NCT03448224

Brief 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. Behavioral interventions use techniques to help participants change the way they react to environmental triggers that may cause a negative reaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

February 2, 2018

Results QC Date

August 21, 2020

Last Update Submit

September 28, 2020

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 3 months

Secondary Outcomes (4)

  • Perceived Difficulty (Self-efficacy) in Quitting Tanning

    At 3 months post-intervention

  • Sunburns

    Up to 3 months

  • Intentions to Use Indoor Tanning

    Up to 3 months

  • Number of Participants Expressing Positive Interest in Changing Tanning

    3 months

Study Arms (2)

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.

Other: Questionnaire AdministrationOther: Internet-Based Intervention

Group II (wait-list)

ACTIVE COMPARATOR

Participants are placed on wait-list and may receive full intervention after follow-up.

Other: Questionnaire Administration

Interventions

Questionnaire AdministrationOTHER

Questionnaire

Group I (web-based Indoor Tanning intervention)Group II (wait-list)
Internet-Based InterventionOTHER

Intervention

Group I (web-based Indoor Tanning intervention)

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Use of IT at least 25 times in the past year
  • Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • 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.

    PMID: 33353412DERIVED

Results Point of Contact

Title
Dr. Jerod Stapleton
Organization
University of Kentucky
jerod.stapleton@uky.edu
859.562.2802

Study Officials

  • Jerod Stapleton, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 28, 2018

Study Start

April 11, 2018

Primary Completion

February 6, 2019

Study Completion

August 31, 2019

Last Updated

October 22, 2020

Results First Posted

October 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)