NCT03201120

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,595

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

June 21, 2017

Last Update Submit

November 13, 2018

Conditions

Behavior, Health

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Measure of Behavioral Intent

    Baseline

Study Arms (2)

Outdoor Sun Exposure Behavior

EXPERIMENTAL

A convenience sample of white, English-speaking adults ages 18 to 49 will be recruited via online advertisements in Philadelphia and the surrounding region (within a 30 mile radius). The investigators will recruit 120 adults to test outdoor UV exposure messages. The investigators will quota sample to ensure representation across age and gender groups. The inclusion criteria are that adults must be white, must be between 18-49 years old and must speak English.

Behavioral: Outdoor Sun Behavior

Indoor Tanning Behavior

EXPERIMENTAL

A convenience sample of white, English-speaking females ages 18 to 25 will be recruited via online advertisements and flyers in Philadelphia and the surrounding region (within a 30 mile radius). The investigators will recruit 60 adults to test indoor tanning messages. The inclusion criteria are that adults must be white, female, must be between 18-25 years old, must have used an indoor tanning bed at least once in the past 12 months, and must speak English.

Behavioral: Indoor Tanning Behavior

Interventions

Outdoor Sun BehaviorBEHAVIORAL

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.

Outdoor Sun Exposure Behavior
Indoor Tanning BehaviorBEHAVIORAL

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.

Indoor Tanning Behavior

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • year old non-Hispanic white (NHW) adults
  • OR 18-25 year old NHW females who have tanned indoors in the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIRNA Lab

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Karen Glanz, PhD, MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology and Nursing

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 28, 2017

Study Start

March 29, 2017

Primary Completion

September 28, 2017

Study Completion

September 28, 2017

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)