Behavior, HealthNCT03201120
Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing
A study testing Outdoor Sun Behavior and Indoor Tanning Behavior in people with Behavior, Health, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Behavior, Health
- What is being tested?
- Outdoor Sun Behavior and Indoor Tanning Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,595 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Behavior, Health
- Being tested
- Outdoor Sun Behavior, Indoor Tanning Behavior
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor Sun BehaviorBehavioural
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 BehaviorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Indoor Tanning Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Two weeks post baseline Laboratory Survey
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start29 Mar 2017
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,595 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Karen Glanz, University of Pennsylvania
- Investigators
- Karen Glanz, PhD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201120
- Sponsor's protocol ID
- 821348
- Status last verified
- Nov 2018
- First submitted
- 21 Jun 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing
- ClinicalTrials.gov ID
- NCT03201120
- Acronym / sponsor ID
- 821348
- Conditions
- Behavior, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,595 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor Sun Exposure Behavior | Experimental | Behavioral: Outdoor Sun BehaviorA 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. |
| Indoor Tanning Behavior | Experimental | Behavioral: Indoor Tanning BehaviorA 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outdoor Sun BehaviorParticipants 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. | Behavioural | Outdoor Sun Exposure Behavior |
| Indoor Tanning BehaviorUpon 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. | Behavioural | Indoor Tanning Behavior |
Primary outcome
Laboratory Survey
Time frame: Baseline
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.
Follow-up Survey
Time frame: Two weeks post baseline Laboratory 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.
1 secondary outcome
Measure of Behavioral Intent
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Glanz, PhD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor Sun Behavior and Indoor Tanning Behavior in people with Behavior, Health, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory Survey (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.