Social-Media Intervention in Reducing Tanning in High-Risk Tanners

Sponsor
Jerod L Stapleton, PhD (Other)
Overall Status
Recruiting
CT.gov ID
NCT03441321
Collaborator
National Cancer Institute (NCI) (NIH)
400
1
2
61
6.6

Study Details

Study Description

Brief Summary

This randomized clinical trial studies how well social-media intervention works in reducing tanning in high-risk indoor and outdoor tanners. Social-media intervention delivered via Facebook may help to promote healthy behaviors, positive body image, and to understand young women's perception of a social media campaign.

Condition or Disease Intervention/Treatment Phase
  • Other: Lifestyle and Values Intervention
  • Other: Lifestyle Intervention
  • Other: Survey Administration
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Randomized Trial of a Social Media-Delivered Intervention
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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.

Other: Lifestyle and Values Intervention
Participate in Facebook group focusing on avoiding tanning and promoting healthy body image

Other: Survey Administration
Ancillary studies

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.

Other: Lifestyle Intervention
Participate in Facebook group focusing on other health topics

Other: Survey Administration
Ancillary studies

Outcome Measures

Primary Outcome Measures

  1. Number of indoor or outdoor tanning sessions assessed using surveys [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.

Secondary Outcome Measures

  1. Indoor and outdoor tanning behavior assessed using surveys [At 18 months]

    Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates.

  2. Skin burns from indoor and outdoor tanning assessed using surveys [At 8 months]

    Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates.

  3. Tanning intentions assessed using surveys [At 8 months]

    Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kentucky Lexington Kentucky United States 40536

Sponsors and Collaborators

  • Jerod L Stapleton, PhD
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jerod Stapleton, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jerod L Stapleton, PhD, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT03441321
Other Study ID Numbers:
  • 56153
  • NCI-2018-00168
  • Pro20170000184
  • 131704
  • P30CA072720
First Posted:
Feb 22, 2018
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Nov 17, 2021