Race differences in predictors of weight gain among a community sample of smokers enrolled in a randomized controlled trial of a multiple behavior change intervention.

African Americans have disproportionate rates of post-cessation weight gain compared to non-Hispanic whites, but few studies have examined this weight gain in a multiracial sample of smokers receiving evidence-based treatment in a community setting. We examined race differences in short-term weight gain during an intervention to foster smoking cessation plus weight management. Data were drawn from the Best Quit Study, a randomized controlled trial conducted via telephone quitlines across the U.S. from 2013 to 2017. The trial tested the effects on cessation and weight gain prevention of adding a weight control intervention either simultaneously with or sequentially after smoking cessation treatment. African Americans (n = 665) and whites (n = 1723) self-reported smoking status and weight during ten intervention calls. Random effects longitudinal modeling was used to examine predictors of weight change over the intervention period (average 16 weeks). There was a significant race × treatment effect; in the simultaneous group, weight increased for African Americans at a faster rate compared to whites (b = 0.302, SE = 0.129, p < 0.05), independent of smoking status, age, baseline obesity, and education. After stratifying the sample, the effect of treatment group differed by race. Education level attenuated the rate of weight gain for African Americans in the simultaneous group, but not for whites. African Americans receiving smoking and weight content simultaneously gained weight faster than whites in the same group; however, the weight gain was slower for African Americans with higher educational attainment. Future studies are needed to understand social factors associated with treatment receptivity that may influence weight among African American smokers.

Marijuana Use and Adherence to Smoking Cessation Treatment Among Callers to Tobacco Quitlines.

INTRODUCTION: Tobacco kills over half a million adults annually in the United States. Most smokers want to quit, and over 400,000 call state-funded quitlines for help each year. Marijuana use among tobacco users is common and may impede quitting, but co-use rates among quitline callers are unknown. The purpose of our observational study was to describe marijuana use among quitline callers in states with legalized marijuana. METHODS: Participants were 1,059 smokers aged 21 or older from Oregon, Alaska, and Washington, DC, who called quitlines from September through December 2016. Data on quitline callers' demographics, tobacco and marijuana use, and quitline use were collected. We used χ2 and regression analyses to compare marijuana users with nonusers on demographic characteristics and quitline use. RESULT: Among quitline callers in our study, 24% reported using marijuana in the past 30 days: 28.9% in Alaska, 16.7% in Washington, DC, and 25.0% in Oregon (P = .009). Current users, compared with non-users (n = 772), were less likely to be women (48.4% vs 62.0%, respectively, P < .001). Current marijuana users were less likely to be given nicotine replacement therapy (68.4%) than current nonusers (74.1%) (P < .001), but more likely to complete 3 or more counseling calls (P = .005). Of those who used marijuana in the past 30 days, 62.3% used marijuana on 1 to 19 days, 9.0% used on 20 to 29 days, and 28.7% on all 30 days. Among current marijuana users, the percentage who wanted to quit or reduce marijuana use (42.6%) was higher in Alaska (54.6%) and the District of Columbia (56.8%) than in Oregon (37.9%), P = .03. CONCLUSION: One in 4 quitline callers reported past 30-day marijuana use. Given that nearly half (43%) wanted to reduce marijuana use, addressing co-use may be an important addition to quitline treatment. Future studies should assess co-use effects on tobacco cessation outcomes and explore combined treatment or bidirectional referrals between quitlines and marijuana treatment providers.

The impact of primary care behavioral health services on patient behaviors: A randomized controlled trial.

INTRODUCTION: Greater understanding of the impact of low intensity psychosocial interventions delivered by behavioral health clinicians (BHCs) working in an integrated care program (ICP) may promote better depression care. METHOD: In a randomized controlled trial, 153 participants identified as depressed by their primary care provider (PCP) were assigned to ICP or usual care (UC, management by PCP, including specialty referral). In the ICP condition, BHCs worked collaboratively with PCPs and liaison psychiatrists. RESULTS: ICP participants with lower and higher severity symptoms reported significantly greater use of coping strategies than UC participants at the 1-month follow up (lower: p = .002; higher: p = .016). ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups. ICP participants were more likely to be following relapse preventions plans at the 4-month follow up (lower: 89.5% vs. 50%, p = .0.000; higher 74.1% vs. 33%, p = .0001). ICP participants also reported use of antidepressant medications on more days than UC participants at the 4-month follow up (lower: 21.27 vs. 14.49 days, p = .049; higher: 24.61 vs. 17.08 days, p = .035). Patient retention in the ICP was high, and ICP participants were significantly more satisfied with depression care than UC participants at follow-up assessments. DISCUSSION: Delivery of low intensity psychosocial interventions by BHCs was associated with improvements to behavior charge targets. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial.

Smokers are at high risk of oral disease and report sub-optimal oral hygiene. Improving smokers' oral hygiene could reduce their future disease risk. The purpose of this study is to assess the effects of a novel, multi-modal oral health promotion program (Oral Health 4 Life; OH4L) targeted to socioeconomically disadvantaged smokers and delivered through state-funded tobacco quitlines. Smokers (n = 718) were randomized to standard quitline care or standard care plus OH4L. OH4L recipients received a comprehensive behavioral intervention and were advised of the benefits of routine oral hygiene, encouraged to brush and floss daily (for better oral health and to manage cigarette cravings), and provided a toothbrush and floss. Participants were followed for 6 months to assess the intervention effects on routine oral hygiene (brushing and flossing) and changes in motivation and self-efficacy. Data were collected between 2015 and 2017. At 2-month follow-up, OH4L participants were more likely to meet the American Dental Association (ADA) recommendations for brushing twice daily (adjusted RR = 1.15 [1.04, 1.27], p = .006), flossing daily (adjusted RR = 1.20 [1.03, 1.39], p = .02), and for both brushing and flossing (adjusted RR = 1.33 [1.10, 1.61], p = .003). Daily flossing was more likely at 6-month follow-up (adjusted RR = 1.21 [1.04, 1.42], p = .02) among OH4L participants. The change in self-efficacy and motivation for daily flossing from baseline to 2 months was significantly greater among OH4L participants and mediated the intervention effect on flossing at 6 months. Integrating oral hygiene promotion with standard tobacco quitline services improved oral health self-care.

Culturally-tailored text-messaging intervention for smoking cessation in rural American Indian communities: Rationale, design, and methods.

BACKGROUND: American Indian (AI) and Alaska Native (AN) communities experience disproportionately high rates of tobacco use when compared to the overall U.S. population, especially among rural populations. METHODS: We implemented a single-blind, randomized clinical trial of a text messaging-based smoking cessation intervention through the tobacco quitlines of five states (Alaska, Minnesota, New Mexico, Oklahoma, and Wisconsin) with high percentages of AI residents. We partnered with state quitlines and Optum, a multi-state entity that manages quitlines. Participants who called the quitlines and identified as AI/AN were given the option to enroll in this trial. Upon consent, they were randomly assigned to either the standard quitline program (control) or a program culturally tailored for AI/ANs (intervention), which used a text messaging intervention to encourage smoking cessation. We adapted the text messages based on key informant and focus group input. Baseline data was analyzed for differences across age, sex, and the Fagerström Test for Nicotine Dependence. RESULTS: We recruited n = 487 AIs into the trial. Participants had an average age of 41.9 years (SD = 11.7) and 66% were female. The average Fagerström Test for Nicotine Dependence score was 5.38 (SD = 2.37). The intervention and control arms did not significantly differ across any of the baseline characteristics. CONCLUSION: Implementation of this trial illustrated important lessons in adapting, implementing, and evaluating trials in collaboration with AI communities and local and national organizations. This work will inform future efforts to implement culturally-tailored interventions with AI/ANs and advance our knowledge about adapting and implementing smoking cessation interventions.

Six Month Abstinence Heterogeneity in the Best Quit Study.

BACKGROUND: Understanding the characteristics of smokers who are successful in quitting may help to increase smoking cessation rates. PURPOSE: To examine heterogeneity in cessation outcome at 6 months following smoking cessation behavioral counseling with or without weight management counseling. METHODS: 2,540 smokers were recruited from a large quitline provider and then randomized to receive proactive smoking cessation behavioral counseling without or with two versions of weight management counseling. A Classification and Regression Tree (CART) analysis was conducted to identify the individual pretreatment and treatment characteristics of groups of smokers with different quitting success (as measured by point prevalence of self-reported smoking of any amount at 6 months). RESULTS: CART analysis identified 10 subgroups ranging from 25.5% to 70.2% abstinent. The splits in the CART tree involved: the total number of counseling and control calls received, whether a smoking cessation pharmacotherapy was used, and baseline measures of cigarettes per day, confidence in quitting, expectation that the study would help the participant quit smoking, the motivation to quit, exercise minutes per week, anxiety, and lack of interest or pleasure in doing things. Costs per quitter ranged from a low of $US270 to a high of $US630. Specific treatment recommendations are made for each group. CONCLUSIONS: These results indicate the presence of a substantial variation in abstinence following treatment, and that the total extent of contact via counseling calls of any type and baseline characteristics, rather than assigned treatment, were most important to subgroup membership and abstinence. Tailored treatments to subgroups who are at high risk for smoking following a quit attempt could increase successful smoking cessation.

Specialized tobacco quitline and basic needs navigation interventions to increase cessation among low income smokers: Study protocol for a randomized controlled trial.

Smoking in the United States follows a clear socioeconomic gradient: low-income Americans smoke more and quit less than those with more education and income. Evidence-based interventions like tobacco quitlines are designed to make effective cessation services available on a population basis to all smokers. However, these interventions do not address many of the unique challenges faced by low-income smokers, including unmet basic needs like food, housing, personal safety and money for necessities that often supersede health needs. Research is needed to maximize the use and effectiveness of tobacco quitlines in low-income populations. This paper details the rationale, design and methods for a 2 × 2 randomized controlled trial currently underway comparing the effects of Standard and Specialized Tobacco Quitlines with and without Basic Needs Navigation on intervention engagement and smoking cessation among low-income smokers. Smokers are recruited from United Way 2-1-1 in Missouri and all participants receive tobacco quitline services from Optum. Quitline and navigation services are provided for 3 months. Participants complete telephone surveys at baseline, 3- and 6-month follow up. The primary study outcome is self-reported 7-day point prevalence abstinence at 6-month follow up. Embedding the study in practice agencies will accelerate dissemination and scalability should our findings demonstrate intervention effectiveness.

Predictors of engagement in post-discharge quitline counseling among hospitalized smokers.

Quitlines provide evidence-based tobacco treatment and multiple calls yield higher quit rates. This study aimed to identify subgroups of smokers with greater quitline engagement following referral during hospitalization. Data were from a randomized clinical trial assessing the effectiveness of fax referral (referral faxed to proactive quitline) versus warm handoff (patient connected to quitline at bedside) (n = 1054). Classification and regression trees analyses evaluated individual and treatment/health system-related variables and their interactions. Among all participants, warm handoff, higher ratings of the tobacco treatment care transition, and being older predicted completing more quitline calls. Among patients enrolled in the quitline, higher transition of care ratings, being older, and use of cessation medication post-discharge predicted completing more calls. Three of the four factors influencing engagement were characteristics of treatment within the hospital (quality of tobacco treatment care transition and referral method) and therapy (use of cessation medications), suggesting potential targets to increase quitline engagement post-discharge.

Factors associated with future dental care utilization among low-income smokers overdue for dental visits.

BACKGROUND: Smokers are at increased risk of oral disease. While routine dental care can help prevent and treat oral health problems, smokers have far lower rates of dental care utilization compared with non-smokers. We sought to better understand which factors may facilitate or hinder dental care utilization among low-income smokers participating in a randomized intervention trial in order to inform future intervention planning. METHODS: This is a secondary analysis of data collected between 2015 and 2017 as part of the OralHealth4Life trial. Participants were eligible callers to the Louisiana, Nebraska, and Oregon state tobacco quitlines who had no dental appointment in the prior or upcoming six months. We examined the association between participants' baseline characteristics and their receiving professional dental care between baseline and the 6-month follow-up survey. RESULTS: Participants were racially diverse (42% non-White) and two-thirds had an annual household income under $20,000. Most (86.7%) had not had a dental cleaning in more than one year. Commonly cited barriers to dental care included cost (83.7%) and no dental insurance (78.1%). Those with dental insurance were more likely to see a dentist at follow-up (RR 1.66). Similarly, those reporting a dental insurance barrier to care were less likely to see a dentist at follow-up (RR 0.69); however, there was no significant utilization difference between those reporting a cost barrier vs. those who did not. After controlling for these financial factors, the following baseline characteristics were significantly associated with a higher likelihood of dental care utilization at 6 months: higher motivation (RR 2.16) and self-efficacy (RR 1.80) to visit the dentist, having a disability (RR 1.63), having a higher education level (RR 1.52), and having perceived gum disease (RR 1.49). Factors significantly associated with a lower likelihood of dental care utilization included being married (RR 0.68) and not having a last dental cleaning within the past year (RR 0.47). CONCLUSIONS: Our findings provide important insight into factors that may facilitate or deter use of professional dental care among low-income smokers. This information could inform the development of future interventions to promote dental care utilization. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02347124 ; registered 27 January 2015.

Simultaneous vs. sequential treatment for smoking and weight management in tobacco quitlines: 6 and 12 month outcomes from a randomized trial.

BACKGROUND: Smoking cessation often results in weight gain which discourages many smokers from quitting and can increase health risks. Treatments to reduce cessation-related weight gain have been tested in highly controlled trials of in-person treatment, but have never been tested in a real-world setting, which has inhibited dissemination. METHODS: The Best Quit Study (BQS) is a replication and "real world" translation using telephone delivery of a prior in-person efficacy trial. DESIGN: randomized control trial in a quitline setting. Eligible smokers (n = 2540) were randomized to the standard 5-call quitline intervention or quitline plus simultaneous or sequential weight management. Regression analyses tested effectiveness of treatments on self-reported smoking abstinence and weight change at 6 and 12 months. RESULTS: Study enrollees were from 10 commercial employer groups and three state quitlines. Participants were between ages 18-72, 65.8% female, 68.2% white; 23.0% Medicaid-insured, and 76.3% overweight/obese. The follow-up response rate was lower in the simultaneous group than the control group at 6 months (p = 0.01). While a completers analysis of 30-day point prevalence abstinence detected no differences among groups at 6 or 12 months, multiply imputed abstinence showed quit rate differences at 6 months for:simultaneous (40.3%) vs. sequential (48.3%), p = 0.034 and simultaneous vs. control (44.9%), p = 0.043. At 12 months, multiply imputed abstinence, was significantly lower for the simultaneous group (40.7%) vs. control (46.0%), p < 0.05 and vs. sequential (46.3%), p < 0.05. Weight gain at 6 and 12 months was minimal and not different among treatment groups. The sequential group completed fewer total calls (3.75) vs. control (4.16) and vs. simultaneous group (3.83), p = 0.01, and fewer weight calls (0.94) than simultaneous (2.33), p < 0.0001. The number of calls completed predicted 30-day abstinence, p < 0.001, but not weight outcomes. DISCUSSION: This study offers a model for evaluating population-level public health interventions conducted in partnership with tobacco quitlines. CONCLUSIONS: Simultaneous (vs. sequential) delivery of phone/web weight management with cessation treatment in the quitline setting may adversely affect quit rate. Neither a simultaneous nor sequential approach to addressing weight produced any benefit on suppressing weight gain. This study highlights the need and the challenges of testing intensive interventions in real-world settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01867983 . Registered: May 30, 2013.

Oral Health Promotion and Smoking Cessation Program Delivered via Tobacco Quitlines: The Oral Health 4 Life Trial.

OBJECTIVES: To assess the effects of a novel oral health promotion program (Oral Health 4 Life; OH4L) delivered through state-funded tobacco quitlines. METHODS: Using a semipragmatic design to balance experimental control and generalizability, we randomized US quitline callers (n = 718) to standard care or standard care plus OH4L. We followed participants for 6 months to assess effects on professional dental care and smoking abstinence. We collected data between 2015 and 2017. RESULTS: Participants were racially diverse (42% non-White) and socioeconomically disadvantaged. Most (71%) reported fair or poor oral health, and all were overdue for routine dental care. At 6 months, professional dental care and abstinence did not significantly differ between arms, but abstinence favored the experimental arm and was significantly higher among experimental participants at 2 months in a complete case sensitivity analysis. CONCLUSIONS: OH4L was not effective for promoting dental care, but integrating oral health counseling with quitline counseling may offer some advantage for smoking cessation. Public Health Implications. We offer a model for conducting semipragmatic trials and partnering with tobacco quitlines to evaluate population-level public health interventions.

IMPLEMENTATION, RECRUITMENT AND BASELINE CHARACTERISTICS: A RANDOMIZED TRIAL OF COMBINED TREATMENTS FOR SMOKING CESSATION AND WEIGHT CONTROL.

BACKGROUND: Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. METHODS: This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management. Study participants were recruited via tobacco quitlines from August 5, 2013 to December 15, 2014. RESULTS: Statistical analysis on baseline data was conducted in 2015/2016. Among 5,082 potentially eligible callers to a tobacco quitline, 2,540 were randomized (50% of eligible). Compared with individuals eligible but not randomized, those randomized were significantly more likely to be female (65.7% vs 54.5%, p<.01), overweight or obese (76.3% vs 62.5%, p<.01), more confident in quitting (p<.01), more addicted (first cigarette within 5 minutes: 50.0% vs 44.4%, p<.01), and have a chronic disease (28.6% vs. 24.4%, p<.01). Randomized groups were not statistically significantly different on demographics, tobacco or weight variables. Two-thirds of participants were female and white with a mean age of 43. CONCLUSIONS: Adding weight management interventions to tobacco cessation quitlines was feasible and acceptable to smokers. If successful for cessation and weight outcomes, a combined intervention may provide a treatment approach for addressing weight gain with smoking cessation through tobacco quitlines.

Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial.

BACKGROUND: Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment "default." Current treatment guidelines recommend that providers (1) ask patients if they are willing to quit and (2) provide cessation-focused medications and counseling only to smokers who state that they are willing to quit. The default is that patients have to "opt in" to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say "yes." This drastically limits the reach of cessation services because, at any given encounter, only one in three smokers say that they are ready to quit. The objective of this study is to determine the impact of providing all smokers with tobacco-cessation treatment unless they refuse it (OPT OUT) versus current practice-screening for readiness and only offering treatment to smokers who say they are ready to quit (OPT IN). METHODS: This individually randomized clinical trial is conducted in a tertiary-care hospital. We will conduct the trial among up to 1000 randomly selected hospitalized smokers to determine the population impact of changing the treatment default, identify mediators of outcome, and determine the cost-effectiveness of this new, highly proactive approach. This is a population-based study that targets an endpoint of vital interest; applies minimal eligibility criteria to broaden generalizability; and utilizes hospital staff for interventions to ensure long-term sustainability. The study employs delayed consent and an innovative Bayesian adaptive design to evaluate a major shift in our approach to care. If effective, this change would expand the reach of tobacco-cessation treatment from 30% to 100% of smokers. DISCUSSION: Regardless of outcome, the trial will provide a model of how to alter and evaluate the impact of health care defaults. If OPT OUT proves to be more effective, it will expand the population eligible for cessation treatment by over 300%. It will also simplify the tobacco-cessation treatment algorithm, and relieve busy health care providers of the burden of evaluating readiness to quit. TRIAL REGISTRATION: Clinical Trials Registration, ID: NCT02721082 . Registered on 22 March 2016.

Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers.

Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve their use of oral health care. This paper details the rationale, design, and methods of a large, semi-pragmatic, randomized clinical trial designed to address this gap. Participants are recruited via the Oregon, Nebraska and Louisiana state-sponsored tobacco quitlines and randomized to receive standard quitline care versus standard care plus a multi-modal oral health promotion program (Oral Health 4 Life) integrated within the quitline services. All participants are followed for 6months to assess the impact of the intervention on smoking abstinence and utilization of professional dental care. In addition, the study will assess the cost of the intervention and provide practical guidance to states on whether the intervention is financially feasible to implement, should the intervention be effective. This study protocol may be useful to others interested in promoting oral health among smokers, those interested in partnering with tobacco quitlines to extend standard services to address other high risk health behaviors among smokers, or those interested in semi-pragmatic trial design.

Warm Handoff Versus Fax Referral for Linking Hospitalized Smokers to Quitlines.

INTRODUCTION: Few hospitals treat patients' tobacco dependence. To be effective, hospital-initiated cessation interventions must provide at least 1 month of supportive contact post-discharge. STUDY DESIGN: Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014-June 2015. SETTING/PARTICIPANTS: The study was conducted in two large Midwestern hospitals. Participants included smokers who were aged ≥18 years, planned to stay quit after discharge, and spoke English or Spanish. INTERVENTION: Hospital-based cessation counselors delivered the intervention. For patients randomized to warm handoff, staff immediately called the quitline from the bedside and handed the phone to participants for enrollment and counseling. Participants randomized to fax were referred on the day of hospital discharge. MAIN OUTCOME MEASURES: Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness. RESULTS: Significantly more warm handoff than fax participants enrolled in quitline (99.6% vs 59.6%; relative risk, 1.67; 95% CI=1.65, 1.68). One in four (25.4% warm handoff, 25.3% fax) were verified to be abstinent at 6-month follow-up; this did not differ significantly between groups (relative risk, 1.02; 95% CI=0.82, 1.24). Cessation medication use in the hospital and receipt of a prescription for medication at discharge did not differ between groups; however, significantly more fax participants reported using cessation medication post-discharge (32% vs 25%, p=0.01). The average incremental cost-effectiveness ratio of enrolling participants into warm handoff was $0.14. Hospital-borne costs were significantly lower in warm handoff than in fax ($5.77 vs $9.41, p<0.001). CONCLUSIONS: One in four inpatient smokers referred to quitline by either method were abstinent at 6 months post-discharge. Among motivated smokers, fax referral and warm handoff are efficient and comparatively effective ways to link smokers with evidence-based care. For hospitals, warm handoff is a less expensive and more effective method for enrolling smokers in quitline services.

The effect of tobacco cessation on weight gain, obesity, and diabetes risk.

OBJECTIVE: Most smokers gain weight after quitting, and some develop new onset obesity and type 2 diabetes. The purpose of this paper is to synthesize the current science investigating the consequences of tobacco cessation on body weight and diabetes, as well as intervention strategies that minimize or prevent weight gain while still allowing for successful tobacco cessation. METHODS: Systematic reviews and relevant studies that were published since prior reviews were selected. RESULTS: Smoking cessation can cause excessive weight gain in some individuals and can be associated with clinically significant outcomes such as diabetes or obesity onset. Interventions that combine smoking cessation and weight control can be effective for improving cessation and minimizing weight gain but need to be tested in specific populations. CONCLUSIONS: Despite the health benefits of quitting tobacco, post-cessation weight gain and new onset obesity and diabetes are a significant concern. Promising interventions may need to be more widely applied to reduce the consequences of both obesity and tobacco use.

Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial.

BACKGROUND: Prevalence of multiple health risk behaviors is growing, and obesity and smoking are costly. Weight gain associated with quitting smoking is common and can interfere with quit success. Efficacy of adding weight management to tobacco cessation treatment has been tested with women in group sessions over an extended period of time, but has never been tested in real-world settings with men and women seeking help to quit. This paper describes the Best Quit study which tests the effectiveness of delivering tobacco and weight control interventions via existing quitline infrastructures. METHODS: Eligible and consenting smokers (n = 2550) who call a telephone quitline will be randomized to one of three groups; the standard quitline or standard quitline plus a weight management program added either simultaneously or sequentially to the tobacco program. The study aims to test: 1) the effectiveness of the combined intervention on smoking cessation and weight, 2) the cost-effectiveness of the combined intervention on cessation and weight and 3) theoretically pre-specified mediators of treatment effects on cessation: reduced weight concerns, increased outcome expectancies about quitting and improved self-efficacy about quitting without weight gain. Baseline, 6 month and 12 month data will be analyzed using multivariate statistical analyses and groups will be compared on treatment adherence, quit rates and change in weight among abstinent participants. To determine if the association between group assignment and primary outcomes (30-day abstinence and change in weight at 6 months) is moderated by pre-determined baseline and process measures, interaction terms will be included in the regression models and their significance assessed. DISCUSSION: This study will generate information to inform whether adding weight management to a tobacco cessation intervention delivered by phone, mail and web for smokers seeking help to quit will help or harm quit rates and whether a simultaneous or sequential approach is better at increasing abstinence and reducing weight gain post quit. If proven effective, the combined intervention could be disseminated across the U.S. through quitlines and could encourage additional smokers who have not sought cessation treatment for fear of gaining weight to make quit attempts. TRIAL REGISTRATION: Clinicaltrials.gov NCT01867983 . Registered: May 30, 2013.

Knowledge and beliefs about electronic cigarettes among quitline cessation staff.

INTRODUCTION: Smokers are asking health practitioners for guidance about using e-cigarettes as an aid to quitting. Several studies have surveyed physicians. However, in North America many smokers seek help from telephone quitlines rather than physicians. The objective of the current study was to assess quitline counselors' perceptions of e-cigarettes and what they tell callers about these products. METHODS: An online cross-sectional survey, conducted in 2014 with 418 quitline counselors in the U.S. and Canada, measured perceptions of e-cigarettes: (1) use as a quitting aid; (2) safety; (3) professional guidance given and organizational guidance received; (4) regulation. The response rate was 90.1%. Analyses included calculating standard errors and 95% confidence intervals around summary statistics. RESULTS: Nearly 70% of counselors believed that e-cigarettes are not effective quitting aids. Most believed e-cigarettes are addictive (87%) and that secondhand exposure to vapor is harmful (71%). Counselors reported that callers ask for advice about e-cigarettes, but few counselors recommended e-cigarettes (4%). Counselors (97%) reported being instructed by quitline employers to explain to clients that e-cigarettes are not FDA-approved; 74% were told to recommend approved quitting aids instead. Most counselors (>87%) believed e-cigarettes should be regulated like cigarettes in terms of advertising, taxation, access by minors, and use in public places. CONCLUSIONS: Quitline counselors view e-cigarettes as ineffective quitting aids, potentially dangerous, and in need of greater regulations. Counselors can influence how treatment seekers view e-cigarettes, therefore it is imperative that quitlines stay abreast of emerging data and communicate about these products in ways that best serve clients.

Post-cessation weight concerns among women calling a state tobacco quitline.

BACKGROUND: Obese and overweight women who smoke are more likely to be concerned about weight gain following cessation, impacting ability to quit and relapse. PURPOSE: To determine differences in weight concerns for underweight, normal weight, overweight, and obese female smokers by race/ethnicity. METHODS: From March to November 2008, female adult tobacco users calling the Oklahoma Tobacco Helpline were asked questions to determine the prevalence of obesity and concern for cessation-related weight gain. A score of 50 or greater, where 0=not at all concerned and 100=very concerned, on one of two weight concerns questions defined the outcome. BMI was calculated from self-reported height and weight. For the current analyses in 2013, race, ethnicity, age, education, marital status, and tobacco use history were examined as covariates. Multiple logistic regression was used to calculate ORs and 95% CIs. RESULTS: A significant interaction between race and BMI was observed; thus, separate models were created for white (n=3,579); black (n=330); American Indian (n=441); and Hispanic (n=125) women. BMI was independently associated with weight concerns among all racial/ethnic groups, but the strength of the association varied. For black and Hispanic women, there was a particularly strong association between BMI and weight concerns among obese women (OR=9.55, 95% CI=5.05, 18.07, and OR=8.46, 95% CI=2.57, 27.83, respectively), although sample sizes were small. CONCLUSIONS: State quitlines should consider tailoring promotional efforts and treatment protocols to include concerns about weight gain, especially for obese African American and Hispanic smokers.