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Randomized controlled trial of MyLastDip: a Web-based smokeless tobacco cessation program for chewers ages 14-25.

ABSTRACT: INTRODUCTION:Use of smokeless tobacco (ST) is a significant public health problem for young adults, many of whom want to quit. We describe the outcome of a Randomized Controlled Trial (RCT) examining the efficacy of two web-based ST cessation interventions targeting young chewers. METHODS:One thousand seven hundred and sixteen ST users wanting to quit were recruited online to the MyLastDip program and randomly assigned to one of two fully automated web-based ST cessation interventions: (a) an Enhanced Condition (N = 857) with tailored treatment recommendations and interactive features, or (b) a Basic Condition (N = 859) that provided an online ST cessation guide in static text. RESULTS:Assessment completion rates at 3 months, 6 months, and for both 3 and 6 months were 73%, 71%, and 65%, respectively. No significant differences were found between conditions. Using complete case analysis for repeated point prevalence (3- and 6-month assessments), all tobacco abstinence was 28.9% for participants in the Enhanced Condition and 25.6% in the Basic Condition. Using intent-to-treat analysis, abstinence rates were 35.2% versus 32.3%. Similar results were obtained for ST abstinence. Participants reported being satisfied with their programs and the Enhanced Condition participants were relatively more engaged. Differences in program engagement were not related to tobacco abstinence at 6 months. CONCLUSIONS:Both web-based ST cessation programs encouraged robust levels of absolute tobacco and ST abstinence at follow-up. The absence of between-group differences was discussed in terms of composition of the control condition and implications for next steps in treatment development and testing.

SUBMITTER: Danaher BG

PROVIDER: S-EPMC3741058 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Randomized controlled trial of MyLastDip: a Web-based smokeless tobacco cessation program for chewers ages 14-25.

Danaher Brian G BG Severson Herbert H HH Andrews Judy A JA Tyler Milagra S MS Lichtenstein Edward E Woolley Timothy G TG Seeley John R JR

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20130214 9

<h4>Introduction</h4>Use of smokeless tobacco (ST) is a significant public health problem for young adults, many of whom want to quit. We describe the outcome of a Randomized Controlled Trial (RCT) examining the efficacy of two web-based ST cessation interventions targeting young chewers.<h4>Methods</h4>One thousand seven hundred and sixteen ST users wanting to quit were recruited online to the MyLastDip program and randomly assigned to one of two fully automated web-based ST cessation intervent ...[more]

PMID: 23410803

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Project description:BACKGROUND:Use of smokeless tobacco (moist snuff and chewing tobacco) is a significant public health problem but smokeless tobacco users have few resources to help them quit. Web programs and telephone-based programs (Quitlines) have been shown to be effective for smoking cessation. We evaluate the effectiveness of a Web program, a Quitline, and the combination of the two for smokeless users recruited via the Web. OBJECTIVES:To test whether offering both a Web and Quitline intervention for smokeless tobacco users results in significantly better long-term tobacco abstinence outcomes than offering either intervention alone; to test whether the offer of Web or Quitline results in better outcome than a self-help manual only Control condition; and to report the usage and satisfaction of the interventions when offered alone or combined. METHODS:Smokeless tobacco users (N= 1,683) wanting to quit were recruited online and randomly offered one of four treatment conditions in a 2×2 design: Web Only, Quitline Only, Web + Quitline, and Control (printed self-help guide). Point-prevalence all tobacco abstinence was assessed at 3- and 6-months post enrollment. RESULTS:69% of participants completed both the 3- and 6-month assessments. There was no significant additive or synergistic effect of combining the two interventions for Complete Case or the more rigorous Intent To Treat (ITT) analyses. Significant simple effects were detected, individually the interventions were more efficacious than the control in achieving repeated 7-day point prevalence all tobacco abstinence: Web (ITT, OR = 1.41, 95% CI = 1.03, 1.94, p = .033) and Quitline (ITT: OR = 1.54, 95% CI = 1.13, 2.11, p = .007). Participants were more likely to complete a Quitline call when offered only the Quitline intervention (OR = 0.71, 95% CI = .054, .093, p = .013), the number of website visits and duration did not differ when offered alone or in combination with Quitline. Rates of program helpfulness (p <.05) and satisfaction (p <.05) were higher for those offered both interventions versus offered only quitline. CONCLUSION:Combining Web and Quitline interventions did not result in additive or synergistic effects, as have been found for smoking. Both interventions were more effective than a self-help control condition in helping motivated smokeless tobacco users quit tobacco. Intervention usage and satisfaction were related to the amount intervention content offered. Usage of the Quitline intervention decreased when offered in combination, though rates of helpfulness and recommendations were higher when offered in combination. TRIAL REGISTRATION:Clinicaltrials.gov NCT00820495; http://clinicaltrials.gov/ct2/show/NCT00820495.

Project description:BACKGROUND:The content of online computer-tailored interventions is often determined to match an individual's characteristics, beliefs, and behavioral factors. These content-tailored interventions lead to better message processing and a higher likelihood of behavior change such as smoking cessation. However, a meta-analysis of online computer-tailored interventions showed that effect sizes, albeit positive, remain small, suggesting room for improvement. A promising strategy to enhance the effectiveness of online computer-tailored interventions is to tailor the message frame (ie, how a message is communicated) based on the preferred communication style of the user in addition to content-tailoring. One factor that determines an individual's communication style preference is the need for autonomy; some individuals prefer an autonomy-supportive communication style (offering choice and use of suggestive language), whereas others might prefer a directive communication style, which is replete with imperatives and does not provide choice. Tailoring how messages are presented (eg, based on the need for autonomy) is called message frame-tailoring. OBJECTIVE:The aim of the present study was to test the effectiveness of message frame-tailoring based on the need for autonomy, in isolation and in combination with content-tailoring, within the context of an online computer-tailored smoking cessation intervention. The primary outcome measure was the 7-day point-prevalence of smoking abstinence. Secondary outcomes were perceived message relevance, self-determined motivation to quit smoking, and sociocognitive beliefs. METHODS:A randomized controlled trial with a 2 (message frame-tailoring vs no message frame-tailoring) by 2 (content-tailoring vs no content-tailoring) design was conducted among adult smokers intending to quit smoking (N=273). RESULTS:Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02). However, neither message frame-tailoring nor its interaction with content-tailoring significantly predicted smoking abstinence. In our model, message frame-tailoring, content-tailoring, as well as their interaction significantly predicted perceived relevance of the smoking cessation messages, which consequently predicted self-determined motivation. In turn, self-determined motivation positively affected attitudes and self-efficacy for smoking cessation, but only self-efficacy consequently predicted smoking abstinence. Participants in the control condition perceived the highest level of message relevance (mean 4.78, SD 1.27). However, messages that were frame-tailored for individuals with a high need for autonomy in combination with content-tailored messages led to significantly higher levels of perceived message relevance (mean 4.83, SD 1.03) compared to those receiving content-tailored messages only (mean 4.24, SD 1.05, P=.003). CONCLUSIONS:Message frame-tailoring based on the need for autonomy seems to be an effective addition to conventional content-tailoring techniques in online smoking cessation interventions for people with a high need for autonomy; however, this is not effective in its current form for people with a low need for autonomy. TRIAL REGISTRATION:Dutch Trial Register (NL6512/NRT-6700); https://www.trialregister.nl/trial/6512.

Project description:IntroductionPartner behaviors and attitudes can motivate or undermine a tobacco user's cessation efforts. We developed a multimedia intervention, UCare (Understanding-CAring-REspect) for women who wanted their male partner to quit smokeless tobacco (ST), based on perceived partner responsiveness-the empirically based theory that support is best received when the supporter conveys respect, understanding, and caring.MethodsOne thousand one hundred three women were randomized to receive either immediate access to the UCare website and printed booklet (Intervention; N = 552), or a Delayed Treatment control (N = 551). We assessed supportive behaviors and attitudes at baseline and 6-week follow-up, and the ST-using partner's abstinence at 6 weeks and 7.5 months (surrogate report).ResultsFor partners of women assigned to Intervention, 7.0% had quit all tobacco at 7.5 months, compared with 6.6% for control (χ2 (1, n = 1088) = .058, p = .810). For partners of women completing the intervention, 12.4% had quit all tobacco at 7.5 months, compared with 6.6% for Delayed Treatment (χ2 (1, n = 753) = 6.775, p = .009). A previously reported change in responsiveness-based behaviors and instrumental behaviors at 6 weeks mediated 7.5-month cessation, and change in responsiveness-based attitudes mediated the change in responsiveness-based behaviors, indirectly increasing cessation.ConclusionsA responsiveness-based intervention with female partners of male ST users improved supportive attitudes and behaviors, leading to higher cessation rates among tobacco users not actively seeking to quit. The study demonstrates the potential for responsiveness as a basis for effective intervention with supporters. This approach may reach tobacco users who would not directly seek help.ImplicationsThis study demonstrates the value of a responsiveness-based intervention (showing respect, understanding, and caring) in training partners to provide support for a loved one to quit ST. In a randomized clinical trial, 1,103 women married to or living with a ST user were randomized to receive the UCare-ChewFree intervention (website + booklet) or a Delayed Treatment control. Women completing the intervention were more likely to improve their behaviors and attitudes, and change in behaviors and attitudes mediated cessation outcomes for their partners, who had not enrolled in the study and may not have been seeking to quit.Trial registrationClinicalTrials.gov NCT01885221.

Project description:IntroductionThe U.S. Food and Drug Administration (FDA) is required by law to inform the public about levels of harmful and potentially harmful tobacco constituents in a format that is "understandable and not misleading to a lay person." Our study addresses a critical gap in research on communicating such information for smokeless tobacco (SLT) products.MethodsThe design included random assignment to one of the experimental (online interactive) conditions differing in presentation format or a control condition (receiving no information). Experimental respondents viewed information on levels and health risks of 5 harmful constituents in up to 79 products. Outcome measures included knowledge of health risks of constituents, perception of constituent variability in SLT products, disease risk ratings, self-reported SLT use, and side-by-side product comparisons. The sample of 333 SLT users, 535 cigarette smokers, and 663 nontobacco users participated at baseline, time of intervention, and 6 weeks postintervention.ResultsPresentation formats showed few systematic differences so were combined in analyses. Experimental condition respondents increased their knowledge about constituent health effects and their perceptions of constituent variability in SLT products, from baseline to postintervention, and relative to the control condition. Changes in respondents' ratings of disease risk and their estimates of constituent exposure from specific products were observed, but not in self-reported SLT use.ConclusionsInteractive online graphic and numeric presentation formats can be efficient in increasing people's knowledge of health effects and perceived variation of constituents in SLT products. Further research on longer-term behavioral assessment, and usefulness of this approach for regulatory agencies, is needed.ImplicationsResearch on communicating the information about harmful constituents in SLT products to lay persons is critically lacking. This study proposes novel formats for effective communication about the levels and the health effects of SLT constituents to multiple user groups. The lack of misperceptions among study participants that some tobacco products are safe suggests that such formats can potentially be used for public display of SLT constituent data by the FDA and regulatory agencies in other countries.

Project description:IntroductionNicotine replacement medications are moderately effective in increasing quit rates. However, some smokers reject such aids, suggesting the value of considering alternative options. Snus, a smokeless tobacco product with low nitrosamine content, could offer an alternative. This study compared smoking cessation rates for snus, with and without information about reduced risk relative to smoking, with a nicotine lozenge (without relative risk information).MethodsA randomized, open-label, multicenter clinical trial was performed with 649 smokers, aged 21 to 65, who smoked at least 10 cigarettes per day for the past year and who were motivated to quit smoking. Participants were followed for up to 12 months and were provided no counseling or support. Smoking cessation was analyzed as continuous smoking abstinence (no smoking following quit date) and repeated point prevalence abstinence (no smoking within past 7 days).ResultsAbstinence rates did not differ significantly between snus and the nicotine lozenge-continuous abstinence did not differ at any time point, and point prevalence rates differed only at month 3, when the lozenge group showed higher abstinence rates (17.4%) than either of the two snus groups (snus alone: 8.7%; snus plus information: 10.1%). Large percentages of participants used the products during the treatment period. Providing relative risk information to snus users did not affect snus use. The amount of use did not predict subsequent outcome. Adverse events were reported at similar rates across the three groups.ConclusionsSmoking cessation rates were comparable between snus and a nicotine lozenge, but success rates in this trial were low.ImplicationsThis randomized trial of the nicotine lozenge, snus, or snus plus information on the relative risks of smokeless tobacco versus smoking found comparable but low smoking cessation rates for all three groups at weeks 12, 26, and 52. The one-time provision of relative risk information did not lead to greater snus use among those provided the information, suggesting no effect for this brief intervention.

Project description:BACKGROUND: This observational study assessed the relation between mass media campaigns and service volume for a statewide tobacco cessation quitline and stand-alone web-based cessation program. METHODS: Multivariate regression analysis was used to identify how weekly calls to a cessation quitline and weekly registrations to a web-based cessation program are related to levels of broadcast media, media campaigns, and media types, controlling for the impact of external and earned media events. RESULTS: There was a positive relation between weekly broadcast targeted rating points and the number of weekly calls to a cessation quitline and the number of weekly registrations to a web-based cessation program. Additionally, print secondhand smoke ads and online cessation ads were positively related to weekly quitline calls. Television and radio cessation ads and radio smoke-free law ads were positively related to web program registration levels. There was a positive relation between the number of web registrations and the number of calls to the cessation quitline, with increases in registrations to the web in 1 week corresponding to increases in calls to the quitline in the subsequent week. Web program registration levels were more highly influenced by earned media and other external events than were quitline call volumes. CONCLUSION: Overall, broadcast advertising had a greater impact on registrations for the web program than calls to the quitline. Furthermore, registrations for the web program influenced calls to the quitline. These two findings suggest the evolving roles of web-based cessation programs and Internet-use practices should be considered when creating cessation programs and media campaigns to promote them. Additionally, because different types of media and campaigns were positively associated with calls to the quitline and web registrations, developing mass media campaigns that offer a variety of messages and communicate through different types of media to motivate tobacco users to seek services appears important to reach tobacco users. Further research is needed to better understand the complexities and opportunities involved in simultaneous promotion of quitline and web-based cessation services.

Dataset Information

Randomized controlled trial of MyLastDip: a Web-based smokeless tobacco cessation program for chewers ages 14-25.

Publications

Randomized controlled trial of MyLastDip: a Web-based smokeless tobacco cessation program for chewers ages 14-25.

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