Trial Outcomes & Findings for An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk (NCT NCT01508013)
NCT ID: NCT01508013
Last Updated: 2016-06-02
Results Overview
Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
443 participants
Primary outcome timeframe
12 months
Results posted on
2016-06-02
Participant Flow
Participant milestones
| Measure |
Appearance-Focused Website Intervention
This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
|
Control Website
Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
229
|
|
Overall Study
COMPLETED
|
182
|
206
|
|
Overall Study
NOT COMPLETED
|
32
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
Baseline characteristics by cohort
| Measure |
Appearance-Focused Website Intervention
n=214 Participants
This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
|
Control Website
n=229 Participants
Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
|
Total
n=443 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.19 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
15.24 years
STANDARD_DEVIATION 1.91 • n=7 Participants
|
15.21 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
188 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
389 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
214 participants
n=5 Participants
|
229 participants
n=7 Participants
|
443 participants
n=5 Participants
|
|
Indoor Tanning Frequency
|
6.36 Indoor tanning sessions
STANDARD_DEVIATION 25.29 • n=5 Participants
|
5.94 Indoor tanning sessions
STANDARD_DEVIATION 23.01 • n=7 Participants
|
6.14 Indoor tanning sessions
STANDARD_DEVIATION 24.11 • n=5 Participants
|
|
Indoor Tanning Intentions Scale
|
4.14 units on a scale
STANDARD_DEVIATION 2.00 • n=5 Participants
|
3.74 units on a scale
STANDARD_DEVIATION 2.01 • n=7 Participants
|
3.93 units on a scale
STANDARD_DEVIATION 2.01 • n=5 Participants
|
|
Indoor Tanning Willingness Scale
|
4.66 units on a scale
STANDARD_DEVIATION 1.92 • n=5 Participants
|
4.55 units on a scale
STANDARD_DEVIATION 1.85 • n=7 Participants
|
4.60 units on a scale
STANDARD_DEVIATION 1.88 • n=5 Participants
|
|
Indoor Tanning Attitudes Scale
|
9.67 units on a scale
STANDARD_DEVIATION 3.35 • n=5 Participants
|
9.34 units on a scale
STANDARD_DEVIATION 3.35 • n=7 Participants
|
9.50 units on a scale
STANDARD_DEVIATION 3.35 • n=5 Participants
|
|
Indoor Tanning Social Approval Scale
|
11.99 units on a scale
STANDARD_DEVIATION 2.54 • n=5 Participants
|
11.23 units on a scale
STANDARD_DEVIATION 2.87 • n=7 Participants
|
11.59 units on a scale
STANDARD_DEVIATION 2.74 • n=5 Participants
|
|
Indoor Tanning Skin Damage Susceptibility Scale
|
18.79 units on a scale
STANDARD_DEVIATION 4.81 • n=5 Participants
|
19.20 units on a scale
STANDARD_DEVIATION 4.61 • n=7 Participants
|
19.00 units on a scale
STANDARD_DEVIATION 4.71 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the future.
Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.
Outcome measures
| Measure |
Appearance-Focused Website Intervention
n=182 Participants
This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
|
Control Website
n=206 Participants
Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
|
|---|---|---|
|
Indoor Tanning Behavior
|
5.29 Indoor tanning sessions over past year
Standard Deviation 14.89
|
6.30 Indoor tanning sessions over past year
Standard Deviation 16.08
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the next year.
A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).
Outcome measures
| Measure |
Appearance-Focused Website Intervention
n=182 Participants
This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
|
Control Website
n=206 Participants
Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
|
|---|---|---|
|
Indoor Tanning Intentions
|
2.91 units on a scale
Standard Deviation 1.96
|
3.28 units on a scale
Standard Deviation 2.10
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Adolescent females aged 12-18 years old that expressed interest in indoor tanning in the future.
Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).
Outcome measures
| Measure |
Appearance-Focused Website Intervention
n=182 Participants
This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
|
Control Website
n=206 Participants
Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
|
|---|---|---|
|
Indoor Tanning Willingness
|
3.34 units on a scale
Standard Deviation 2.16
|
3.73 units on a scale
Standard Deviation 62.22
|
Adverse Events
Appearance-Focused Website Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Website
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place