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Sun Protection for Florida's Children

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increasing hat use
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer focused on measuring Children's behavior towards hat use

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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: -

Sites / Locations

  • Univeristy of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sun Protection Intervention

Control arm

Arm Description

School based sun protection education, provision of free hats.

Usual sun protection practices

Outcomes

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

Full Information

First Posted
June 27, 2006
Last Updated
June 19, 2012
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00346021
Brief Title
Sun Protection for Florida's Children
Official Title
Sun Protection for Florida's Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Children's behavior towards hat use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2984 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sun Protection Intervention
Arm Type
Experimental
Arm Description
School based sun protection education, provision of free hats.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Usual sun protection practices
Intervention Type
Behavioral
Intervention Name(s)
Increasing hat use
Intervention Description
Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats
Primary Outcome Measure Information:
Title
Increase the use of hats when children are outside at school
Time Frame
june 2008
Secondary Outcome Measure Information:
Title
Increase the hat use when children are outside at times other than school
Time Frame
june 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard G Roetzheim, MD, MSPH
Organizational Affiliation
Department of Family Medicine, USF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22099239
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.
Results Reference
derived
PubMed Identifier
19686304
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.
Results Reference
derived

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Sun Protection for Florida's Children

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