Mobile Phone Text Messaging for Tobacco Risk Communication Among Young Adult Community College Students: Protocol and Baseline Overview for a Randomized Controlled Trial

Background Community-college students are at high risk for tobacco use. Because the use of mobile phone text messaging is nearly ubiquitous today, short message service (SMS) may be an effective strategy for tobacco risk communication in this population. Little is known, however, concerning the message structure significantly influencing perceived tobacco risk. Objective We aim to outline the rationale and design of Project Debunk, a randomized trial comparing the effects of different SMS text message structures. Methods We conducted a 6-month randomized trial comparing 8 arms, based on the combination of the 3 message structures delivered to young adults in a 2×2×2 study design: framing (gain-framed or loss-framed), depth (simple or complex), and appeal (emotional or rational). Participants were invited to participate from 3 community colleges in Houston from September 2016 to July 2017. Participants were randomized to 1 arm and received text messages in 2 separate campaigns. Each campaign consisted of 2 text messages per day for 30 days. Perceived tobacco risk was assessed at baseline, 2 months after the first campaign, and 2 months after the second campaign. We assessed the perceived risk of using conventional products (eg, combustible cigarettes) and new and emerging products (eg, electronic cigarettes). The validity of message structures was assessed weekly for each campaign. A 1-week follow-up assessment was also conducted to understand immediate reactions from participants. Results We completed data collection for the baseline survey on a rolling basis during this time and assessed the validity of the message structure after 1 week of SMS text messages. For the entire sample (N=636), the average age was 20.92 years (SD 2.52), about two-thirds were male (430/636, 67.6%), and most were black or African American (259/636, 40.7%) or white (236/636, 37.1%). After 1 week of receiving text messages, the following was noted: (a) loss-framed messages were more likely to be perceived as presenting a loss than gain-framed messages (F7,522=13.13, P<.001), (b) complex messages were perceived to be more complex than simple messages (F7,520=2.04, P=.05), and (c) emotional messages were perceived to be more emotionally involving than rational messages (F7,520=6.46, P<.001). Conclusions This study confirms that the recruitment, randomization, and message composition have been successfully implemented. Further analyses will identify specific types of messages that are more effective than others in increasing the perceived risk of tobacco use. If our results suggest that any of the 8 specific message structures are more effective for helping young adults understand tobacco risk, this would provide evidence to include such messages as part of a larger technology-based campaign such as mobile phone apps, entertainment-based campaigns, and social media. Trial Registration ClinicalTrials.gov NCT03457480; https://clinicaltrials.gov/ct2/show/NCT03457480 (Archived by WebCite at http://www.webcitation.org/6ykd4IIap) Registered Report Identifier RR1-10.2196/10977

Assessing awareness of dangers and attitudes toward tobacco products, especially emerging ones, among young adults would be useful information. As would assessing moderators of these attitudes. This could enable FDA to craft messages and regulate how products are advertised. 1 P50 CA180906-01 39 ZRG1 BDCN-A (40) PERRY, C Developing effective messages than can communicate the dangers of tobacco products and alter attitudes would be a significant outcome that would inform regulatory science.

Weaknesses
While developing effective message tones, styles, and characteristics would be significant and useful information for the FDA to deliver information via various modes, and while testing messages via texts can be an effective, cheap, and quick way to do this, the application does not describe how text messages might actually be used in the real world by the FDA and it is hard to imagine how this might work. So even if text message are effective it is unclear how this could actually be implemented or would be relevant for FDA use or FDA regulation. Would the FDA be sending texts to random young adults? Even outside of the FDA, how could it be implemented --would community colleges get the cell phone numbers of all students or students who were at risk and text them? Those two options would be annoying to recipients and costly outside of this study where participants get reimbursed for cell expenses (since texts typically cost the receiver). Perhaps people could sign up to get tobacco education texts, but who would do that?

Strengths
Dr. Pokhorov has experience in tobacco interventions for young adults as well developing tailored electronic messages for health promotion.
Other members of the team have strengths in communication and electronic messaging and well as health behavior theory.

Weaknesses
In the budget, page 235, of this application Drs. Vidrine and Calabro are listed as "Co-PI," Dr. Prokhorov is listed as "PD/PI." It appears that this is an error and that Drs. Vidrine and Calabro are actually Co-Is as they are listed in the budget justification (page 238). Otherwise a multiple PI plan is missing and needed.
Investigators seem to have experience in the areas of tobacco, young adult research, communication research and electronic communication however it is a bit of a leap to assume this as their preliminary studies subsection gave very little detail or concrete examples of their previous work.

Innovation: Strengths
A better understanding of young adult perceptions of tobacco harm would aid in regulating how products are advertised.
This proposal would advance the science of what messaging content and characteristics might stick with young adults.

Weaknesses
There is an assumption that text messages would be an appropriate mode for the FDA to use in communication but there is no support for that.
There is no attempt to discover what mode of communication (text or others) might be most appropriate on both ends of the communicationboth for the FDA to use to broadcast messages and for young adults and how they might prefer receiving messages.
Survey measures well-detailed, appropriate, and concise. Conducting the survey via cell phone is a strength given that participants will be interacting with the study intervention via cell phone. This survey mode should promote a good response rate. The focus groups to develop messages is a strength. The factorial design is an efficient way to test multiple message characteristics.

Weaknesses
What if all of the students who volunteer for the study already perceive the tobacco products to be risky? How can change in perceptions be measured? As the application mentioned, over ¾ of high school seniors in Monitoring the Future perceive "great risk" in smoking a pack of cigarettes a day. There might not be room for change.
Given the recruitment plan, the sample may be very nuanced and the generalizability of Aim 1's results could be limited.
It is unclear why the hypothesis behind Aim 1 is related to comparing risk perception of emerging products to the risk perception of conventional products. That comes with the assumption that the risk perception of conventional products is adequately high. Instead it would be important to document the risk perception of various products, all of which are risky and should be perceived as such.
Concerns about adequate sample size to achieve Aim 3. The "rule of thumb" of 10:1 events to variables is not a rigorous standard and it is unclear what detectable difference it assumes.
Concerns that with the cross-over design, the three-month washout period is inadequate. It is unknown how long these messages "last." One would hope that they would last longer than three months.
Application makes several analogies to the effect the Fairness Doctrine had on perception of the dangers of smoking. Given this, would it not make more sense to use the same channel/s for message delivery that the tobacco companies are using rather than texting?

Environment: Strengths
The environment appears to be very supportive for this type of research.

Weaknesses
None noted.

CRITIQUE 2:
Overall Impact: It is highly likely that this project will exert an influence on the regulation of tobacco products and protection of public health. The project will provide a critical new understanding of conventional and new/emerging tobacco knowledge and usage among young adults. The project will achieve this by focusing on highly susceptible community college students and providing valuable insight into how to calibrate and compose highly accurate text messages to counter misleading tobacco marketing, educate young adults about tobacco use, and better convey the risks associated with new/emerging tobacco products. This project has a high impact potential given that it uses text messaging to deliver health messages to a very hard-to-reach segment of the population. It will make an impact by providing the FDA with a tested library of potentially scalable text messages that can potentially be used with other groups of young adults throughout the country. In addition, the project's statistical analysis will provide valuable new data pertaining to awareness, attitudes, perceptions, and receptivity of the harmful health ramifications of conventional and new/emerging tobacco products. Given the considerable strengths of the project, the only potential weakness concerns whether the project's five-year timeline could potentially be sped up given the urgency of the research need and the project organization's institutional capacity and proven experience.

Significance: Strengths
The project addresses a range of research priorities including better understanding the diversity of tobacco products, behaviors of individuals using new/emerging tobacco products, and a more sophisticated understanding of tobacco products public health communication.
The project addresses significant information gaps pertaining to the use of mobile phone messaging to inform young adults about the risk of conventional cigarettes and new/emerging tobacco.

Weaknesses
A portion of the project is aimed at better understanding young adult usage of new/emerging tobacco products though only a relative small portion (18%) of young adults actually report using these products.

Investigator(s): Strengths
The PI, Co-Investigators, and other researchers are all highly suited to the project. Each brings a unique background and experience that complements the aims of the project.
Investigators have extensive collective experience designing text messages and recruiting and retaining college students in a text-message-based program.
The PI has extensive experience conducting tobacco-related studies, particularly examining usage among high-school, community college, and university students.
The PI brings highly complementary experience given involvement with Project ACTION which uses cell phone-delivered text messages as part of a smoking cessation program and extensive studies of risk perceptions of new/emerging tobacco among youth.

Co-Investigators have highly complementary and integrated experience.
Weaknesses None noted.

Innovation: Strengths
The project seeks to shift current research by utilizing technology to fully examine an overlooked and highlyvulnerable segment of the population.
The project utilizes a novel, inexpensive, and highly-effective means of communication and data-gathering (text-messaging via mobile phones).
The project is scalable to other susceptible groups of young adults across the United States.

Approach: Strengths
The project's overall strategy, methodology, and analyses are very well-reasoned and highly suited to the specific aims of the project.
The project draws upon and is a logical advancement of previous and on-going work including Project ASPIRE, Project "Look At Your Health," and Project ACTION.
The project team has significant experience working with young adults, designing text messages, and completing studies using cell phones.
Excellent use of prior experience to keep surveys short, easily accessible (via cell phone), and ultimately more effective.

Weaknesses
A separate text messaging investigation noted that young adults reported "high satisfaction with five messages per day." This seems rather high in terms of the likelihood of young adults actually taking the time to read and absorb text message content. This project, however, recommends a dosage of two texts per day. This is clearly lower yet some skepticism remains that young adults will remain actively engaged with this daily blitz of information.

Strengths
The scientific environment in which the work will be done is well suited for this project and is highly likely to contribute to the project's probability of success.
The institutional support and physical resources necessary are readily available and more than adequate for this project.
It is highly likely that the project will benefit from the scientific environment, unique subject populations, and collaborative arrangements.
Weaknesses None noted.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections Excellent consideration of, and experience with, recruitment, informed consent, and protections against risk.

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): Acceptable
Data protection sufficiently reviewed on behalf of both participants and overall project management.

Inclusion of Women, Minorities and Children:
G1A -Both Genders, Acceptable M1A -Minority and Non-minority, Acceptable C1A -Children and Adults, Acceptable Vertebrate Animals: Not Applicable (No Vertebrate Animals) Biohazards: Not Applicable (No Biohazards) Applications from Foreign Organizations: Not Applicable (No Foreign Organizations) Select Agents: Not Applicable (No Select Agents) Resource Sharing Plans: Acceptable Data Sharing Plan fulfills the aims of the project and will likely benefit the overall research community. Budget and Period of Support: Recommend as Requested