Sun Protection for Florida's Children

June 19, 2012 updated by: Richard Roetzheim, University of South Florida
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Actual)

2984

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Univeristy of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sun Protection Intervention
School based sun protection education, provision of free hats.
Behavioral: 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
No Intervention: Control arm
Usual sun protection practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase the use of hats when children are outside at school
Time Frame: june 2008
june 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase the hat use when children are outside at times other than school
Time Frame: june 2008
june 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA103965-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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