NCT02376517

Brief Summary

The purpose of this study is to test the effectiveness of a sun protection education program for children of all ethnic and racial backgrounds. Practicing sun protection in childhood can reduce the likelihood of developing skin cancer as an adult. The educational program consists of a read-along book in English and Spanish for the child to read with the parent or caregiver, text message reminders to practice sun protection, and a sun protective swim shirt for the child.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

February 20, 2015

Last Update Submit

September 16, 2015

Conditions

ChildrenParentsSun Protection

Keywords

Health BehaviorMelanin IndexSpectrophotometrySun Protective ClothingEducationPrimary Prevention

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Melanin Index at 4-6 weeks

    The use of sun protection in those receiving the intervention versus the control group will be examined for correlation with melanin index of child's arm at the baseline and 4-6 week follow-up visit. Spectrophotometer measurement is the wavelength of the reflected light measured in nm. It represents the area under the curve for the all wavelengths of light, thus a reading will be expressed as (192 ±30, mean ± SD).

    Baseline and 4-6 Weeks

Study Arms (2)

Educational program

ACTIVE COMPARATOR

Participants randomized to the intervention group will receive the educational program at the baseline visit.

Behavioral: Educational program

Control

NO INTERVENTION

Participants randomized to the control group will receive the educational program at the follow-up visit.

Interventions

Educational programBEHAVIORAL

The educational program consists of a short (13 pages) read-along book in English and Spanish. This book presents sun protective practices at an appropriate level for 2-6 year old children to read with their parent or caregiver. A sun protective swim shirt, which provides a sun-protection factor (SPF) of over 50, for the child will be provided. Additionally, the parent will receive weekly text message reminders to practice sun protection.

Educational program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are at least 18 years old
  • Is the parent of a 2-6 year old child attending a well-child visit
  • If the parent present is female, she may be pregnant
  • Are able to read in English and/or Spanish at a 6th grade level or higher
  • Are able to receive text messages

You may not qualify if:

  • Is the parent of a child less than 2 or older than 6 years old attending a visit
  • Unable to read in English and/or Spanish at a 6th grade level or higher
  • Unable to receive text messages
  • Unable to complete study procedures with eligible child
  • Unable to return to clinic for a follow-up visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Advocate Medical Group - Pediatric Clinics

Park Ridge, Illinois, 60068, United States

Location

Related Publications (1)

  • Ho BK, Reidy K, Huerta I, Dilley K, Crawford S, Hultgren BA, Mallett KA, Turrisi R, Robinson JK. Effectiveness of a Multicomponent Sun Protection Program for Young Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):334-42. doi: 10.1001/jamapediatrics.2015.4373.

    PMID: 26857829DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • June K Robinson, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 3, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

US(2)