Sun Protection for Florida's Children

Skin Cancer Clinical Trial

Official title:

Sun Protection for Florida's Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346021
• Other study ID #: Ro1CA 103965-01
• Status: Completed
• Phase: N/A
• First received: June 27, 2006
• Last updated: June 19, 2012
• Start date: February 2005
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2984
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Skin Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Univeristy of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase the use of hats when children are outside at school		june 2008	Yes
Secondary	Increase the hat use when children are outside at times other than school		june 2008	Yes

External Links

•   Information on the Sun protection Project