sun protective behaviors with risk factors such as socioeconomic status, per student classroom budget, program setting (i.e. urban, suburban, or rural), race/ethnicity, size of school program, school budget for supplies, and ages of children enrolled in program.
The sample of stakeholders, who will be surveyed, is consistent with samples used in our prior research. A sample size of 250 phone interviews will be adequate to show trends in sun safety policies among early education programs. Power analysis is based on the use of sun protection, our primary outcome. Our preliminary data show that 15% of schools almost always or always schedule outdoor activities to avoid times when the sun was at peak intensity. The sample size required to sensitively detect a 20% difference in using sun protection between those that comply with recommendations and those that do not is 250 respondents assuming an alpha < 0.05 and power >= 0.8 in a two-tailed test on a two-group sample. This sample size will adequately power the study for detecting 30% difference in sun protection use between the two groups.
- Conditions
- Sunburn
- Keywords
- sunscreen
- Medical subject headings
- Sunburn
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily sun exposure and sunburn of children
Total sun exposure per day and number of sunburns sustained at Head Start program, daycare, camp, or school
Measured: 10 minutes
Secondary outcomes (1)
Sun safety policies
presence of policies in place to protect children from UV exposure e.g. designated time to don sun protective clothing, encouraging parents to apply sunscreen before school, send children with sun hats.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Jul 2017
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for SunburnStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June Robinson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199573
- Sponsor's protocol ID
- STU00205541
- Status last verified
- Aug 2017
- First submitted
- 23 Jun 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guy GP Jr, Thomas CC, Thompson T, Watson M, Massetti GM, Richardson LC; Centers for Disease Control and Prevention (CDC). Vital signs: melanoma incidence and mortality trends and projections - United States, 1982-2030. MMWR Morb Mortal Wkly Rep. 2015 Jun 5;64(21):591-6.
PubMed 26042651Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.
PubMed 25928283Gandini S, Sera F, Cattaruzza MS, Pasquini P, Picconi O, Boyle P, Melchi CF. Meta-analysis of risk factors for cutaneous melanoma: II. Sun exposure. Eur J Cancer. 2005 Jan;41(1):45-60. doi: 10.1016/j.ejca.2004.10.016.
PubMed 15617990Godar DE, Urbach F, Gasparro FP, van der Leun JC. UV doses of young adults. Photochem Photobiol. 2003 Apr;77(4):453-7. doi: 10.1562/0031-8655(2003)0772.0.co;2.
PubMed 12733658Buller DB, Borland R. Skin cancer prevention for children: a critical review. Health Educ Behav. 1999 Jun;26(3):317-43. doi: 10.1177/109019819902600304.
PubMed 10349571Buller DB, Geller AC, Cantor M, Buller MK, Rosseel K, Hufford D, Benjes L, Lew RA. Sun protection policies and environmental features in US elementary schools. Arch Dermatol. 2002 Jun;138(6):771-4. doi: 10.1001/archderm.138.6.771.
PubMed 12056958Shanklin S, Brener ND, Kann L, Griffin-Blake S, Ussery-Hall A, Easton A, Barrett E, Hawkins J, Harris WA, McManu T; Centers for Disease Control and Prevention (CDC). Youth risk behavior surveillance--selected Steps communities, United States, 2007. MMWR Surveill Summ. 2008 Nov 21;57(12):1-27.
PubMed 19023264Hall HI, Jorgensen CM, McDavid K, Kraft JM, Breslow R. Protection from sun exposure in US white children ages 6 months to 11 years. Public Health Rep. 2001 Jul-Aug;116(4):353-61. doi: 10.1093/phr/116.4.353.
PubMed 12037264Cokkinides V, Weinstock M, Glanz K, Albano J, Ward E, Thun M. Trends in sunburns, sun protection practices, and attitudes toward sun exposure protection and tanning among US adolescents, 1998-2004. Pediatrics. 2006 Sep;118(3):853-64. doi: 10.1542/peds.2005-3109.
PubMed 16950974Buller DB, Cokkinides V, Hall HI, Hartman AM, Saraiya M, Miller E, Paddock L, Glanz K. Prevalence of sunburn, sun protection, and indoor tanning behaviors among Americans: review from national surveys and case studies of 3 states. J Am Acad Dermatol. 2011 Nov;65(5 Suppl 1):S114-23. doi: 10.1016/j.jaad.2011.05.033.
PubMed 22018060Buller DB, Hall JR, Powers PJ, Ellsworth R, Beach BH, Frank CA, Maloy JA, Buller MK. Evaluation of the "Sunny Days, Healthy Ways" sun safety CD-ROM program for children in grades 4 and 5. Cancer Prev Control. 1999 Jun;3(3):188-95.
PubMed 10474766Buller DB, Taylor AM, Buller MK, Powers PJ, Maloy JA, Beach BH. Evaluation of the Sunny Days, Healthy Ways sun safety curriculum for children in kindergarten through fifth grade. Pediatr Dermatol. 2006 Jul-Aug;23(4):321-9. doi: 10.1111/j.1525-1470.2006.00270.x.
PubMed 16918625Hewitt M, Denman S, Hayes L, Pearson J, Wallbanks C. Evaluation of 'Sun-safe': a health education resource for primary schools. Health Educ Res. 2001 Oct;16(5):623-33. doi: 10.1093/her/16.5.623.
PubMed 11675809Giles-Corti B, English DR, Costa C, Milne E, Cross D, Johnston R. Creating SunSmart schools. Health Educ Res. 2004 Feb;19(1):98-109. doi: 10.1093/her/cyg003.
PubMed 15020549Buller DB, Borland R. Public education projects in skin cancer prevention: child care, school, and college-based. Clin Dermatol. 1998 Jul-Aug;16(4):447-59. doi: 10.1016/s0738-081x(98)00018-2. No abstract available.
PubMed 9699057
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hats on Head Start: A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs
- ClinicalTrials.gov ID
- NCT03199573
- Acronym / sponsor ID
- STU00205541
- Conditions
- Sunburn
- Keywords
- sunscreen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 27 Jun 2017 (actual)
- 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.
The proposed study will assess the current sun safety policies and practices in programs for young children and to determine the willingness of stakeholders to incorporate more protective measures.
The primary hypothesis is that children in Head Start programs, daycare programs, elementary schools, or summer camps are exposed to significant UV radiation throughout the day, and are not adequately protected with sunscreen, hats, or sun-protective clothing. The secondary hypothesis is that these programs value sun safety as an important health behavior, but probably do not have the funding avilable to make it a priority.
Detailed description
The study aims are:
- To assess current exposure to sun and UV in programs of children participating in an early childhood educational program.
- To assess current policies regarding sun protection and sunscreen use in programs for early childhood education.
- To assess the current attitudes towards sun safety among caregivers and teachers in programs for early childhood education.
- To explore association of sun protective behaviors with risk factors such as socioeconomic status, per student classroom budget, program setting (i.e. urban, suburban, or rural), race/ethnicity, size of school program, school budget for supplies, and ages of children enrolled in program.
The sample of stakeholders, who will be surveyed, is consistent with samples used in our prior research. A sample size of 250 phone interviews will be adequate to show trends in sun safety policies among early education programs. Power analysis is based on the use of sun protection, our primary outcome. Our preliminary data show that 15% of schools almost always or always schedule outdoor activities to avoid times when the sun was at peak intensity. The sample size required to sensitively detect a 20% difference in using sun protection between those that comply with recommendations and those that do not is 250 respondents assuming an alpha < 0.05 and power >= 0.8 in a two-tailed test on a two-group sample. This sample size will adequately power the study for detecting 30% difference in sun protection use between the two groups.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Teachers, aides, administrators or staff members at Head Start programs, daycares, camps, or schools.
Key inclusion criteria (3 listed)
- Someone 18 years of age and older, who is a teacher, administrator, aide, or other staff member of a Head Start program, day care program, camp, or elementary school.
- Participants agree to a structured phone interview regarding their program's policies for sun safety, their opinions on certain health behaviors, and the demographics of their student population.
- Participants will be interviewed on the phone and guided through a questionnaire which should take approximately 10 minutes to complete.
Key exclusion criteria (1 listed)
- Participants who do not know their program's procedures for sun protection will not be able to participate, but may transfer the phone call to another colleague who can answer the questions accurately. Participants without the ability to speak in English will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total daily sun exposure and sunburn of children
Time frame: 10 minutes
Total sun exposure per day and number of sunburns sustained at Head Start program, daycare, camp, or school
1 secondary outcome
Sun safety policies
Time frame: 10 minutes
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 22 Aug 2017.
- Background: PubMed 26042651Guy GP Jr, Thomas CC, Thompson T, Watson M, Massetti GM, Richardson LC; Centers for Disease Control and Prevention (CDC). Vital signs: melanoma incidence and mortality trends and projections - United States, 1982-2030. MMWR Morb Mortal Wkly Rep. 2015 Jun 5;64(21):591-6.
- Background: PubMed 25928283Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.
- Background: PubMed 15617990Gandini S, Sera F, Cattaruzza MS, Pasquini P, Picconi O, Boyle P, Melchi CF. Meta-analysis of risk factors for cutaneous melanoma: II. Sun exposure. Eur J Cancer. 2005 Jan;41(1):45-60. doi: 10.1016/j.ejca.2004.10.016.
- Background: PubMed 12733658Godar DE, Urbach F, Gasparro FP, van der Leun JC. UV doses of young adults. Photochem Photobiol. 2003 Apr;77(4):453-7. doi: 10.1562/0031-8655(2003)0772.0.co;2.
- Background: PubMed 10349571Buller DB, Borland R. Skin cancer prevention for children: a critical review. Health Educ Behav. 1999 Jun;26(3):317-43. doi: 10.1177/109019819902600304.
- Background: PubMed 12056958Buller DB, Geller AC, Cantor M, Buller MK, Rosseel K, Hufford D, Benjes L, Lew RA. Sun protection policies and environmental features in US elementary schools. Arch Dermatol. 2002 Jun;138(6):771-4. doi: 10.1001/archderm.138.6.771.
- Background: PubMed 19023264Shanklin S, Brener ND, Kann L, Griffin-Blake S, Ussery-Hall A, Easton A, Barrett E, Hawkins J, Harris WA, McManu T; Centers for Disease Control and Prevention (CDC). Youth risk behavior surveillance--selected Steps communities, United States, 2007. MMWR Surveill Summ. 2008 Nov 21;57(12):1-27.
- Background: PubMed 12037264Hall HI, Jorgensen CM, McDavid K, Kraft JM, Breslow R. Protection from sun exposure in US white children ages 6 months to 11 years. Public Health Rep. 2001 Jul-Aug;116(4):353-61. doi: 10.1093/phr/116.4.353.
- Background: PubMed 16950974Cokkinides V, Weinstock M, Glanz K, Albano J, Ward E, Thun M. Trends in sunburns, sun protection practices, and attitudes toward sun exposure protection and tanning among US adolescents, 1998-2004. Pediatrics. 2006 Sep;118(3):853-64. doi: 10.1542/peds.2005-3109.
- Background: PubMed 22018060Buller DB, Cokkinides V, Hall HI, Hartman AM, Saraiya M, Miller E, Paddock L, Glanz K. Prevalence of sunburn, sun protection, and indoor tanning behaviors among Americans: review from national surveys and case studies of 3 states. J Am Acad Dermatol. 2011 Nov;65(5 Suppl 1):S114-23. doi: 10.1016/j.jaad.2011.05.033.
- Background: PubMed 10474766Buller DB, Hall JR, Powers PJ, Ellsworth R, Beach BH, Frank CA, Maloy JA, Buller MK. Evaluation of the "Sunny Days, Healthy Ways" sun safety CD-ROM program for children in grades 4 and 5. Cancer Prev Control. 1999 Jun;3(3):188-95.
- Background: PubMed 16918625Buller DB, Taylor AM, Buller MK, Powers PJ, Maloy JA, Beach BH. Evaluation of the Sunny Days, Healthy Ways sun safety curriculum for children in kindergarten through fifth grade. Pediatr Dermatol. 2006 Jul-Aug;23(4):321-9. doi: 10.1111/j.1525-1470.2006.00270.x.
- Individual participant dataSharing planned: No
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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.
June Robinson, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sunburn, run by Northwestern University at 1 site in United States.
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 3 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Total daily sun exposure and sunburn of children (time frame: 10 minutes). 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 NCT03199573, which also lists 30 linked publications.
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 22 Aug 2017.