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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03199573
Other study ID # STU00205541
Secondary ID
Status Completed
Phase N/A
First received June 23, 2017
Last updated August 17, 2017
Start date July 1, 2017
Est. completion date July 28, 2017

Study information

Verified date August 2017
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The proposed study will assess the current sun safety policies and practices in programs for young children and to determine the willingness of stakeholders to incorporate more protective measures.

The primary hypothesis is that children in Head Start programs, daycare programs, elementary schools, or summer camps are exposed to significant UV radiation throughout the day, and are not adequately protected with sunscreen, hats, or sun-protective clothing. The secondary hypothesis is that these programs value sun safety as an important health behavior, but probably do not have the funding avilable to make it a priority.


Description:

The study aims are:

1. To assess current exposure to sun and UV in programs of children participating in an early childhood educational program.

2. To assess current policies regarding sun protection and sunscreen use in programs for early childhood education.

3. To assess the current attitudes towards sun safety among caregivers and teachers in programs for early childhood education.

4. To explore association of sun protective behaviors with risk factors such as socioeconomic status, per student classroom budget, program setting (i.e. urban, suburban, or rural), race/ethnicity, size of school program, school budget for supplies, and ages of children enrolled in program.

The sample of stakeholders, who will be surveyed, is consistent with samples used in our prior research. A sample size of 250 phone interviews will be adequate to show trends in sun safety policies among early education programs. Power analysis is based on the use of sun protection, our primary outcome. Our preliminary data show that 15% of schools almost always or always schedule outdoor activities to avoid times when the sun was at peak intensity. The sample size required to sensitively detect a 20% difference in using sun protection between those that comply with recommendations and those that do not is 250 respondents assuming an alpha < 0.05 and power >= 0.8 in a two-tailed test on a two-group sample. This sample size will adequately power the study for detecting 30% difference in sun protection use between the two groups.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date July 28, 2017
Est. primary completion date July 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Someone 18 years of age and older, who is a teacher, administrator, aide, or other staff member of a Head Start program, day care program, camp, or elementary school.

- Participants agree to a structured phone interview regarding their program's policies for sun safety, their opinions on certain health behaviors, and the demographics of their student population.

- Participants will be interviewed on the phone and guided through a questionnaire which should take approximately 10 minutes to complete.

Exclusion Criteria:

- Participants who do not know their program's procedures for sun protection will not be able to participate, but may transfer the phone call to another colleague who can answer the questions accurately. Participants without the ability to speak in English will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Demographics Demographics of programs contacted e.g. racial breakdown, socioeconomic status of families served, ages of children in program, setting. 10 minutes
Primary Total daily sun exposure and sunburn of children Total sun exposure per day and number of sunburns sustained at Head Start program, daycare, camp, or school 10 minutes
Secondary Sun safety policies presence of policies in place to protect children from UV exposure e.g. designated time to don sun protective clothing, encouraging parents to apply sunscreen before school, send children with sun hats. 10 minutes
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