Sun Protection for Florida's Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Roetzheim, University of South Florida
ClinicalTrials.gov Identifier:
NCT00346021
First received: June 27, 2006
Last updated: June 19, 2012
Last verified: June 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sun Protection for Florida's Children

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Increase the use of hats when children are outside at school [ Time Frame: june 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Increase the hat use when children are outside at times other than school [ Time Frame: june 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 2984
Study Start Date: February 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Univeristy of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Richard G Roetzheim, MD, MSPH Department of Family Medicine, USF
  More Information

Additional Information:
No publications provided by University of South Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Roetzheim, Professor of Family Medicine, University of South Florida
ClinicalTrials.gov Identifier: NCT00346021     History of Changes
Other Study ID Numbers: Ro1CA 103965-01
Study First Received: June 27, 2006
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Children's behavior towards hat use

ClinicalTrials.gov processed this record on October 23, 2014