NCT00346021

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,984

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

6.5 years

First QC Date

June 27, 2006

Last Update Submit

June 19, 2012

Conditions

Skin Cancer

Keywords

Children's behavior towards hat use

Outcome Measures

Primary Outcomes (1)

  • Increase the use of hats when children are outside at school

    june 2008

Secondary Outcomes (1)

  • Increase the hat use when children are outside at times other than school

    june 2008

Study Arms (2)

Sun Protection Intervention

EXPERIMENTAL

School based sun protection education, provision of free hats.

Behavioral: Increasing hat use

Control arm

NO INTERVENTION

Usual sun protection practices

Interventions

Increasing hat useBEHAVIORAL

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

Sun Protection Intervention

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • One fourth/one fifth grade class.
  • students minimum.
  • % 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (2)

  • 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.

    PMID: 22099239DERIVED

  • 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.

    PMID: 19686304DERIVED

Related Links

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Richard G Roetzheim, MD, MSPH

    Department of Family Medicine, USF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Family Medicine

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

February 1, 2005

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

US(1)