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Completed

NCT Number: NCT01804595

A Randomized Control Trial of Sun Protection Interventions for Operating Engineers

This is a randomized controlled trial testing the efficacy of 4 sun protection interventions--education only; education and mailed sunscreen; education and text message reminders; and education, mailed sunscreen, and text message reminders--among Michigan Operating Engineers. Pre- and post-intervention surveys will be collected to determine changes in sunscreen use and sun burning, the primary outcome variables. The investigators hypothesize that all interventions will increase sunscreen use and reduce burning and that the education-only intervention will have the least effect of the 4 interventions while the education, mailed sunscreen, and text messaging arm will have the greatest effect.

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Key information

Conditions

Skin Cancer Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

About this study

The education intervention will be provided during regularly scheduled safety training sessions, and the text messages and mailed sun screen (SPF30)interventions will be offered during the summer when UV rays are at their highest. Inclusion criteria are Operating Engineers who:1)are greater than 18 years of age; 2) are interested in enrolling in the sun protection study; 3) own a cell-phone that accepts text messages; and 4) are willing to share their phone number with the study team. Based on power analysis, 256 subjects are needed to have 80% power to detect medium sized effects on primary outcomes. Accounting for a 20% attrition rate, 320 subjects will be recruited. The analyses will include: a) paired t-tests to determine changes over time (from pre-intervention to post-intervention) in outcome variables (sunscreen use and burning) separately in the 4 intervention groups, b) Repeated Measures Analysis of Variance (RM-ANOVA) to compare the changes in outcomes across the 4 groups, and c) t-tests on change scores as follow-ups to the RM-ANOVA to determine exactly which groups differ from each other. Sub-analyses will explore if particular subgroups of Operating Engineers (e.g., demographic, heath behavior, and job type subgroups) differ in sunscreen use and sun burning pre-and post-intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • greater than 18 years of age
  • interested in enrolling in the sun protection study
  • owning a cell-phone that accepts text messages
  • willing to share their phone number with the study team

Treatment and study plan

Sunscreen

Other

Text-Message Reminders

Behavioral

Sunscreen and Text Message Reminders

Other

Education

Behavioral

Primary outcomes

  1. Sunscreen use

    Time frame: Baseline

    Subjects will complete a baseline survey during safety training sessions in Winter when they get the educational intervention. In the past summer, on the days when you were outside in the sunlight, how often did you use sun block (never, some of the time, about half the time, most of the time, always)?

  2. Sun Burning

    Time frame: Baseline

    Subjects will complete a baseline survey during safety training sessions in Winter when they get the educational intervention. On average, how many times did you get a sunburn this past summer (0, 1, 2, 3, 4 or more times)?

  3. Sunscreen use

    Time frame: Post-intervention

    Subjects will be texted or phoned this question monthly during the intervention period and will again receive this question on the longer follow up survey up to 5 months after the interventions end. In the past summer, on the days when you were outside in the sunlight, how often did you use sun block (never, some of the time, about half the time, most of the time, always)?

  4. Sun Burning

    Time frame: Post-intervention

    Subjects will be texted or phoned this question monthly during the intervention period and will again receive this question on the longer follow up survey up to 5 months after the interventions end. On average, how many times did you get a sunburn this past summer(0, 1, 2, 3, 4 or more times)?

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Blue Cross Blue Shield of Michigan Foundation

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2013
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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