Health Status Unknown
Conditions
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.
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.
Interventions
OTHERLifestyle and Values Intervention
Participate in Facebook group focusing on avoiding tanning and promoting healthy body image
OTHERLifestyle Intervention
Participate in Facebook group focusing on other health topics
OTHERSurvey Administration
Ancillary studies
Sponsors
Jerod L Stapleton, PhD
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Tanning Sessions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. |
| Skin Burns From Indoor and Outdoor Tanning 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. 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. |
| 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. 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJerod Stapleton, PhD
University of Kentucky
Participant flow
Recruitment details
Participants were primarily recruited by the internet research recruitment company Qualtrics Sample Providers. Qualtrics emailed a randomly selected sample frame of panel participants with a study invitation, which contained a brief description of the study procedures and a brief screening eligibility assessment. Qualtrics also supplemented recruitment with web advertisements posted on various websites and platforms of their partner organizations.
Pre-assignment details
Following screening, eligible participants who indicated their interest were emailed by study staff a link to a web-based baseline survey that also included the implied consent form. After completing the baseline survey, participants were randomized to condition.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 407 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Indoor tanning sessions | 4.44 tanning sessions STANDARD_DEVIATION 15.81 |
| Outdoor tanning sessions | 22.73 tanning sessions STANDARD_DEVIATION 21.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 152 Participants |
| Sex: Female, Male Female | 203 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 203 |
| other Total, other adverse events | 0 / 204 | 0 / 203 |
| serious Total, serious adverse events | 0 / 204 | 0 / 203 |
Outcome results
None listed