Dataset Information

Can the Public Be Educated About Constituents in Smokeless Tobacco? A Three-Wave Randomized Controlled Trial.

ABSTRACT:

Introduction

The 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.

Methods

The 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.

Results

Presentation 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.

Conclusions

Interactive 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.

Implications

Research 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.

SUBMITTER: Loken B

PROVIDER: S-EPMC7789948 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Can the Public Be Educated About Constituents in Smokeless Tobacco? A Three-Wave Randomized Controlled Trial.

Loken Barbara B Borgida Eugene E Wang Tzushuo T Madzelan Molly K MK Williams Allison L AL Hatsukami Dorothy D Stepanov Irina I

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20210101 1

<h4>Introduction</h4>The 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.<h4>Methods</h4>The design included random assignment to one of the experimental (online interactive) conditions differing in presentat ...[more]

PMID: 32010948

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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:ObjectiveTo assess the efficacy and safety of varenicline (a licensed cigarette smoking cessation aid) in helping users of smokeless tobacco to quit.DesignDouble blind, placebo controlled, parallel group, multicentre, randomised controlled trial.SettingMedical clinics (mostly primary care) in Norway and Sweden.ParticipantsMen and women aged ≥18 who used smokeless tobacco at least eight times a day, with no abstinence period over three months within one year before screening, who wanted to quit all tobacco use. Participants were excluded if they used any other form of tobacco (except smokeless tobacco) or medication to stop smoking within three months of screening or had any pre-existing medical or psychiatric condition.InterventionsVarenicline 1 mg twice daily (titrated during the first week) or placebo for 12 weeks, with 14 weeks' follow-up after treatment.Main outcome measuresThe primary end point was the four week continuous abstinence rate at the end of treatment (weeks 9-12) confirmed with cotinine concentration. A secondary end point was continuous abstinence rate for weeks 9-26. Safety and tolerability were also evaluated.Results431 participants (213 varenicline; 218 placebo) were randomised and received at least one dose of study drug. Participants' demographics and baseline use of smokeless tobacco were similar (89% (189) and 90% (196), respectively, were men; mean age in both groups was 43.9; participants used smokeless tobacco products about 15 times a day, and about 80% first used smokeless tobacco within 30 minutes after awakening). Continuous abstinence rate at week 9-12 was higher in the varenicline group than the placebo group (59% (125) v 39% (85); relative risk 1.60, 95% confidence interval 1.32 to 1.87, P<0.001; risk difference 20%; number needed to treat 5). The advantage of varenicline over placebo persisted through 14 weeks of follow-up (continuous abstinence rate at week 9-26 was 45% (95) v 34% (73); relative risk 1.42, 1.08 to 1.79, P=0.012; risk difference 11%; number needed to treat 9). The most common adverse events in the varenicline group compared with the placebo group were nausea (35% (74) v 6% (14)), fatigue (10% (22) v 7% (15)), headache (10% (22) v 9% (20)), and sleep disorder (10% (22) v 7% (15)). Few adverse events led to discontinuation of treatment (9% (19) and 4% (9), respectively), and serious adverse events occurred in two (1%) and three (1%) participants, respectively.ConclusionVarenicline can help people to give up smokeless tobacco and has an acceptable safety profile. The response rate in the placebo group in this study was high, suggesting a population less resistant to treatment than smokers.Trial registrationNCT00717093.

Project description:IntroductionDespite the high burden of tobacco use in India, users do not have access to adequate help. This pilot trial aimed to evaluate the feasibility and acceptability of a text messaging intervention for tobacco cessation, generate preliminary estimates of its impact, and fine-tune procedures for a definitive trial.Aims and methodsParallel two-arm single blind individually randomized controlled pilot trial with nested qualitative study. Participants included adult current tobacco users (smoked and smokeless). Eligible and consenting participants were randomized to receive either (1) text messaging intervention (ToQuit) which covered specific content areas such as psychoeducation about consequences of tobacco use and benefits of quitting and tobacco avoidance strategies or (2) information about tobacco cessation helplines such as the helpline number and the languages in which tobacco cessation support was available (control). Feasibility data included screening and consent rates, treatment dropouts, and outcome ascertainment. The primary abstinence outcome was self-reported abstinence from tobacco in the past seven days at 3 months post-randomization. In-depth interviews were conducted with a subsample of participants primarily to collect acceptability data. The primary abstinence analysis used a chi-squared test and logistic regression (complete case), and qualitative data was analyzed using thematic analysis.ResultsNinety-eight participants were randomized into the two trial arms; 77 (79%) completed outcome evaluation. No between-arm differences in abstinence were found though findings favored the intervention (7-day abstinence: ToQuit 23%, control 19%; adjusted odds ratio 1.23, 95% confidence interval 0.38, 3.97). Participants appreciated the language, comprehensibility, and relevance of the messages; and reported overall satisfaction with and positive impact from the intervention on their lives.ConclusionsThe findings indicate the acceptability and feasibility of ToQuit and if found effective, it could be a potentially scalable first-line response to tobacco use in low-resource settings.ImplicationsOur pilot randomized control trial provides sufficient findings supporting the acceptability and feasibility of an intervention for tobacco cessation which is suitable for a context which has a shortage of healthcare workers and for individuals who use smoked or smokeless tobacco. This is critical on a background of limited contextually relevant interventions for a problem with a high burden in low- and middle-income countries such as India.

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:There have been recent surges in the use of smokeless tobacco (SLT) and betel quid (BQ) chew among adolescents in South East Asian countries, with an increase, on average, of 7% to 15% between 2004 and 2013, necessitating interventional investigations to modify this behavior. The current intervention was aimed towards changing adolescents' perceptions regarding the harmful effects of SLT and BQ use and encouraging them to quit. This randomized control trial involved 2140 adolescents from 26 private and public-sector schools in Karachi, Pakistan. After randomization, 1185 individuals were placed in the intervention group and administered a behavior changing intervention (BCI), while 955 individuals constituted the control group. A generalized estimating equation was employed to measure differences in repeated measures for both groups. The beta coefficients were reported after adjusting the covariates with the 95% confidence interval, and the p-value was considered significant at <0.050. Cohen's d was employed to report the effect size of the intervention. The BCI resulted in a 0.176-unit (95% CI 0.078-0.274, p-value <0.001) increase in knowledge scores regarding the health hazards of SLT and BQ, a 0.141-unit (95% CI 0.090-0.192, p-value <0.001) increase in use perception scores, and a 0.067-unit (95% CI 0.006-0.129, p-value 0.031) increase in quit perception scores in the intervention group compared with those in the control group. A knowledge related module (p-value 0.024) and quit preparation module (p-value 0.005) were found to be helpful by adolescents in either changing their perceptions regarding SLT and/or BQ chew use or in quitting. The role of BCI is promising in improving adolescents' knowledge and changing their perceptions in a positive manner regarding their harmful SLT and BQ use. Convincing results may be achieved if interventions are tailored, with an emphasis on the identification of the products that are used by adolescents in addition to highlighting their ill effects and how students may manage to quit them. If included in the schools' curricula, this BCI method may help in developing schools that are free of SLT and BQ use. Trial registration: ClinicalTrials.gov NCT03488095.

Dataset Information

Can the Public Be Educated About Constituents in Smokeless Tobacco? A Three-Wave Randomized Controlled Trial.

Introduction

Methods

Results

Conclusions

Implications

Publications

Can the Public Be Educated About Constituents in Smokeless Tobacco? A Three-Wave Randomized Controlled Trial.

Similar Datasets

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