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Clinical Trials/NCT02177006
NCT02177006CompletedNot Applicable

Helping Children be Safe Outdoors With Sun Protection

Northwestern University1 site in 1 country840 target enrollmentStarted: June 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
840
Locations
1
Primary Endpoint
Number of completed caregiver self-reported surveys

Study Overview

Brief Summary

Childhood exposure to high levels of sunlight is a strong determinant of melanoma risk. Pediatric clinicians can provide important sun protection counseling. In 2003, the United States Preventive Services Task Force determined that clinician counseling has an effect on use of sunscreen for children but not for other sun protection measures such as protective clothing, or reducing sun exposure. Regular sunscreen use prevents melanoma development in adults as well as nevi in children, but reliance on sunscreen as the only form of sun protection is problematic.

This novel research seeks to develop a sun protection program that is feasible for pediatric clinicians to deliver with patient-centered messages and systems to support program implementation in the clinical offices. The sun protection messages will enable behavioral change by the stakeholders (caregivers and children) that will reduce painful sunburns in the children and eventually reduce the incidence of melanoma. Testing the feasibility of delivering the intervention in a pediatric practice will enhance the sustainability of the intervention, and lead the way to dissemination of good practice.

This proposal seeks to develop and test an intervention that seeks to improve sun protection of young children. The intervention includes two phases:

Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory guidance sheet provided by the practice to caregivers of children 2-6 years of age.

Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported surveys

We hypothesize that redemption of the vouchers will be associated with the perception of the child having sun sensitive skin.

Detailed Description

Phase 1:

The Lake Forest Pediatric Associates with pediatricians and nurse practitioners in Lake Bluff, IL, Lindenhurst, IL and Vernon Hills, IL have agreed to participate in the research. All members of this practice have appointments in the Department of Pediatrics at Northwestern Lake Forest Hospital.

We seek to test the feasibility of delivering the sun protection message by affixing vouchers to redeem a swim shirt to the sun protection tip sheet that will be delivered to the caregiver by the practitioners.

As part of the well child visit performed by the pediatric clinicians from Lake Forest Pediatric Associates, caregivers of children from 2-6 years old will receive a tip sheet with a voucher during the 13 weeks from June 1, 2014 until August 31, 2014. The research manager will be present at the clinic on pre-designated dates and times, during which she will be responsible for replenishing the research packet consisting of vouchers, tip sheet and survey, recording the numbers of the packets distributed in the prior week, and collecting the completed surveys.

Phase 2:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of completed caregiver self-reported surveys

Time Frame: Baseline

Secondary Outcomes

  • Percentage of online redemption of swim shirt vouchers in comparison with the caregiver self-reported surveys(Baseline, up to 13 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

June Robinson

MD, Professor of Dermatology

Northwestern University

Study Sites (1)

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