Skin CancerNCT02835807
Engaging Moms on Teen Indoor Tanning Through Social Media
A study testing Health Chat including Indoor Tanning and Health Chat excluding Indoor Tanning in people with Skin Cancer, run by Klein Buendel, Inc. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Health Chat including Indoor Tanning and Health Chat excluding Indoor Tanning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,607 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2015to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Daughter provides assent to participate
- Have a Facebook account or be willing to create one
- Age 14-17
- Provide assent for mother to participate
Who cannot join
- Not reading English
- Living outside Tennessee
- Daughter not assenting to participate
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Colorado State University
Fort Collins, Colorado, 80523-0000
Klein Buendel, Inc.
Golden, Colorado, 80401
East Tennessee State University
Johnson City, Tennessee, 37604
University of Connecticut
Storrs, Connecticut, 06269-1133
About this study
Official title: Likes Pins and Views: Engaging Moms on Teen Indoor Tanning Thru Social Media
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.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- Health Chat including Indoor Tanning, Health Chat excluding Indoor Tanning
- Keywords
- skin cancer
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Chat including Indoor TanningBehavioural
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.
Health Chat excluding Indoor TanningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Chat including Indoor Tanning | Experimental | 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. Receives: Behavioral: Health Chat including Indoor Tanning |
| Health Chat excluding Indoor Tanning | Active comparator | 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. Receives: Behavioral: Health Chat excluding Indoor Tanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mothers' Permissiveness for Daughters to Indoor Tan
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.
Measured: Baseline, 6-month, and 1 year follow-up
Secondary outcomes (3)
Change in Mothers' Indoor Tanning Prevalence
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.
Measured: Baseline, 6-month, and 1 year follow-up
Change in Daughters' Indoor Tanning Prevalence
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.
Measured: Baseline, 6-month, and 1 year follow-up
Mothers' Support for Stricter Bans on Indoor Tanning by Minors
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.
Measured: 13-months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJun 2015
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- East Tennessee State University, Colorado State University, University of Connecticut, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Buller, PhD, Principal investigator, Klein Buendel, Inc.Sherry Pagoto, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835807
- Sponsor's protocol ID
- 0301
- Other IDs
- 5R01CA192652
- Status last verified
- Oct 2022
- First submitted
- 14 Jul 2016
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buller D, Walkosz B, Henry K, Woodall WG, Pagoto S, Berteletti J, Kinsey A, Divito J, Baker K, Hillhouse J. Promoting Social Distancing and COVID-19 Vaccine Intentions to Mothers: Randomized Comparison of Information Sources in Social Media Messages. JMIR Infodemiology. 2022 Aug 23;2(2):e36210. doi: 10.2196/36210. eCollection 2022 Jul-Dec.
PubMed 36039372Buller DB, Pagoto S, Henry K, Berteletti J, Walkosz BJ, Bibeau J, Baker K, Hillhouse J, Arroyo KM. Human Papillomavirus Vaccination and Social Media: Results in a Trial With Mothers of Daughters Aged 14-17. Front Digit Health. 2021 Sep 3;3:683034. doi: 10.3389/fdgth.2021.683034. eCollection 2021.
PubMed 34713152Pagoto SL, Baker K, Griffith J, Oleski JL, Palumbo A, Walkosz BJ, Hillhouse J, Henry KL, Buller DB. Engaging Moms on Teen Indoor Tanning Through Social Media: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2016 Nov 29;5(4):e228. doi: 10.2196/resprot.6624.
PubMed 27899339
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Likes Pins and Views: Engaging Moms on Teen Indoor Tanning Thru Social Media
- ClinicalTrials.gov ID
- NCT02835807
- Acronym / sponsor ID
- 0301
- Conditions
- Skin Cancer
- Keywords
- skin cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,607 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- East Tennessee State University, Colorado State University, University of Connecticut, National Cancer Institute (NCI)
- Study start
- Jun 2015 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Chat including Indoor Tanning | Experimental | Behavioral: Health Chat including Indoor TanningFacebook 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. |
| Health Chat excluding Indoor Tanning | Active comparator | Behavioral: Health Chat excluding Indoor TanningFacebook 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Live in Tennessee
- Have a daughter aged 14 to 17
- Register for the social media campaign
- Consent to participate
- Read English
Key exclusion criteria (3 listed)
- Not reading English
- Living outside Tennessee
- Daughter not assenting to participate
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 |
|---|---|---|
| Health Chat including Indoor TanningParticipants 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. | Behavioural | Health Chat including Indoor Tanning |
| Health Chat excluding Indoor TanningIn 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. | Behavioural | Health Chat excluding Indoor Tanning |
Primary outcome
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.
3 secondary outcomes
Change in Mothers' Indoor Tanning Prevalence
Time frame: Baseline, 6-month, and 1 year follow-up
Change in Daughters' Indoor Tanning Prevalence
Time frame: Baseline, 6-month, and 1 year follow-up
Mothers' Support for Stricter Bans on Indoor Tanning by Minors
Time frame: 13-months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 36039372Buller D, Walkosz B, Henry K, Woodall WG, Pagoto S, Berteletti J, Kinsey A, Divito J, Baker K, Hillhouse J. Promoting Social Distancing and COVID-19 Vaccine Intentions to Mothers: Randomized Comparison of Information Sources in Social Media Messages. JMIR Infodemiology. 2022 Aug 23;2(2):e36210. doi: 10.2196/36210. eCollection 2022 Jul-Dec.
- Derived from this study: PubMed 34713152Buller DB, Pagoto S, Henry K, Berteletti J, Walkosz BJ, Bibeau J, Baker K, Hillhouse J, Arroyo KM. Human Papillomavirus Vaccination and Social Media: Results in a Trial With Mothers of Daughters Aged 14-17. Front Digit Health. 2021 Sep 3;3:683034. doi: 10.3389/fdgth.2021.683034. eCollection 2021.
- Derived from this study: PubMed 27899339Pagoto SL, Baker K, Griffith J, Oleski JL, Palumbo A, Walkosz BJ, Hillhouse J, Henry KL, Buller DB. Engaging Moms on Teen Indoor Tanning Through Social Media: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2016 Nov 29;5(4):e228. doi: 10.2196/resprot.6624.
- 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.
David Buller, PhD principal investigator
Klein Buendel, Inc.
Sherry Pagoto, PhD principal investigator
University of Connecticut
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Chat including Indoor Tanning and Health Chat excluding Indoor Tanning in people with Skin Cancer, run by Klein Buendel, Inc. at 4 sites 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 10 inclusion and 3 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 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Mothers' Permissiveness for Daughters to Indoor Tan (time frame: Baseline, 6-month, and 1 year follow-up). 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 NCT02835807, which also lists 3 linked publications.
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 20 Oct 2022.