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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03201120
Other study ID # 821348
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2017
Est. completion date September 28, 2017

Study information

Verified date November 2018
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 3b of the research will be a laboratory experiment that uses an experimental and analytic design that is parallel to that used in Phase 3a, the online experiment. The primary objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral intentions and UV-related behavioral choices post-exposure. Including time for preparation, viewing, and removal of the monitoring equipment, the message viewing session will take about 45 minutes per session.


Recruitment information / eligibility

Status Completed
Enrollment 3595
Est. completion date September 28, 2017
Est. primary completion date September 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- 18-49 year old non-Hispanic white (NHW) adults

- OR 18-25 year old NHW females who have tanned indoors in the past 12 months

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Outdoor Sun Behavior
Participants will provide informed consent and complete a short background questionnaire about usual sun exposure and protection behaviors and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a computer monitor, keyboard and mouse setup. Each participant will view messages with different emotional appeals related to outdoor sun exposure (seeking shade, covering up, using sunscreen, and multiple behaviors). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.
Indoor Tanning Behavior
Upon arrival, participants will provide informed consent and complete a short background questionnaire about usual indoor tanning, sun exposure and protection behaviors, and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a typical computer monitor, keyboard and mouse setup. Each participant will view messages with each type of target behavior (freedom, health risk, appearance)). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.

Locations

Country Name City State
United States CIRNA Lab Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Laboratory Survey Questionnaire measures will be completed using an iPad with Qualtrics software. Participants will be asked to evaluate each message for its argument strength, emotional appeal, and themes; participants will also be asked about their intentions and beliefs related to each behavior. The research technician will not initiate a conversation with the participant during the experimental session except to give instructions. Baseline
Primary Follow-up Survey Two weeks after the completed laboratory session, participants will be emailed a link to complete a follow-up survey. The survey will ask about participants' ability to recall the messages, attitudes regarding outdoor sun protection behaviors, actual behaviors in the past two weeks, whether the participants have used or will use the product they selected, and whether the participants have discussed the messages with anyone else. Two weeks post baseline Laboratory Survey
Secondary Measure of Behavioral Intent Upon finishing the experiment, respondents will be offered a choice of one of four "thank you" gifts of comparable value: sunscreen, hand sanitizer, and moisturizer with or without SPF protection. The experimenter will unobtrusively record the subjects' selections. Baseline
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