- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03441321
Social-Media Intervention in Reducing Tanning in High-Risk Tanners
Randomized Trial of a Social Media-Delivered Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To conduct a randomized control trial to examine the efficacy of the intervention versus (vs.) a Facebook-delivered control group on reducing tanning behavior among high-risk indoor and outdoor tanners.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants periodically read the content on the study-specific secret Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks.
GROUP II: Participants participate in secret Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks.
After completion of study, patients are followed up at 3, 8, and 18 months post baseline assessment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University Of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- High-risk indoor or outdoor tanner (defined as using an indoor tanning bed or intentionally tanning outdoors at least 10 times in the previous 12 months)
- Use of Facebook at least 4 times per week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (focusing on tanning and healthy body image)
Participants periodically read the content on the study-specific private and hidden Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks.
|
Ancillary studies
Participate in Facebook group focusing on avoiding tanning and promoting healthy body image
|
|
Active Comparator: Group II (focusing on other health topics)
Participants participate in private and hidden Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks.
|
Ancillary studies
Participate in Facebook group focusing on other health topics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Tanning Sessions
Time Frame: At 8 months
|
Multilevel models (e.g., random coefficient) will be used to test the primary study hypothesis that participants who received the intervention will report less combined indoor and outdoor tanning behavior at a 8-month follow-up compared to those who received the control.
If necessary, sensitivity analyses may control for individual-level covariates.
For reporting purposes, total number of tanning session were summed.
Items are measured on open-ended scales with minimum value of 0. Higher numbers report higher rates of tanning, a worse outcome considering it is a risk factor for skin cancer development.
|
At 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Indoor and Outdoor Tanning Behavior Assessed Using Surveys
Time Frame: At 18 months
|
Multilevel models (e.g., random coefficient) will be used.
If necessary, sensitivity analyses may control for individual-level covariates.
For reporting purposes, total number of tanning session were summed.
Items are measured on open-ended scales with minimum value of 0. Higher numbers report higher rates of tanning, a worse outcome considering it is a risk factor for skin cancer development.
|
At 18 months
|
|
Skin Burns From Indoor and Outdoor Tanning Assessed Using Surveys
Time Frame: At 18 months
|
Multilevel models (e.g., random coefficient) will be used.
If necessary, sensitivity analyses may control for individual-level covariates.
Due to programming error in the study surveys, sunburn was not collected at 8 months as intended.
Instead, data presented are from the 18-month, long-term follow-up.
|
At 18 months
|
|
Tanning Intentions Assessed Using Surveys
Time Frame: At 8 months
|
Multilevel models (e.g., random coefficient) will be used.
If necessary, sensitivity analyses may control for individual-level covariates.
Intentions for both indoor and outdoor tanning were summed to create a single intentions scale.
Indoor tanning intentions were assessed with the question "How likely are you to indoor tan (e.g., used a tanning bed, sun lamp, or tanning booth) in the next 12 months?"
and outdoor intentions with the question "How likely are you to sunbathe or spend time lying in the sun in the next 12 months?"
Both questions included response options on a 6-point scale ranging from extremely unlikely (coded as "1") to extremely likely (coded as "6").
The range of possible responses was 2 to 12 with higher scores indicating higher intentions (a worse outcome).
|
At 8 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jerod Stapleton, PhD, University Of Kentucky
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 56153
- P30CA072720 (U.S. NIH Grant/Contract)
- NCI-2018-00168 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- Pro20170000184
- 131704 (Other Identifier: Rutgers Cancer Institute of New Jersey)
- R01CA218068 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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