Clinical trial NCT03199573: Hats on Head Start: A A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs
Official title: Hats on Head Start: A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sunburn
Keywords: sunscreen
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teachers, aides, administrators or staff members at Head Start programs, daycares, camps, or schools.

Brief 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.

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:

1. To assess current exposure to sun and UV in programs of children participating in an early childhood educational program.
2. To assess current policies regarding sun protection and sunscreen use in programs for early childhood education.
3. To assess the current attitudes towards sun safety among caregivers and teachers in programs for early childhood education.
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Total daily sun exposure and sunburn of children
timeFrame: 10 minutes
Secondary outcomes:
measure: Sun safety policies
timeFrame: 10 minutes
Other outcomes:
measure: Demographics
timeFrame: 10 minutes
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: June Robinson, MD
role: PRINCIPAL_INVESTIGATOR
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