Engaging Moms on Teen Indoor Tanning Through Social Media

October 18, 2022 updated by: Klein Buendel, Inc.

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A sample of mothers in Tennessee are recruited to a group-randomized pretest-posttest controlled trial evaluating the effect of a social media campaign to decrease mothers' permissiveness for daughters to indoor tan. The primary outcomes is mothers' permissiveness for indoor tanning by daughters. Secondary outcomes are mother's indoor tanning prevalence and their support for stricter bans on indoor tanning by minors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Indoor tanning (IT) elevates the risk for melanoma, which is now the most common cancer in women aged 25-29. To reduce melanoma morbidity and mortality, some states have issued complete bans on IT by minors, while others require parental permission for minors to indoor tan. Unfortunately, parental consent policies have suffered from low compliance due to industry non-compliance,likely due to insufficient policy enforcement, and parents' lack of awareness of the dangers of IT. Little attention has been paid to creating health communication that maximizes the effectiveness of IT policy, including both parental consent and bans. Mothers are an important target, because their permissiveness and IT behavior are strong predictors of daughters' IT. Teen girls often initiate IT with their mothers. and further, girls who first experience IT with their mothers begin at an earlier age, become more habitual tanners, and are more resistant to change.Thus, mothers of teen girls are a significant target for interventions to reduce IT and an effective campaign for mothers has the potential to reduce the prevalence of IT in adolescent girls and the incidence of melanoma in young women. Recent research indicates that well-crafted communication can reduce maternal permissiveness but such communication has not been tested as a strategy specifically for maximizing IT policies. A campaign that aims to a) inform mothers of IT risks b) highlight how their IT permissiveness will influence their child's current and future risks,and c) provide them with effective messages to convince daughters not to indoor tan will be developed and delivered via Facebook to maximize the effectiveness of parental-permission laws, the most prevalent IT policy in the United States. The campaign will be evaluated in a group-randomized pretest-posttest controlled trial that enrolls mothers and adolescent teen daughters aged 14 to 17 years old. Participants will be randomized to receive entry into one of two private Facebook groups that will deliver health campaigns lasting one year. In the intervention group, participants will receive a health-focused feed in which 25% of posts are focused on IT. In the control condition, participants will receive the same health-focused feed but instead of 25% of posts focused on IT, 25% of posts will focus on prescription drug abuse and misuse. Randomization will occur at the level of the Facebook private groups; 30-50 mothers from the same community will participate in each Facebook private group for a total of 50 Facebook groups recruited over the trial period. Assessment points will occur at baseline and again at 6-months and 1-year post-intervention. The primary outcome will be reduction in mothers' permissiveness regarding their teen daughter's use of indoor tanning and secondary outcomes will be increase in teen daughters' perception of their mother's permissiveness,and reduction in IT by both mothers and daughters.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1607

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523-0000
        • Colorado State University
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc.
    • Connecticut
      • Storrs, Connecticut, United States, 06269-1133
        • University of Connecticut
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria (Mothers):

  • Live in Tennessee
  • Have a daughter aged 14 to 17
  • Register for the social media campaign
  • Consent to participate
  • Read English
  • Complete the online baseline survey
  • Daughter provides assent to participate
  • Have a Facebook account or be willing to create one

Exclusion Criteria (Mothers):

  • Not reading English
  • Living outside Tennessee
  • Daughter not assenting to participate

Inclusion Criteria (Daughters)

  • Age 14-17
  • Provide assent for mother to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health Chat including Indoor Tanning
Facebook group, Health Chat, which provides information via posts within the private group about a wide variety of health topics (e.g. tobacco use, body image) with 25% of all of the content being about indoor tanning. Indoor tanning-related content was developed by the investigators and a social media marketing expert using information from published literature on IT risk factors, evidence-based intervention content from published trials targeting IT reduction, public health campaigns from major non-profit organizations (e.g., CDC, Skin Cancer Foundation, etc.), and investigator-developed video-recorded interviews of local mothers and professionals about the risks of indoor tanning, experiences with skin cancer, and mother-daughter communication role modeling.
Behavioral: Health Chat including Indoor Tanning
Participants in the intervention join a private Facebook group to participate in the Health Chat program. The group is not viewable to the public, including other Facebook users. The content of Health Chat is designed primarily for mothers, the participants in the group. Posts will occur twice daily for 12 months for a total of 720 posts. Each group will be hosted by a moderator who is responsible for managing the intervention goals and mothers' engagement. Mothers likely will not continuously engage with a social media campaign that is limited only to indoor tanning. To engage mothers in the Health Chat program, content addressing several major health and wellness topics relevant to adolescent girls and their mothers will be posted.
Active Comparator: Health Chat excluding Indoor Tanning
Facebook group, Health Chat, which provides information via posts within the private group about a wide variety of health topics (e.g. tobacco use, body image), but does not include any content about indoor tanning. The designated number of posts (25%) assigned to the indoor tanning content in the intervention group will be assigned to prescription drug use in the control arm. In order to keep number and frequency of posts standardized between the two groups, prescription drug use was selected to replace the indoor tanning content for the control arm.
Behavioral: Health Chat excluding Indoor Tanning
In the comparison condition, 25% of the posts will be about prescription drug abuse and misuse. Prescription drug abuse was selected as control content because it is a) completely unrelated to tanning, and b) an emerging issue of great interest and relevance to young adults in east Tennessee. This 25% segment of posts is the only difference between the intervention and comparison conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Mothers' Permissiveness for Daughters to Indoor Tan
Time Frame: Baseline, 6-month, and 1 year follow-up
Mothers' permissiveness for daughters to indoor tan will be assessed using 6 Likert-type items (1=strongly disagree, 5=strongly agree) assessing permissiveness toward their teenage daughter's indoor tanning. Example items include, "I would allow my daughter to indoor tan," and "I think it's OK for my daughter to indoor tan." Daughters will be asked the same 6 items to assess their perceptions of mothers' permissiveness. This measure has been used with a national teen sample. Maternal permissiveness will be assessed at baseline and both follow-ups by the combined average ratings across the six items.
Baseline, 6-month, and 1 year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Mothers' Indoor Tanning Prevalence
Time Frame: Baseline, 6-month, and 1 year follow-up
Prevalence of indoor tanning will be assessed by asking mothers to report on their indoor tanning behavior using a single open-ended item, i.e., "How many times between December 1, 2015 and March 31, 2016 have you used a tanning bed or booth?" The December to March period was selected to control for seasonality; indoor tanning is most frequent during winter and early spring. In addition, intention to indoor tan will be assessed, i.e., How likely is it that you will indoor tan in the next 3 months/6 months/12 months (7-point Likert response scale), along with intention to get a sunless tanning treatment in the next 12 months. Indoor tanning prevalence and intentions will be assessed at baseline and both follow-ups.
Baseline, 6-month, and 1 year follow-up
Change in Daughters' Indoor Tanning Prevalence
Time Frame: Baseline, 6-month, and 1 year follow-up
Prevalence of indoor tanning will be assessed by asking daughters to report on their indoor tanning behavior using a single open-ended item, i.e., "How many times between December 1, 2015 and March 31, 2016 have you used a tanning bed or booth?" The December to March period was selected to control for seasonality; indoor tanning is most frequent during winter and early spring. In addition, intention to indoor tan will be assessed, i.e., How likely is it that you will indoor tan in the next 3 months/6 months/12 months (7-point Likert response scale), along with intention to get a sunless tanning treatment in the next 12 months. Indoor tanning prevalence and intentions will be assessed at baseline and both follow-ups.
Baseline, 6-month, and 1 year follow-up
Mothers' Support for Stricter Bans on Indoor Tanning by Minors
Time Frame: 13-months after randomization
Support for strengthening bans on indoor tanning (IT) by minors will be measured via the web server which will record whether mothers click on the link to "sign" the petition to strengthen the ban on indoor tanning and forward it to their legislator.
13-months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
University of Connecticut
Colorado State University
East Tennessee State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Buller, PhD, Klein Buendel, Inc.
  • Principal Investigator: Sherry Pagoto, PhD, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0301
  • 5R01CA192652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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