Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial.

BACKGROUND: Evidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs. OBJECTIVE: To examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA). DESIGN: Randomized controlled trial. (ClinicalTrials.gov: NCT02653768). SETTING: 2 U.S. Department of Veterans Affairs sites. PARTICIPANTS: 345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis. INTERVENTION: Participants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks. MEASUREMENTS: Primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models. RESULTS: In the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, -10.5 to -3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement. LIMITATION: Participants were mostly male veterans, and follow-up was limited. CONCLUSION: Veterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis. PRIMARY FUNDING SOURCE: Department of Veterans Affairs, Health Services Research and Development Service.

Effect of a Responsiveness-Based Support Intervention on Smokeless Tobacco Cessation: The UCare-ChewFree Randomized Clinical Trial.

INTRODUCTION: Partner 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. METHODS: One 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). RESULTS: For 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. CONCLUSIONS: A 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. IMPLICATIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT01885221.

Very Low Nicotine Content Cigarettes Disrupt the Feedback Loop of Affective States and Smoking Behavior.

INTRODUCTION: Smoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period. AIMS AND METHODS: Participants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group. RESULTS: We found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure. CONCLUSIONS: Our results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking. IMPLICATIONS: These findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.

STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial.

BACKGROUND: Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions. METHODS / DESIGN: Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA. DISCUSSION: STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.

Level of participation in physical therapy or an internet-based exercise training program: associations with outcomes for patients with knee osteoarthritis.

BACKGROUND: To examine whether number of physical therapy (PT) visits or amount of use of an internet-based exercise training (IBET) program is associated with differential improvement in outcomes for participants with knee osteoarthritis (OA). METHODS: A secondary analysis was performed using data from participants in 2 arms of a randomized control trial for individuals with symptomatic knee OA: PT (N = 135) or IBET (N = 124). We examined associations of number of PT visits attended (up to 8) or number of days the IBET website was accessed during the initial 4-month study period with changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, pain and function subscales, as well as a 2-min Step Test, at 4-month and 12-month follow-up. RESULTS: Participants with more PT visits experienced greater improvement in WOMAC total score (estimate per additional visit = - 1.18, CI 95% = - 1.91, 0.46, p <  0.001) and function subscore (estimate = - 0.80, CI 95% = - 1.33, - 0.28, p <  0.001) across follow-up periods. For WOMAC pain subscale, the association with number of PT visits varied significantly between 4- and 12-month follow-up, with a stronger relationship at 4-months. There was a non-significant trend for more PT visits to be associated with greater improvement in 2-min Step Test. More frequent use of the IBET website was not associated with greater improvement for any outcome, at either time point. CONCLUSION: Increased number of PT visits was associated with improved outcomes, and some of this benefit persisted 8 months after PT ended. This provides guidance for PT clinical practice and policies. TRIAL REGISTRATION: NCT02312713 , posted 9/25/2015.

Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial.

Importance: The optimal temporal approach for reducing nicotine to minimally or nonaddictive levels in all cigarettes sold in the United States has not been determined. Objectives: To determine the effects of immediate vs gradual reduction in nicotine content to very low levels and as compared with usual nicotine level cigarettes on biomarkers of toxicant exposure. Design, Setting, and Participants: A double-blind, randomized, parallel-design study with 2 weeks of baseline smoking and 20 weeks of intervention was conducted at 10 US sites. A volunteer sample of daily smokers with no intention to quit within 30 days was recruited between July 2014 and September 2016, with the last follow-up completed in March 2017. Interventions: (1) Immediate reduction to 0.4 mg of nicotine per gram of tobacco cigarettes; (2) gradual reduction from 15.5 mg to 0.4 mg of nicotine per gram of tobacco cigarettes with 5 monthly dose changes; or (3) maintenance on 15.5 mg of nicotine per gram of tobacco cigarettes. Main Outcomes and Measures: Between-group differences in 3 co-primary biomarkers of smoke toxicant exposure: breath carbon monoxide (CO), urine 3-hydroxypropylmercapturic acid (3-HPMA, metabolite of acrolein), and urine phenanthrene tetraol (PheT, indicator of polycyclic aromatic hydrocarbons) calculated as area under the concentration-time curve over the 20 weeks of intervention. Results: Among 1250 randomized participants (mean age, 45 years; 549 women [44%]; 958 [77%] completed the trial), significantly lower levels of exposure were observed in the immediate vs gradual reduction group for CO (mean difference, -4.06 parts per million [ppm] [95% CI, -4.89 to -3.23]; P < .0055), 3-HPMA (ratio of geometric means, 0.83 [95% CI, 0.77 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.88 [95% CI, 0.83 to 0.93]; P < .0055). Significantly lower levels of exposure were observed in the immediate reduction vs control group for CO (mean difference, -3.38 [95% CI, -4.40 to -2.36]; P < .0055), 3-HPMA (ratio of geometric means, 0.81 [95% CI, 0.75 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.86 [95% CI, 0.81 to 0.92]; P < .0055). No significant differences were observed between the gradual reduction vs control groups for CO (mean difference, 0.68 [95% CI, -0.31 to 1.67]; P = .18), 3-HPMA (ratio of geometric means, 0.98 [95% CI, 0.91 to 1.06]; P = .64), and PheT (ratio of geometric means, 0.98 [95% CI, 0.92 to 1.04]; P = .52). Conclusions and Relevance: Among smokers, immediate reduction of nicotine in cigarettes led to significantly greater decreases in biomarkers of smoke exposure across time compared with gradual reduction or a control group, with no significant differences between gradual reduction and control. Trial Registration: clinicaltrials.gov Identifier: NCT02139930.

Prevalence and Correlates of Late Initiation of Smokeless Tobacco in US Firefighters.

INTRODUCTION: Prevalence rates of smokeless tobacco (SLT) use and late initiation among firefighters (ie, starting use as an adult after joining the fire service) are remarkably high, 10.5% and 26.0%, respectively. The purpose of this study is to examine characteristics associated with late SLT initiation in a sample comprised of male career firefighters from two large cohort studies. METHODS: We examined correlates of late SLT initiation in a secondary analysis of data combining the baseline evaluations of two published firefighter health studies with 1474 male career firefighters in the United States. RESULTS: Fourteen percent of participants were current SLT users. Among this group, the unadjusted rate of firefighters who initiated SLT use after joining the fire service was 15.9%, while the age-standardized rate was 38.2%; this is substantially higher than the national adjusted late initiation rate among adult males (0.8%). In addition, firefighters demonstrated higher rates of late SLT initiation (15.9% unadjusted; 18.4% age-standardized) when compared to males in the military overall (13.8%). CONCLUSIONS: The exceptionally high prevalence of SLT use overall and late initiation in the fire service suggest that joining the fire service in the United States is a risk factor for SLT use. There is a need to develop interventions aimed at reducing SLT use in the fire service that are specifically tailored for this occupational group. IMPLICATIONS: The high prevalence of late SLT initiation (ie, starting use as an adult after joining the fire service) among firefighters should be addressed by both researchers and fire service organizations given the significant health risks associated with SLT and its impact on occupational readiness. There is a need for developing intervention programs aimed at reducing SLT use in the fire service. Interventions would need to be specifically tailored for this occupational group and their unique culture, given that joining the fire service appears to be a risk factor for SLT initiation among firefighters who did not use tobacco prior to joining the fire service.

Utility of Responsiveness Theory for Classifying Supportive Behaviors to Enhance Smokeless Tobacco Cessation.

INTRODUCTION: Although social support is correlated with successful tobacco cessation, interventions designed to optimize social support have shown mixed results. Understanding the process of providing social support for tobacco cessation may suggest new approaches to intervention. Responsiveness theory provides a new framework for classifying supportive behaviors in the context of tobacco cessation. It proposes three main components to sustaining relationship quality when providing support to an intimate partner: showing respect, showing understanding, and showing caring. METHODS: Interviews were conducted with 35 women whose husbands or domestic partners had quit smokeless tobacco and were analyzed within a responsiveness theory framework: Positive and negative instances of the three supportive components were expressed in terms of beliefs and attitudes, interactions with the chewer, and behaviors outside of the interaction context. RESULTS: Positive activities included respecting the chewer's decision on whether, when, and how to quit; perspective-taking and other efforts to understand his subjective experience; and expressing warmth and affection toward the chewer. Particularly problematic for the women were the challenges of respecting the chewer's autonomy (ie, negative behaviors such as nagging him to quit or monitoring his adherence to his cessation goal) and lack of understanding the nature of addiction. CONCLUSIONS: The findings help to confirm the potential utility of responsiveness theory for elucidating the breadth of both positive and negative forms of partner support that may be useful to guide social support interventions for tobacco cessation. IMPLICATIONS: The study provides a categorization system for positive and negative social support during smokeless tobacco cessation, based on responsiveness theory and interviews with 35 partners of smokeless users.

Nicotine Metabolite Ratio Is Associated With Lozenge Use But Not Quitting in Smokeless Tobacco Users.

INTRODUCTION: The nicotine metabolite ratio (NMR) of 3'-hydroxycotinine to cotinine is a noninvasive marker of the rate of nicotine metabolism. Fast metabolism (ie, a high NMR) is associated with lower cigarette smoking abstinence rates using transdermal nicotine replacement. We evaluated whether the NMR can be used to predict self-reported nicotine lozenge use and tobacco abstinence among smokeless tobacco users treated for tobacco dependence. METHODS: This was a secondary analysis of data from one arm of a large trial. Participants received quitting support materials and 4-mg nicotine lozenges by mail plus three coaching phone calls. Saliva kits were mailed for collection of saliva samples, which were analyzed for cotinine and 3'-hydroxycotinine. Self-reported tobacco and lozenge use were assessed at 3 months. Analyses were performed using Spearman rank correlation and logistic regression. RESULTS: Of the 160 saliva collection kits mailed, 152 were returned. The NMR was not significantly correlated with the baseline amount of smokeless tobacco used, the number of years of tobacco use, or the level of tobacco dependence as measured by the Severson Smokeless Tobacco Dependency Scale. The NMR was positively correlated with lozenge use (r = 0.21, P = .015), but it did not predict self-reported 7-day point prevalence abstinence at 3 months. CONCLUSIONS: Fast metabolizers may need to self-administer more nicotine replacement in the form of nicotine lozenges to achieve the same clinical response achieved by slower metabolizers using fewer lozenges.

Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching.

BACKGROUND: An essential component of evaluating potential modified risk tobacco products is to determine how consumers use the product and resulting effects on biomarkers of toxicant exposure. STUDY DESIGN: Cigarette smokers (n=391) recruited in Minnesota and Oregon were randomised to either snus or 4 mg nicotine gum for 12 weeks. Participants were instructed to completely switch from cigarettes to these products. Urine samples were collected to analyse for carcinogenic tobacco-specific nitrosamine metabolites (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and N'-nitrosonornicotine and their glucuronides) and nicotine metabolites (total cotinine and nicotine equivalents) levels. RESULTS: Of the 391 participants randomised, 52.9% were male, the mean±SD age was 43.9±12.5 years, baseline number of cigarettes/day was 18.0±6.5 and Fagerstrom Test for Nicotine Dependence score was 5.1±2.0. The mean±SD number of snus pouches used/week at week 6 prior to tapering was 39.1±24.0 and nicotine gum pieces used was 37.6±26.3. Dual use of cigarettes and these products were observed in 52.9% and 58.2% of those assigned to snus and nicotine gum, respectively, at week 12. The end of treatment biochemically verified (carbon monoxide, CO<6 ppm) 7-day avoidance of cigarettes was 21.9% in the snus group and 24.6% in the nicotine gum group. Toxicant exposure in the nicotine gum group was significantly less when compared to snus. CONCLUSIONS: Snus performed similarly to nicotine gum in cigarette smokers who were interested in completely switching to these products, but was associated with less satisfaction and greater toxicant exposure than nicotine gum. TRIAL REGISTRATION NUMBER: NCT: 00710034.

Randomized trial of nicotine lozenges and phone counseling for smokeless tobacco cessation.

INTRODUCTION: Relatively few treatment programs have been developed specifically for smokeless tobacco (ST) users who want to quit. Their results suggest that self-help materials, telephone counseling, and nicotine lozenges are efficacious. This study provides the first direct examination of the separate and combined effects of telephone counseling and lozenges. METHODS: We recruited ST users online (N = 1067) and randomly assigned them to 1 of 3 conditions: (a) a lozenge group (n = 356), who were mailed 4-mg nicotine lozenges; (b) a coach calls group (n = 354), who were offered 3 coaching phone calls; or (c) a lozenge + coach calls group (N = 357), who received both lozenges and coaching calls. Additionally, all participants were mailed self-help materials. Self-reported tobacco abstinence was assessed at 3 and 6 months after randomization. RESULTS: Complete-case and intention-to-treat (ITT) analyses for all tobacco abstinence were performed at 3 months, 6 months, and both 3 and 6 months (repeated point prevalence). ITT analyses revealed a highly similar result: the lozenge + coach calls condition was significantly more successful in encouraging tobacco abstinence than either the lozenge group or the coach calls group, which did not differ. CONCLUSIONS: Combining nicotine lozenges and phone counseling significantly increased tobacco abstinence rates compared with either intervention alone, whereas coach calls and lozenges were equivalent. The study confirms the high tobacco abstinence rates for self-help ST cessation interventions and offers guidance to providing tobacco treatment to ST users.

Web-based therapeutic exercise resource center as a treatment for knee osteoarthritis: a prospective cohort pilot study.

BACKGROUND: Although beneficial effects of exercise in the management of knee osteoarthritis (OA) have been established, only 14 -18% of patients with knee OA receive an exercise from their primary care provider. Patients with knee OA cite lack of physician exercise advice as a major reason why they do not exercise to improve their condition. The purpose of this pilot study was to investigate use of a web-based Therapeutic Exercise Resource Center (TERC) as a tool to prescribe strength, flexibility and aerobic exercise as part of knee OA treatment. It was hypothesized that significant change in clinical outcome scores would result from patients' use of the TERC. METHODS: Sixty five individuals diagnosed with mild/moderate knee OA based on symptoms and radiographs were enrolled through outpatient physician clinics. Using exercise animations to facilitate proper technique, the TERC assigned and progressed patients through multiple levels of exercise intensity based on exercise history, co-morbidities and a validated measure of pain and function. Subjects completed a modified short form WOMAC (mSF-WOMAC), World Health Organization Quality of Life (WHO-QOL) and Knee Self-Efficacy Scale (K-SES) at baseline and completion of the 8 week program, and a user satisfaction survey. Outcomes were compared over time using paired t-tests and effect sizes calculated using partial point biserial (pr). RESULTS: Fifty two participants completed the 8 week program with average duration of knee pain 8.0 ± 11.0 yrs (25 females; 61.0 ± 9.4 yrs; body mass index, 28.8 ± 6.3 kg/m2). During the study period, all outcome measures improved: mSF-WOMAC scores decreased (better pain and function) (p<.001; large effect, pr=0.70); WHO-QOL physical scores increased (p=.015; medium effect, pr=0.33); and K-SES scores increased (p<.001; large effect, pr=0.54). No significant differences were found in study outcomes as a function of gender, age, BMI or symptom duration. Patients reported very positive evaluation of the TERC (94% indicated the website was easy to use; 90% specified the exercise animations were especially helpful). CONCLUSION: This pilot study demonstrated the web-based TERC to be feasible and efficacious in improving clinical outcomes for patients with mild/moderate knee OA and supports future studies to compare TERC to current standard of care, such as educational brochures.

Effect of nicotine replacement therapy on quitting by young adults in a trial comparing cessation services.

CONTEXT: Young adult smokers have the highest smoking prevalence among all US age groups but are least likely to use evidence-based cessation counseling or medication to quit. OBJECTIVE: Use and effectiveness of nicotine patch were explored in a randomized trial evaluating smoking cessation interventions with this population. PARTICIPANTS: Smokers aged 18 to 30 (n = 3094) were recruited through online and off-line methods and from telephone quit lines and analyzed. DESIGN: Smokers were enrolled in a pretest-posttest trial, and randomized to 1 of 3 cessation services. SETTING: Trial delivering counseling services by self-help booklet, telephone quit lines, or online expert system in the 48 continental United States. INTERVENTION: Smokers could request a free 2-week course of nicotine replacement therapy (NRT) patches from the project. MAIN OUTCOME MEASURE: Follow-up surveys at 12 and 26 weeks assessed smoking abstinence, use of NRT, counseling, and other cessation medications, and smoking-related variables. RESULTS: Overall, 69.0% of smokers reported using NRT (M = 3.2 weeks) at 12 weeks and 74.8% (M = 3.3 weeks) at 26 weeks. More smokers who were sent the free nicotine patches (n = 1695; 54.8%) reported using NRT than those who did not receive them (12 weeks: 84.3% vs 41.9%, P < .001; 26 weeks: 87.6% vs 51.1%, P < .001). The use of NRT was associated with greater smoking abstinence at 12 weeks (P < .001) and 26 weeks (P < .05), especially if used for more than 2 weeks (P < .001). Smokers assigned to a self-help booklet or cessation Web site and heavier smokers were most likely to use NRT (P < .05), whereas those reporting marijuana use and binge drinking used NRT less (P < .05). CONCLUSIONS: Many young adults were willing to try NRT, and it appeared to help them quit in the context of community-based cessation services. Strategies should be developed to make NRT available to this age group and support them in using it to prevent lifelong smoking.

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

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.

Evaluation of a theory-driven e-learning intervention for future oral healthcare providers on secondary prevention of disordered eating behaviors.

Oral healthcare providers have a clinical opportunity for early detection of disordered eating behaviors because they are often the first health professionals to observe overt oral and physical signs. Curricula regarding early recognition of this oral/systemic medical condition are limited in oral health educational programs. Web-based learning can supplement and reinforce traditional learning and has the potential to develop skills. The study purpose was to determine the efficacy of a theory-driven Web-based training program to increase the capacity of oral health students to perform behaviors related to the secondary prevention of disordered eating behaviors. Using the Reach, Effectiveness, Adoption, Implementation and Maintenance evaluation framework, a longitudinal group-randomized controlled trial involving 27 oral health classes from 12 oral health education programs in the United States was implemented to assess the efficacy of the Web-based training on attitudes, knowledge, self-efficacy and skills related to the secondary prevention of disordered eating behaviors. Mixed-model analysis of covariance indicated substantial improvements among students in the intervention group (effect sizes: 0.51-0.83) on all six outcomes of interest. Results suggest that the Web-based training program may increase the capacity of oral healthcare providers to deliver secondary prevention of disordered eating behaviors. Implications and value of using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework are discussed.

A pilot study of the efficacy of varenicline for the treatment of smokeless tobacco users in Midwestern United States.

INTRODUCTION: Long-term smokeless tobacco (ST) use is known to increase the risk for oropharyngeal cancer, heart attack, and stroke. Varenicline has recently been demonstrated to increase ST abstinence rates among Swedish snus users. We have conducted a pilot study to obtain preliminary evidence of efficacy of varenicline for the treatment of ST users in Midwestern United States. METHODS: We conducted a randomized, placebo-controlled Phase II clinical trial to evaluate the potential efficacy of 12 weeks of varenicline for the treatment of ST users with an a priori decision rule that a 1-tailed p < .20 for the comparison of the primary endpoint was evidence to conclude that future studies were warranted. Subjects were followed for 6 months after randomization. RESULTS: We randomized 76 subjects (38 varenicline and 38 placebo). Subjects were similar at baseline with a mean age of 41 years, and all were male. The biochemically confirmed point prevalence tobacco abstinence rates at end of treatment were 55.3% for varenicline and 42.1% for placebo (p = .126) and 47.4% and 31.6% (p = .080), respectively, at 6 months. Point prevalence ST abstinence rates at end of treatment for varenicline were 57.9% and 42.1% for placebo (p = .084) and 57.9% and 31.6% (p = .011), respectively, at 6 months. Varenicline was associated with significantly less craving compared with placebo. Varenicline was well tolerated with nausea and sleep disturbance being the most common side effects. CONCLUSIONS: Varenicline decreases craving and may be effective for increasing tobacco abstinence rates among ST users. Larger trials may be warranted to confirm these results.

Short-term efficacy of Click City®: Tobacco: changing etiological mechanisms related to the onset of tobacco use.

This paper described the short-term results from an ongoing randomized controlled efficacy study of Click City®: Tobacco, a tobacco prevention program designed for 5th graders, with a booster in sixth grade. Click City®: Tobacco is an innovative school-based prevention program delivered via an intranet, a series of linked computers with a single server. The components of the program target theoretically based and empirically supported etiological mechanisms predictive of future willingness and intentions to use tobacco and initiation of tobacco use. Each component was designed to change one or more etiological mechanisms and was empirically evaluated in the laboratory prior to inclusion in the program. Short-term results from 47 elementary schools (24 schools who used Click City®: Tobacco, and 23 who continued with their usual curriculum) showed change in intentions and willingness to use tobacco from baseline to 1-week following the completion of the 5th grade sessions. The results demonstrate the short-term efficacy of this program and suggest that experimentally evaluating components prior to including them in the program contributed to the efficacy of the program. The program was most efficacious for students who were most at risk.

Development and beta test of a smokeless tobacco cessation program for firefighters.

INTRODUCTION: The prevalence of smokeless tobacco (SLT) use among firefighters is substantially higher than the general population and similar occupational groups. Despite the significant health risks associated with SLT and its impact on occupational readiness, there are no occupationally-tailored SLT education or treatment programs for the fire service. The purpose of this study was to beta test QUIT SPIT!, a self-help SLT cessation program that is culturally tailored for the US fire service and firefighters who are interested in quitting. METHODS: After development and tailoring the QUIT SPIT! SLT cessation program for firefighters, the feasibility and acceptability of the program were evaluated in a sample of eleven SLT-using firefighters who wanted to quit. The primary outcome was a 7-day point prevalence of SLT abstinence measured at 4 and 12 weeks post-enrollment follow-up assessments. RESULTS: Four firefighters reported having quit SLT (7-days point prevalence) at follow-up at 12 weeks. Those who did not achieve SLT abstinence reported reductions in frequency and quantity in SLT use and demonstrated a decrease in nicotine dependence. Firefighters also reported being satisfied with the QUIT SPIT! cessation program. CONCLUSIONS: The results provide strong support for the feasibility and acceptability of the QUIT SPIT! in SLT-using firefighters interested in quitting. The findings provide critical information about the next steps for further development and evaluation of the QUIT SPIT! program.

A qualitative study to assess perceptions, barriers, and motivators supporting smokeless tobacco cessation in the US fire service.

While firefighters currently have low smoking rates, rates of smokeless tobacco (SLT) use among this population are remarkably high and substantially greater than similar occupational groups, and the general population. This study explored determinants associated with SLT use, barriers to cessation, and motivators for SLT cessation in the fire service. Key informant interviews were conducted in 23 career firefighters who were current (n = 14) and former (n = 9) SLT users from across the U.S. Discussions were recorded and independently coded according to questions and themes. Major themes that developed among firefighters regarding SLT use determinants included positive perceptions of SLT products, social influences from their peers and family members, acceptability of SLT use in the fire service, and a coping resource for job stress. Firefighters discussed several barriers to SLT cessation, including intrapersonal barriers such as SLT use habits and its dependency, concerns about withdrawal symptoms; and social-environmental barriers including lack of support from health and other services providers, and lack of enforcement of existing tobacco policies regarding SLT use. Firefighters also mentioned both internal and external motivators for cessation. Internal motivators included self-motivation and their health concerns while external motivators included friends and family support, incentives or rewards, and price of SLT products. Findings provide unique perspectives from firefighters on factors that influence SLT use and barriers and motivators to SLT cessation. These are insufficiently assessed and considered by the fire service organizations and their health care providers. Thus, the organizations must understand these issues in order to mitigate barriers and motivate the personnel to quit using SLT. Information gained from firefighters who were current and former SLT users can be used to develop an effective, culturally-tailored intervention that is acceptable to fire service personnel.

Support for a nicotine reduction policy among participants enrolled in a 20-week trial of very low nicotine content cigarettes.

INTRODUCTION: The Food and Drug Administration is considering a policy to drastically reduce the allowable nicotine content of cigarettes. The current study examined whether the policy implementation approach, i.e., either immediately reducing nicotine content to very low levels or gradually reducing nicotine content over an extended period, influences policy support among people who smoke cigarettes. METHODS: Adults who smoked daily were randomly assigned (double-blind) to an immediate nicotine reduction condition (0.4 mg/g nicotine cigarettes), a gradual nicotine reduction condition (15.5 to 0.4 mg/g), or a control condition (15.5 mg/g) for 20 weeks. Participants were asked if they would "support or oppose a law that reduced the amount of nicotine in cigarettes, to make cigarettes less addictive." Logistic regression analyses assessed if policy support was affected by treatment condition, demographic covariates, interest in quitting, and subjective cigarette effects. RESULTS: At Week 20 (N = 957 completers), 60.4% of participants supported the policy, 17.4% opposed, and 22.2% responded "Don't know." Policy support did not differ by treatment condition. Support was greater among those interested in quitting (OR = 3.37, 95% CI = 2.49, 4.55). Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18-24 (OR = 0.53, 95% CI = 0.28, 0.99). No other covariates were associated with policy support. CONCLUSIONS: The majority of participants supported a nicotine reduction policy. The implementation approach, immediate or gradual reduction, did not affect policy support. Participants interested in quitting smoking were more likely to support a nicotine reduction policy.