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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Educational/Counseling/Training, Prevention Active 8 to 11 Other Ro1CA 103965-01 NCT00346021

Trial Description

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).

Further Study Information

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:

Trial Contact Information

Trial Lead Organizations/Sponsors

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Richard G Roetzheim, MD, MSPH

Principal Investigator

Seft Hunter, MA		Ph: 813-974-2140
		Email: shunter@hsc.usf.edu

Rania Abdulla, BS		Ph: 813-974-1684 Ext.1684
		Email: rabdulla@hsc.usf.edu

U.S.A.
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Richard Roetzheim	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00346021
Information obtained from ClinicalTrials.gov on May 27, 2008