Healthy SubjectNCT03448224
Behavioral Intervention in Reducing Indoor Tanning
A study testing Questionnaire Administration and Internet-Based Intervention in people with Healthy Subject, run by Jerod L Stapleton, PhD at 1 site in United States.
Trial summary
This randomized clinical trial tests the efficacy of a behavioral intervention works in reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of developing skin cancers. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Questionnaire Administration and Internet-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Use of IT at least 25 times in the past year
- Women
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development and Evaluation of a Behavioral Intervention to Reduce Indoor Tanning
This randomized clinical trial tests the efficacy of a behavioral intervention works in reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of developing skin cancers. Behavioral interventions use techniques to help participants change the way they react to environmental triggers that may cause a negative reaction.
Read the detailed description
PRIMARY OBJECTIVE:
To develop and evaluate an online tailored indoor tanning (IT) intervention based on findings from phase 1.
OUTLINE:
INTERVENTION: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.
GROUP II: Participants are placed on wait-list and may receive full intervention after follow-up.
After completion of study, patients are followed up at 3 months.
- Conditions
- Healthy Subject
- Being tested
- Questionnaire Administration, Internet-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Questionnaire
Internet-Based InterventionOther
Intervention
| Study group | Role | What they receive |
|---|---|---|
| Group I (web-based Indoor Tanning intervention) | Experimental | Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks. Receives: Other: Questionnaire Administration; Other: Internet-Based Intervention |
| Group II (wait-list) | Active comparator | Participants are placed on wait-list and may receive full intervention after follow-up. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey
On the follow-up assessment administered 3 months after the baseline assessment, participants will estimate the number of times they used a tanning bed or booth with tanning lamps in the past 2 months with an open-ended response.
Measured: Up to 3 months
Secondary outcomes (4)
Perceived Difficulty (Self-efficacy) in Quitting Tanning
Measured at post-intervention data collection (3 months post intervention) using single item assessment: "How hard would it be for you to stop using tanning beds/booths?" (Please answer on a scale for 0-10, where 0 is "Not at all hard", 10 is "Extremely hard").
Measured: At 3 months post-intervention
Sunburns
On the follow-up assessment administered 3 months after the baseline assessment, participants will estimate the number of times they had a sunburn in the past 2 months with an open-ended response.
Measured: Up to 3 months
Intentions to Use Indoor Tanning
For tanning intentions, participants indicated how likely they were to use an indoor tanning bed in the next year on a 6-point response scale anchored with 1 = Extremely unlikely and 6 = Extremely likely
Measured: Up to 3 months
Number of Participants Expressing Positive Interest in Changing Tanning
Interest in changing tanning was assessed using a single item: Would you like to reduce or quit indoor tanning if you could do so easily? Responses coded as 0 = no and 1 = yes
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start11 Apr 2018
- Primary completion6 Feb 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerod L Stapleton, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Jerod L Stapleton, PhD, University of Kentucky
- Investigators
- Jerod Stapleton, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448224
- Sponsor's protocol ID
- 131315
- Other IDs
- NCI-2018-00063, Pro2013003349, 131315, K07CA175115, P30CA072720
- Status last verified
- Sep 2020
- First submitted
- 2 Feb 2018
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stapleton JL, Ray AE, Glenn SD, McLouth LE, Parmar V, Manne SL. A randomized controlled trial of a web-based personalized feedback intervention targeting frequent indoor tanning bed users: Engagement, acceptability, and preliminary behavioral outcomes. J Health Psychol. 2022 Mar;27(4):923-935. doi: 10.1177/1359105320982038. Epub 2020 Dec 22.
PubMed 33353412
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of a Behavioral Intervention to Reduce Indoor Tanning
- ClinicalTrials.gov ID
- NCT03448224
- Acronym / sponsor ID
- 131315
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Jerod L Stapleton, PhDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial tests the efficacy of a behavioral intervention works in reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of developing skin cancers. Behavioral interventions use techniques to help participants change the way they react to environmental triggers that may cause a negative reaction.
Detailed description
PRIMARY OBJECTIVE:
To develop and evaluate an online tailored indoor tanning (IT) intervention based on findings from phase 1.
OUTLINE:
INTERVENTION: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.
GROUP II: Participants are placed on wait-list and may receive full intervention after follow-up.
After completion of study, patients are followed up at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (web-based Indoor Tanning intervention) | Experimental | Other: Questionnaire Administration, Other: Internet-Based InterventionParticipants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks. |
| Group II (wait-list) | Active comparator | Other: Questionnaire AdministrationParticipants are placed on wait-list and may receive full intervention after follow-up. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Use of IT at least 25 times in the past year
- Women
Key exclusion criteria (0 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 |
|---|---|---|
| Questionnaire AdministrationQuestionnaire | Other | Group I (web-based Indoor Tanning intervention), Group II (wait-list) |
| Internet-Based InterventionIntervention | Other | Group I (web-based Indoor Tanning intervention) |
Primary outcome
Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey
Time frame: Up to 3 months
On the follow-up assessment administered 3 months after the baseline assessment, participants will estimate the number of times they used a tanning bed or booth with tanning lamps in the past 2 months with an open-ended response.
4 secondary outcomes
Perceived Difficulty (Self-efficacy) in Quitting Tanning
Time frame: At 3 months post-intervention
Sunburns
Time frame: Up to 3 months
Intentions to Use Indoor Tanning
Time frame: Up to 3 months
Number of Participants Expressing Positive Interest in Changing Tanning
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33353412Stapleton JL, Ray AE, Glenn SD, McLouth LE, Parmar V, Manne SL. A randomized controlled trial of a web-based personalized feedback intervention targeting frequent indoor tanning bed users: Engagement, acceptability, and preliminary behavioral outcomes. J Health Psychol. 2022 Mar;27(4):923-935. doi: 10.1177/1359105320982038. Epub 2020 Dec 22.
- 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.
Jerod Stapleton, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Internet-Based Intervention in people with Healthy Subject, run by Jerod L Stapleton, PhD 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 0 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 22 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448224, which also lists 1 linked publication.
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 22 Oct 2020.