Clinical trial NCT00346021: Sun Protection for Florida's Children
Official title: Sun Protection for Florida's Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: Children's behavior towards hat use
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2006-06-29
Enrollment: 2984
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose of the project is to develop a school-based intervention aimed at increasing hat use when children are outside at home and at school. The intervention is targeted to fourth grade children in Hillsborough County, Florida and is based on Theory of Reasoned Action and Planned Behavior. It is structured to accomplish the following goals: (a) increase sun protection knowledge of children in regards to hat use,(b) foster more positive attitudes in regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons that children perceive as controlling their behavior of wearing hats(parents,teachers) and increase the use of hats when children are outdoors at school(primary outcome) and when outdoors at times other than school(secondary outcome).

Detailed description: Intervention is aimed at encouraging students to use a wide brim hat when participating in outdoor activities. To accomplish this goal our approach will be multifaceted and will include:

1. individual sessions with school principals to facilitate a school policy that encourages hat use when children are outdoors.
2. sessions with fourth grade teachers that explains the importance of sun protection and hat use, and that addresses potential concerns by teachers.
3. classroom sessions with fourth grade children that improves sun protection knowledge, fosters more positive attitudes about hat use. and that changes the subjective norm of wearing hats when at school.
4. follow-up sessions in which children are provided free hats with a customized design that represents their school.
5. sun protection educational materials that are mailed to the parents of targeted children.

Eligibility criteria: Inclusion Criteria:

* One fourth/one fifth grade class.
* 20 students minimum.
* 25% of students are Caucasian.
* Principle/teachers agree to participate.
* Majority of parents agree to participate.
* Majority of 4th grade students provide written assent.
* One outdoor session lasting 20 minutes once per week where children are directly exposed to the sun.
* Outdoor session in an area observable by data monitors.
* School can accommodate intervention components of study.
* School environment stable over the intervention period.
* Randomized control school delay sun protection initiatives until project is completed.

Exclusion Criteria:

-

Primary outcomes:
measure: Increase the use of hats when children are outside at school
timeFrame: june 2008
Secondary outcomes:
measure: Increase the hat use when children are outside at times other than school
timeFrame: june 2008
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Univeristy of South Florida
state: Florida
Study officials:
affiliation: Department of Family Medicine, USF
name: Richard G Roetzheim, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roetzheim RG, Love-Jackson KM, Hunter SG, Lee JH, Chen R, Abdulla R, Wells KJ. A cluster randomized trial of sun protection at elementary schools. Results from year 2. Am J Prev Med. 2011 Dec;41(6):615-8. doi: 10.1016/j.amepre.2011.08.005.
citation: Hunter S, Wells KJ, Jacobsen PB, Lee JH, Boulware D, Love-Jackson K, Abdulla R, Roetzheim RG. Assessment of elementary school students' sun protection behaviors. Pediatr Dermatol. 2010 Mar-Apr;27(2):182-8. doi: 10.1111/j.1525-1470.2009.00940.x. Epub 2009 Jul 20.