Sun Protection for Florida's Children - Full Text View

Sponsored by:	University of South Florida
Information provided by:	University of South Florida
ClinicalTrials.gov Identifier:	NCT00346021

Purpose

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	Intervention
Skin Cancer	Behavioral: Increasing hat use

MedlinePlus related topics: Cancer Skin Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Sun Protection for Florida's Children

Further study details as provided by University of South Florida:

Primary Outcome Measures:

Increase the use of hats when children are outside at school

Secondary Outcome Measures:

Increase the hat use when children are outside at times other than school

Estimated Enrollment:	2000
Study Start Date:	February 2005
Estimated Study Completion Date:	May 2006

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:

individual sessions with school principals to facilitate a school policy that encourages hat use when children are outdoors.
sessions with fourth grade teachers that explains the importance of sun protection and hat use, and that addresses potential concerns by teachers.
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.
follow-up sessions in which children are provided free hats with a customized design that represents their school.
sun protection educational materials that are mailed to the parents of targeted children.

Eligibility

Ages Eligible for Study:	8 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346021

Contacts

Contact: Seft Hunter, MA	813-974-2140	shunter@hsc.usf.edu
Contact: Rania Abdulla, BS	813-974-1684 ext 1684	rabdulla@hsc.usf.edu

Locations

United States, Florida
Univeristy of South Florida	Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Richard Roetzheim

Sponsors and Collaborators

University of South Florida

Investigators

Principal Investigator:

Richard G Roetzheim, MD, MSPH

Department of Family Medicine, USF

More Information

Information on the Sun protection Project This link exits the ClinicalTrials.gov site

Study ID Numbers:	Ro1CA 103965-01
Study First Received:	June 27, 2006
Last Updated:	June 27, 2006
ClinicalTrials.gov Identifier:	NCT00346021
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Florida:

Children's behavior towards hat use

Study placed in the following topic categories:

Skin Diseases
Skin Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009