Healia Clinical Trials Information Database

Sun Protection for Florida's Children

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).

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.

Status: Recruiting (N/A). Started on February 1st, 2005.

Enrollment: 2000 subjects

Study Type: Interventional

Study Design:

  • Allocation: Randomized
  • Endpoint Classification: Efficacy Study
  • Intervention Model: Factorial Assignment
  • Masking: Open Label

Conditions:

Interventions:

  • Behavioral: Increasing hat use

Eligibility

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:

-

Gender

Both

Mininum Age

8 Years

Maximum Age

11 Years

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: University of South Florida

Authority: United States: Institutional Review Board

Locations

  • Univeristy of South Florida
    Tampa
    Florida
    33612
    United States

Officials

  • Richard G Roetzheim, MD, MSPH (Principal Investigator, Department of Family Medicine, USF)

Sponsors

  • University of South Florida (Lead Sponsor)

References

None.

Links


Date Verified
January 1st, 2009
First Received
August 5th, 2010
Last Changed
August 5th, 2010

Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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