Health Status UnknownNCT03441321
Social-Media Intervention in Reducing Tanning in High-Risk Tanners
A study testing Lifestyle and Values Intervention, Lifestyle Intervention and Survey Administration in people with Health Status Unknown, run by Jerod L Stapleton, PhD at 1 site in United States.
Trial 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. 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
- Health Status Unknown
- What is being tested?
- Lifestyle and Values Intervention, Lifestyle Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 19 Nov 2024
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of a Social Media-Delivered Intervention
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Health Status Unknown
- Being tested
- Lifestyle and Values Intervention, Lifestyle Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle and Values InterventionOther
Participate in Facebook group focusing on avoiding tanning and promoting healthy body image
Lifestyle InterventionOther
Participate in Facebook group focusing on other health topics
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (focusing on tanning and healthy body image) | Experimental | 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. Receives: Other: Lifestyle and Values Intervention; Other: Survey Administration |
| Group II (focusing on other health topics) | Active comparator | 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. Receives: Other: Lifestyle Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Tanning Sessions
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.
Measured: At 8 months
Secondary outcomes (3)
Indoor and Outdoor Tanning Behavior Assessed Using Surveys
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.
Measured: At 18 months
Skin Burns From Indoor and Outdoor Tanning Assessed Using Surveys
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.
Measured: At 18 months
Tanning Intentions Assessed Using Surveys
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).
Measured: At 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jun 2019
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
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 Health Status UnknownStudies 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
- 407 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
- NCT03441321
- Sponsor's protocol ID
- 56153
- Other IDs
- NCI-2018-00168, Pro20170000184, 131704, P30CA072720, R01CA218068
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2018
- Last updated
- 27 Feb 2026
- 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, Manne SL, Pagoto SL, Leip A, Greene K, Hillhouse JJ, Merritt AS, Shelton BJ. A Social Media-Delivered Melanoma Prevention Program for Young Women Engaged in Frequent UV Tanning: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 19;13:e56562. doi: 10.2196/56562.
PubMed 38502173
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Social Media-Delivered Intervention
- ClinicalTrials.gov ID
- NCT03441321
- Acronym / sponsor ID
- 56153
- Conditions
- Health Status Unknown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Jerod L Stapleton, PhDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 27 Feb 2026
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 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.
Detailed description
PRIMARY OBJECTIVES:
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (focusing on tanning and healthy body image) | Experimental | Other: Lifestyle and Values Intervention, Other: Survey AdministrationParticipants 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. |
| Group II (focusing on other health topics) | Active comparator | Other: Lifestyle Intervention, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Lifestyle and Values InterventionParticipate in Facebook group focusing on avoiding tanning and promoting healthy body image | Other | Group I (focusing on tanning and healthy body image) |
| Lifestyle InterventionParticipate in Facebook group focusing on other health topics | Other | Group II (focusing on other health topics) |
| Survey AdministrationAncillary studies | Other | Group I (focusing on tanning and healthy body image), Group II (focusing on other health topics) |
Primary outcome
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.
3 secondary outcomes
Indoor and Outdoor Tanning Behavior Assessed Using Surveys
Time frame: At 18 months
Skin Burns From Indoor and Outdoor Tanning Assessed Using Surveys
Time frame: At 18 months
Tanning Intentions Assessed Using Surveys
Time frame: At 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38502173Stapleton JL, Manne SL, Pagoto SL, Leip A, Greene K, Hillhouse JJ, Merritt AS, Shelton BJ. A Social Media-Delivered Melanoma Prevention Program for Young Women Engaged in Frequent UV Tanning: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 19;13:e56562. doi: 10.2196/56562.
- 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 Lifestyle and Values Intervention, Lifestyle Intervention and Survey Administration in people with Health Status Unknown, 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 27 Feb 2026. 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 27 Feb 2026). 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?
Total Tanning Sessions (time frame: At 8 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 NCT03441321, 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 27 Feb 2026.