Sun Protection for Florida's Children

NCT ID: NCT00346021

Last Updated: 2012-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2984 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sun Protection Intervention

School based sun protection education, provision of free hats.

Group Type EXPERIMENTAL

Increasing hat use

Intervention Type BEHAVIORAL

Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats

Control arm

Usual sun protection practices

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Richard Roetzheim

Professor of Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard G Roetzheim, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine, USF

Locations

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Univeristy of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22099239 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19686304 (View on PubMed)

Related Links

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http://www.safeplay.org

Information on the Sun protection Project

Other Identifiers

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R01CA103965-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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