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Engaging Moms on Teen Indoor Tanning Through Social Media

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ClinicalTrials.gov Identifier: NCT02835807
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
East Tennessee State University
Colorado State University
University of Connecticut
Information provided by (Responsible Party):
Klein Buendel, Inc.

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 18, 2016
Last Update Posted Date March 26, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02835807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Engaging Moms on Teen Indoor Tanning Through Social Media
Official Title  ICMJE Likes Pins and Views: Engaging Moms on Teen Indoor Tanning Thru Social Media
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Skin Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Health Chat including Indoor Tanning
  • 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.
    Intervention: Behavioral: Health Chat excluding Indoor Tanning
Publications * Pagoto 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2016)
4200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jullia Berteletti 303-565-43321 jBerteletti@kleinbuendel.com
Contact: David Buller, PhD 303-565-4321 dbuller@kleinbuendel.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02835807
Other Study ID Numbers  ICMJE 5R01CA192652-02( U.S. NIH Grant/Contract )
0301 ( Other Identifier: Klein Buendel, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Klein Buendel, Inc.
Study Sponsor  ICMJE Klein Buendel, Inc.
Collaborators  ICMJE
  • East Tennessee State University
  • Colorado State University
  • University of Connecticut
Investigators  ICMJE
Principal Investigator: David Buller, PhD Klein Buendel, Inc.
Principal Investigator: Sherry Pagoto, PhD University of Connecticut
PRS Account Klein Buendel, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP