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.

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.

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.

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.

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.

Helpers program: A pilot test of brief tobacco intervention training in three corporations.

BACKGROUND: Quitlines and worksite-sponsored cessation programs are effective and highly accessible, but limited by low utilization. Efforts to encourage use of cessation aids have focused almost exclusively on the smoker, overlooking the potential for friends, family, co-workers, and others in a tobacco user's social network to influence quitting and use of effective treatment. METHODS: Longitudinal, observational pilot feasibility study with 6-week follow-up survey. SETTING/PARTICIPANTS: Employees of three national corporations, with a combined target audience of 102,100 employees. INTERVENTION: The Helpers Program offers web-based, brief intervention training to activate social networks of tobacco users to encourage quitting and use of effective treatment. Helpers was offered from January 10 to March 31, 2008, as a treatment engagement strategy, together with Free & Clear's telephone/web-based cessation services. MAIN OUTCOME MEASURES: Website utilization, training completion, post-training changes in knowledge and self-efficacy with delivery of brief interventions, referrals to Free & Clear, and use of brief intervention training. RESULTS: There were 19,109 unique visitors to the Helpers website. Of these, 4727 created user accounts; 1427 registered for Helpers Training; 766 completed training. There were 445 visits to the referral page and 201 e-mail or letter referrals generated. There were 67 requests for technical support. Of follow-up survey respondents (n=289), 78.9% reported offering a brief intervention. CONCLUSIONS: Offering the Helpers Program website to a large, diverse audience as part of an employer-sponsored worksite health promotion program is both feasible and well accepted by employees. Website users will participate in training, encourage quitting, and refer smokers to quitline services.

Address the gaps in tobacco cessation training and services: developing professional organisational alliances to create social movements.

ISSUES: To contribute towards reversing the tobacco pandemic, professional organisational alliances must reduce the wide international variability in the smoking rates among health-care professionals and students, and also address the gaps in tobacco cessation training and services. APPROACH: Ongoing international surveys for monitoring smoking rates could provide the impetus for these alliances to develop programs that reduce smoking rates among professional and lay populations. KEY FINDINGS: Health professional organisations must advocate for systematically implementing comprehensive tobacco cessation training programs. IMPLICATIONS: These programs can include both evidence-based interventions and experience-based learning innovations. These innovations can help individuals address the limitations of evidence-based guidelines. This shift from teaching individuals about changing-specific risk behaviours to engaging individuals to learn how to change any risk behaviour expands the reach and impact of behaviour change programs. CONCLUSIONS: Practitioners and staff need first-hand experience of these learning innovations before guiding patients through the same process. Using both evidence-based guidelines and experience-based learning methods, organisational leaders can develop professional alliances to create social movements that promote healthy habits in general. For example, they can develop voluntary learning programs in primary care and community settings that are led by patients and that are for patients. Such bottom-up approaches have greater potential yield in addressing gaps in health promotion and disease prevention, and particularly for tobacco cessation services. This strategy is a more feasible option for resource-limited, developing countries that cannot afford costly tobacco cessation programs.