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Sun Protection for Florida's Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346021
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : June 20, 2012
Information provided by (Responsible Party):
Richard Roetzheim, University of South Florida

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).

Condition or disease Intervention/treatment Phase
Skin Cancer Behavioral: Increasing hat use Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2984 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sun Protection for Florida's Children
Study Start Date : February 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: Sun Protection Intervention
School based sun protection education, provision of free hats.
Behavioral: Increasing hat use
Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats

No Intervention: Control arm
Usual sun protection practices

Primary Outcome Measures :
  1. Increase the use of hats when children are outside at school [ Time Frame: june 2008 ]

Secondary Outcome Measures :
  1. Increase the hat use when children are outside at times other than school [ Time Frame: june 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00346021

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United States, Florida
Univeristy of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
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Principal Investigator: Richard G Roetzheim, MD, MSPH Department of Family Medicine, USF

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Richard Roetzheim, Professor of Family Medicine, University of South Florida Identifier: NCT00346021     History of Changes
Other Study ID Numbers: R01CA103965-01 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Richard Roetzheim, University of South Florida:
Children's behavior towards hat use

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Skin Diseases