Weight management in rural health clinics: Results from the randomized midwest diet and exercise trial.

Introduction: Rural living adults have higher rates of obesity compared with their urban counterparts and less access to weight management programs. Previous research studies have demonstrated clinically relevant weight loss in rural living adults who complete weight management programs delivered by university affiliated interventionists. However, this approach limits the potential reach, adoption, implementation, and maintenance of weight management programs for rural residents. Weight management delivered through rural health clinics by non-physician clinic associated staff, for example, nurses, registered dieticians, allied health professionals, etc. has the potential to improve access to weight management for rural living adults. This trial compared the effectiveness of a 6-month multicomponent weight management intervention for rural living adults delivered using group phone calls (GP), individual phone calls (IP) or an enhanced usual care control (EUC) by rural clinic associated staff trained by our research team. Methods: Rural living adults with overweight/obesity (n = 187, age âˆ¼ 50 years 82% female, body mass index ∼35 kg/m2) were randomized (2:2:1) to 1 of 3 intervention arms: GP, which included weekly âˆ¼ 45 min sessions with 7-14 participants (n = 71), IP, which included weekly âˆ¼ 15 min individual sessions (n = 80), or EUC, which included one-45 min in-person session at baseline. Results: Weight loss at 6 months was clinically relevant, that is, ≥5% in the GP (-11.4 kg, 11.7%) and the IP arms (-9.1 kg, 9.2%) but not in the EUC arm (-2.6%, -2.5% kg). Specifically, 6 month weight loss was significantly greater in the IP versus EUC arms (-6.5 kg. p ≤ 0.025) but did not differ between the GP and IP arms (-2.4 kg, p > 0.025). The per participant cost per kg. weight loss for implementing the intervention was $93 and $60 for the IP and GP arms, respectively. Conclusions: Weight management delivered by interventionists associated with rural health clinics using both group and IP calls results in clinically relevant 6 months weight loss in rural dwelling adults with overweight/obesity with the group format offering the most cost-effective strategy. Clinical trial registration: ClinicalTrials.gov (NCT02932748).

Menthol versus tobacco e-liquid flavor: Impact on acute subjective effects, puff patterns, and intentions for use among Black and White menthol smokers.

BACKGROUND: The proposed FDA product standard to prohibit menthol as a characterizing flavor in combustible cigarettes has the potential to significantly reduce tobacco-related health disparities. Whether a menthol e-liquid product standard would improve or hinder public health is unknown. No known research has directly examined the impact of menthol vs. tobacco flavored e-liquid use on acute e-cigarette use patterns, subjective experience, behavioral intentions, and craving and withdrawal among menthol cigarette smokers. METHODS: Black (n = 47) and White (n = 4) nicotine-deprived menthol smokers with limited e-cigarette experience completed two counterbalanced in-laboratory 30-minute ad libitum vaping sessions with menthol and tobacco nicotine salt-based e-liquid in a randomized crossover pilot trial design. Questionnaires assessed reductions in craving and withdrawal and post-session subjective experience and behavioral intentions. Puff topography was measured continuously throughout each vaping session. RESULTS: Measures of puff topography did not differ significantly by e-liquid flavor (all p > .40). Similarly, menthol and tobacco flavored e-cigarettes were both rated positively in terms of subjective effects and behavioral intentions (all p > .10) and about 40 % of participants reported a preference for the tobacco-flavored e-liquid. Finally, participants showed comparable reductions in craving (p = .210) and withdrawal (p = .671) from pre- and post-session regardless of e-liquid flavor. CONCLUSIONS: Among menthol smokers in a lab-based setting, findings suggest that menthol vs tobacco e-liquid flavor has little impact on acute changes in puff patterns, subjective experience, behavioral intentions, or craving and withdrawal.

Using Bayesian hierarchical modeling for performance evaluation of clinical trial accrual for a cancer center.

Introduction: Slow patient accrual in cancer clinical trials is always a concern. In 2021, the University of Kansas Comprehensive Cancer Center (KUCC), an NCI-designated comprehensive cancer center, implemented the Curated Cancer Clinical Outcomes Database (C3OD) to perform trial feasibility analyses using real-time electronic medical record data. In this study, we proposed a Bayesian hierarchical model to evaluate annual cancer clinical trial accrual performance. Methods: The Bayesian hierarchical model uses Poisson models to describe the accrual performance of individual cancer clinical trials and a hierarchical component to describe the variation in performance across studies. Additionally, this model evaluates the impacts of the C3OD and the COVID-19 pandemic using posterior probabilities across evaluation years. The performance metric is the ratio of the observed accrual rate to the target accrual rate. Results: Posterior medians of the annual accrual performance at the KUCC from 2018 to 2023 are 0.233, 0.246, 0.197, 0.150, 0.254, and 0.340. The COVID-19 pandemic partly explains the drop in performance in 2020 and 2021. The posterior probability that annual accrual performance is better with C3OD in 2023 than pre-pandemic (2019) is 0.935. Conclusions: This study comprehensively evaluates the annual performance of clinical trial accrual at the KUCC, revealing a negative impact of COVID-19 and an ongoing positive impact of C3OD implementation. Two sensitivity analyses further validate the robustness of our model. Evaluating annual accrual performance across clinical trials is essential for a cancer center. The performance evaluation tools described in this paper are highly recommended for monitoring clinical trial accrual.

The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial.

INTRODUCTION: People who smoke cigarettes are more likely than people who do not to use cannabis, including blunts, a tobacco product containing nicotine and marijuana. Blunts represent a challenge for cessation trials because nicotine could make stopping cigarettes more difficult. Few studies have examined the impact of blunt use on individuals actively engaged in a cigarette quit attempt. METHODS: Blunt use was assessed at baseline, Weeks 4, 8, 12, 16, and 26 among Black adult people who smoke enrolled in a double-blind, placebo-controlled, randomized trial of varenicline (VAR, n = 300) versus placebo (PBO, n = 200) for smoking cessation. Participants were categorized as ever blunt (blunt use reported at any timepoint) versus non-blunt (no blunt use reported). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at Weeks 12 and 26. Logistic regression examined the effects of treatment and blunt use on abstinence. RESULTS: 75 participants (mean age 45.6 years (SD = 12.5, range: 22,80); 32 (42%) female) reported blunt use. Logistic regression analyses showed no treatment by blunt use interaction or significant main effect of blunt use on smoking abstinence at Weeks 12 or 26 (p > 0.05). After adjusting for treatment, those who used blunts had statistically similar odds of quitting at Week 12 (OR: 0.68, 95% CI: 0.31, 1.5) and Week 26 (OR: 0.84, 95% CI: 0.38, 1.87) as those who never used blunts during the study. DISCUSSION: Blunt use had no statistically significant impact on cessation among participants in a smoking cessation clinical trial. Future trials are needed in which the target of cessation is all combustible products.

Conducting a bayesian multi-armed trial with response adaptive randomization for comparative effectiveness of medications for CSPN.

Background: Response adaptive randomization is popular in adaptive trial designs, but the literature detailing its execution is lacking. These designs are desirable for patients/stakeholders, particularly in comparative effectiveness research, due to the potential benefits including improving participant buy-in by providing more participants with better treatment during the trial. Frequentist approaches have often been used, but adaptive designs naturally fit the Bayesian methodology; it was developed to deal with data as they come in by updating prior information. Methods: PAIN-CONTRoLS was a comparative-effectiveness trial utilizing Bayesian response adaptive randomization to four drugs, nortriptyline, duloxetine, pregabalin, or mexiline, for cryptogenic sensory polyneuropathy (CSPN) patients. The aim was to determine which treatment was most tolerable and effective in reducing pain. Quit and efficacy rates were combined into a utility function to develop a single outcome, which with treatment sample size, drove the adaptive randomization. Prespecified interim analyses allowed the study to stop for early success or update the randomization probabilities to the better-performing treatments. Results: Seven adaptations to the randomization occurred before the trial ended due to reaching the maximum sample size, with more participants receiving nortriptyline and duloxetine. At the end of the follow-up, nortriptyline and duloxetine had lower probabilities of participants that had stopped taking the study medication and higher probabilities were efficacious. Mexiletine had the highest quit rate, but had an efficacy rate higher than pregabalin. Conclusions: Response adaptive randomization has become a popular trial tool, especially for those utilizing Bayesian methods for analyses. By illustrating the execution of a Bayesian adaptive design, using the PAIN-CONTRoLS trial data, this paper continues the work to provide literature for conducting Bayesian response adaptive randomized trials.

Early Treatment Response in Black Smokers Undergoing Pharmacotherapy for Smoking Cessation: A Secondary Analysis of a Randomized Clinical Trial.

This secondary analysis of a randomized clinical trial investigates the association of early treatment response with smoking cessation among Black smokers.

Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke: A Randomized Clinical Trial.

Importance: Adapting to different smoking cessation medications when an individual has not stopped smoking has shown promise, but efficacy has not been tested in racial and ethnic minority individuals who smoke and tend to have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Objective: To evaluate efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily. Design, Setting, and Participants: This randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC) included non-Hispanic Black adults who smoke and was conducted from May 2019 to January 2022 at a federally qualified health center in Kansas City, Missouri. Data analysis took place from March 2022 to January 2023. Interventions: Both groups received 18 weeks of pharmacotherapy with long-term follow-up through week 26. The ADT group consisted of 196 individuals who received a nicotine patch (NP) and up to 2 pharmacotherapy adaptations, with a first switch to varenicline at week 2 and, if needed, a second switch to bupropion plus NP (bupropion + NP) based on carbon monoxide (CO)-verified smoking status (CO ≥6 ppm) at week 6. The UC group consisted of 196 individuals who received NP throughout the duration of treatment. Main Outcomes and Measures: Anabasine-verified and anatabine-verified point-prevalence abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points). The χ2 test was used to compare verified abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points) between ADT and UC. A post hoc sensitivity analysis of smoking abstinence at week 12 was performed with multiple imputation using a monotone logistic regression with treatment and gender as covariates to impute the missing data. Results: Among 392 participants who were enrolled (mean [SD] age, 53 [11.6] years; 224 [57%] female; 186 [47%] ≤ 100% federal poverty level; mean [SD] 13 [12.4] cigarettes per day), 324 (83%) completed the trial. Overall, 196 individuals were randomized to each study group. Using intent-to-treat and imputing missing data as participants who smoke, verified 7-day abstinence was not significantly different by treatment group at 12 weeks (ADT: 34 of 196 [17.4%]; UC: 23 of 196 [11.7%]; odds ratio [OR], 1.58; 95% CI, 0.89-2.80; P = .12), 18 weeks (ADT: 32 of 196 [16.3%]; UC: 31 of 196 [15.8%]; OR, 1.04; 95% CI, 0.61-1.78; P = .89), and 26 weeks (ADT: 24 of 196 [12.2%]; UC: 26 of 196 [13.3%]; OR, 0.91; 95% CI, 0.50-1.65; P = .76). Of the ADT participants who received pharmacotherapy adaptations (135/188 [71.8%]), 11 of 135 (8.1%) were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had CO-verified abstinence at week 2 had 4.6 times greater odds of being abstinent at week 12 (37 of 129 [28.7%] abstinence) than those who did not respond to treatment (19 of 245 [7.8%] abstinence; OR; 4.6; 95% CI, 2.5-8.6; P < .001). Conclusions and Relevance: In this randomized clinical trial of adapted vs standard of care pharmacotherapy, adaptation to varenicline and/or bupropion + NP after failure of NP monotherapy did not significantly improve abstinence rates for Black adults who smoke relative to those who continued treatment with NP. Those who achieved abstinence in the first 2 weeks of the study were significantly more likely to achieve later abstinence, highlighting early treatment response as an important area for preemptive intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03897439.

Concurrent Choice Assessment of Preference and Substitutability of E-cigarettes and Heated Tobacco Products for Combustible Cigarettes Among African American and White Smokers.

INTRODUCTION: Alternative nicotine delivery products, including electronic cigarettes (e-cigarettes) and heated tobacco products (HTPs), contain fewer toxicants than combustible cigarettes and offer a potential for harm reduction. Research on the substitutability of e-cigarettes and HTPs is crucial for understanding their impact on public health. This study examined subjective and behavioral preferences for an e-cigarette and HTP relative to participants' usual brand combustible cigarette (UBC) in African American and White smokers naïve to alternative products. AIMS AND METHODS: Twenty-two adult African American (n = 12) and White (n = 10) smokers completed randomized study sessions with their UBC and study provided e-cigarette and HTP. A concurrent choice task allowed participants to earn puffs of the products but placed UBC on a progressive ratio schedule, making puffs harder to earn, and e-cigarette and HTP on a fixed ratio schedule to assess behavioral preference for the products. Behavioral preference was then compared to self-reported subjective preference. RESULTS: Most participants had a subjective preference for UBC (n = 11, 52.4%), followed by an equal preference for e-cigarette (n = 5, 23.8%) and HTP (n = 5, 23.8%). During the concurrent choice task, participants showed a behavioral preference (i.e., more earned puffs) for the e-cigarette (n = 9, 42.9%), followed by HTP (n = 8, 38.1%), and UBC (n = 4, 19.1%). Participants earned significantly more puffs of the alternative products compared to UBC (p = .011) with no difference in earned puffs between e-cigarettes and HTP (p = .806). CONCLUSIONS: In a simulated lab setting, African American and White smokers were willing to substitute UBC for an e-cigarette or HTP when the attainment of UBC became more difficult. TRIAL REGISTRATION: NCT04646668. IMPLICATIONS: Findings suggest that African American and White smokers are willing to substitute their UBC for an alternative nicotine delivery product (e-cigarette or HTP) when the attainment of cigarettes became more difficult in a simulated lab setting. Findings require confirmation among a larger sample under real-world conditions but add to growing evidence suggesting the acceptability of alternative nicotine delivery products among racially diverse smokers. These data are important as policies that limit the availability or appeal of combustible cigarettes are considered or enacted.

Menthol versus non-menthol flavouring and switching to e-cigarettes in black and Latinx adult menthol combustible cigarette smokers: secondary analyses from a randomised clinical trial.

BACKGROUND: As the US Food and Drug Administration takes regulatory action on menthol cigarettes, debate continues about how restricting menthol e-liquids might impact adult menthol smokers in switching to e-cigarettes. METHODS: Switching patterns and e-cigarette acceptability were assessed at week 6 among 64 black and Latinx menthol cigarette smokers who used JUUL menthol (n=39) or non-menthol e-cigarettes ((n=25), primarily mint or mango) as part of a randomised switching trial. RESULTS: No clear evidence of effects was found between menthol versus non-menthol e-cigarettes on use or subjective effects/acceptability, effect sizes for all comparisons were small (effect size=0.0-0.2), and Bayes factor ranged from 0.10 to 0.15. Specifically, 82.1% of participants who used menthol-flavoured e-cigarettes fully or partially switched to e-cigarettes compared with 88.0% of participants who used a non-menthol (p=0.75). Further, both groups demonstrated substantial reductions in cigarettes per day (menthol e-cigarettes: -8.5±10.4 vs non-menthol e-cigarettes: -8.8±5.8, p=0.87), comparable grams of e-liquid consumed (menthol e-cigarettes: 9.2±9.8 g vs non-menthol e-cigarettes: 11.0±11.0 g, p=0.47), and positive subjective effects, including 'just right' throat hit (menthol e-cigarettes: 70.7% vs non-menthol e-cigarettes: 66.7%, p=0.93) and flavour liking (menthol e-cigarettes: 75.6% vs non-menthol e-cigarettes: 66.7%, p=0.32). CONCLUSIONS: Both menthol and non-menthol e-cigarettes were associated with high rates of use and acceptability among menthol smokers. Findings require confirmation in a fully powered non-inferiority or equivalence study but provide preliminary evidence to inform regulatory action on menthol e-cigarettes that could slow youth initiation without impacting black and Latinx menthol cigarette smokers interested in switching to e-cigarettes. TRIAL REGISTRATION NUMBER: NCT03511001.

A randomized trial comparing diet and delivery strategies for weight management in adolescents with intellectual disabilities.

BACKGROUND: The literature evaluating multi-component interventions for long-term weight loss in adolescents with intellectual disabilities (ID) is extremely limited. OBJECTIVES: To compare the effectiveness of two delivery strategies, face-to-face (FTF) or remote delivery (RD), and two diets, enhanced Stop Light diet (eSLD) or conventional diet (CD) on weight change across 12 and 18 months. in response to an 18 months. weight management intervention (6 months Weight loss/12 months. Weight maintenance) in adolescents with ID. METHODS: Adolescents with ID were randomized to one of three arms: FTF /CD, RD/CD, RD/eSLD and asked to attend individual education sessions with a health educator which were delivered during FTF home visits or remotely using video conferencing. The CD followed the US dietary guidelines. The eSLD utilized the Stop Light guide and was enhanced with portion-controlled meals. Participants were also asked to increase their physical activity (PA) and to self-monitor diet, PA and body weight across the 18-month. RESULTS: Weight was obtained from 92(84%) and 89(81%) randomized adolescents at 12 and 18 months, respectively. Weight change across 12 months. Differed significantly by diet (RD/eSLD: -7.0% vs. RD/CD: -1.1%, p = 0.002) but not by delivery strategy (FTF/CD: +1.1% vs. RD/CD: -1.1%, p = 0.21). Weight change across 18 months. Was minimal in all intervention arms and did not differ by diet (RD/eSLD: -2.6% vs. RD/CD: -0.5%; p = 0.28) or delivery strategy (FTF/CD: +1.6% vs. RD/CD: -0.5%; p = 0.47). CONCLUSIONS: Additional research is required to identify effective strategies to improve long-term weight loss in adolescents with ID.

Bolstering the complex study start-up process at NCI cancer centers using technology.

Background: The study startup process for interventional clinical trials is a complex process that involves the efforts of many different teams. Each team is responsible for their startup checklist in which they verify that the necessary tasks are done before a study can move on to the next team. This regulatory process provides quality assurance and is vital for ensuring patient safety [10]. However, without having this startup process centralized and optimized, study approval can take longer than necessary as time is lost when it passes through many different hands. Objective: This manuscript highlights the process and the systems that were developed at The University of Kansas Comprehensive Cancer Center regarding the study startup process. To facilitate this process the regulatory management, site development, cancer center administration, and the Biostatistics & Informatics Shared Resources (BISR) teams came together to build a platform aimed at streamlining the startup process and providing a transparent view of where a study is in the startup process. Process: Ensuring the guidelines are clearly articulated for the review criteria of each of the three review boards, i.e., Disease Working Group (DWG), Executive Resourcing Committee (ERC), and Protocol Review and Monitoring Committee (PRMC) along with a system that can track every step and its history throughout the review process. Results: Well-defined processes and tracking methodologies have allowed the operations teams to track each study closely and ensure the 90-day and 120-day deadlines are met, this allows the operational team to dynamically prioritize their work daily. It also provides Principal investigators a transparent view of where their study stands within the study startup process and allows them to prepare for the next steps accordingly. Conclusion/future work: The current process and technology deployment has been a significant improvement to expedite the review process and minimize study startup delays. There are still a few opportunities to fine-tune the study startup process; an example of which includes automatically informing the operational managers or the study teams to act upon deadlines regarding study review rather than the current manual communication process which involves them looking it up in the system which can add delays.

Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke.

Background: The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Methods: The current study is comparing the efficacy of optimized (OPT) versus enhanced usual care (UC) for smoking cessation in African Americans (AA) who smoke cigarettes. AAs who smoke (n = 392) are randomized 1:1 to OPT or UC. Participants in both groups receive 7 sessions of smoking cessation counseling and18-weeks of pharmacotherapy with long-term follow-up through Week 26. OPT participants receive nicotine patch and up to two pharmacotherapy adaptations to varenicline and bupropion plus patch based on carbon monoxide verified smoking status (≥6 ppm) at Weeks 2 and 6. UC participants receive patch throughout the duration of treatment. We hypothesize that OPT will be more effective than UC on the primary outcome of biochemically verified abstinence at Week 12. Discussion: If effective, findings could broaden the scope of tobacco dependence treatment and move the field toward optimization strategies that impro ve abstinence for AA who smoke. Trial registration: NCT03897439.

Rural-Urban Disparities in Health Access Factors Over Time: Implications for Cancer Prevention and Health Equity in the Midwest.

Purpose: Population-level environmental and socioeconomic factors may influence cancer burden within communities, particularly in rural and urban areas that may be differentially impacted by factors related to health care access. Methods: The University of Kansas (KU) Cancer Center serves a geographically large diverse region with 75% of its 123 counties classified as rural. Using County Health Rankings data and joinpoint regression, we examined trends in four factors related to the socioeconomic environment and health care access from 2009 to 2017 in rural and urban counties across the KU Cancer Center catchment area. Findings: The adult health uninsurance rate declined significantly in rural and urban counties across the catchment area (rural annual percent change [APC]=-5.96; 95% CI=[-7.71 to -4.17]; urban APC=-5.72; 95% CI=[-8.03 to -3.35]). Childhood poverty significantly decreased in rural counties over time (APC=-2.94; 95% CI=[-4.52 to -1.33]); in contrast, urban childhood poverty rates did not significantly change before 2012 (APC=3.68; 95% CI=[-15.12 to 26.65]), after which rates declined (APC=-5.89; 95% CI=[-10.01 to -1.58]). The number of primary care providers increased slightly but significantly in both rural and urban counties (APC=0.54; 95% CI=[0.28 to 0.80]), although urban counties had more primary care providers than rural areas (76.1 per 100K population vs. 57.1 per 100K population, respectively; p=0.009). Unemployment declined significantly faster in urban counties (APC=-10.33; 95% CI=[-12.16 to -8.47]) compared with rural counties (APC=-6.71; 95% CI=[-8.22 to -5.18]) (p=0.02). Conclusion: Our findings reveal potential disparities in systemic factors that may contribute to differences in cancer prevention, care, and survivorship in rural and urban regions.

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.

Importance: African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels. Objectives: To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers. Design, Setting, and Participants: The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018. Interventions: Participants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]). Main Outcomes and Measures: The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d). Results: Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]). Conclusions and Relevance: Among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers. Trial Registration: ClinicalTrials.gov Identifier: NCT02360631.

The impact of COVID-19 on income and employment and willingness to become vaccinated among African Americans enrolled in a smoking cessation randomized trial.

Given vulnerability to COVID-19 among smokers and vaccine hesitancy among populations disproportionately burdened with COVID-19, it's important to understand concerns about vaccines and the impact of COVID-19 on these subgroups. Among our all African American (AA) sample of smokers (N = 172) enrolled in alargersmoking cessation clinical trial, results demonstrated an intensive burden from COVID-19; 42 (24.4%) lost employment, 56 (32.6%) lost household income, and 66 (38.4%) reportedinability to pay bills and buy food due to COVID. Most, 103 (64.4%), were willing to get vaccinated. Among the vaccine-hesitant, 57 (35.6%), concerns about COVID-19 vaccine development and mistrust in vaccines were primary reasons for unwillingness to get vaccinated. Few identified doctor's advice as most valued in deciding if the vaccine was the best option. Findings highlight high openness to the vaccine among smokers impacted by COVID but reiterate the need for community-engaged versus health system-driven approaches to improve vaccine hesitancy among racial/ethnic minorities.

Accelerating Cancer Patient Recruitment Through a Mobile Application (Clinical Trial Finder).

OBJECTIVE: Participant recruitment is a challenge for any clinical trial but is especially complex in cancer specifically due to the need to initiate treatment urgently. Most participants enrolled in oncology clinical trials are identified as potential participants by the oncologist or other referring provider. Optimal clinical care for patients with cancer includes consideration of participation in a clinical trial. However, the process of finding a clinical trial that is appropriate the patient can be cumbersome and time consuming. MATERIAL AND METHODS: The University of Kansas Cancer Center has developed a mobile application (app) which streamlines the clinical trial search process for physicians, patients, and caregivers by cohesively integrating all clinical trials currently recruiting in the center and making them easy to browse. RESULTS: Key aspects of the app include simple filtering options, the ability to search for trials by name, easily accessible assistance, and in-app referral by phone or email. Initial feedback on the app has been very positive, with several suggestions already being implemented in future development. The app was designed to be used both by physicians to find trials, as well as patients in collaboration with their physicians. CONCLUSION: While long-term results will be crucial to understanding how the app can best serve our patient population, our initial results suggest that health system specific clinical trial apps can address a currently unmet need in the clinical trial recruitment process.

Changes in dependence, withdrawal, and craving among adult smokers who switch to nicotine salt pod-based e-cigarettes.

BACKGROUND AND AIMS: For electronic cigarettes (e-cigarettes) to be a viable substitute for combustible cigarettes, it is likely that they must be rewarding enough for regular use, indicated by factors such as craving and dependence, important aspects of reinforcement. This study aimed to understand short-term changes in measures of nicotine dependence between groups differing by use trajectory in a switching trial, and within group changes of these measures. DESIGN: Secondary data analysis of one arm of an e-cigarette randomized clinical trial. SETTING: San Diego, California and Kansas City, Missouri, United States. PARTICIPANTS: 114 African American (n = 60) and Latinx (n = 54) smokers (58.8% male) attempting to switch to nicotine salt pod system (NSPS) e-cigarettes in a 6-week trial. MEASUREMENTS: At week 6, participants were classified by use trajectory: exclusive smokers (n = 16), exclusive e-cigarette (n = 32), or dual users (n = 66). E-cigarette, cigarette, and total nicotine dependence (cigarette + e-cigarette), use patterns, cigarette craving and nicotine withdrawal, and cotinine were assessed at baseline and week 6 using standard measures. FINDINGS: In between group comparisons, exclusive e-cigarette and dual users showed greater reductions in cigarette dependence (e-cigarette: -32.38, 95% CI = -37.7,-27.1; dual: -18.48, 95% CI = -22.2,-14.7), withdrawal (e-cigarette: -6.25, 95% CI = -8.52,-3.98; dual: -3.18, 95% CI = -5.02,-1.34), craving (e-cigarette: -11.44, 95% CI = -14.2,8.7; dual: -9.59, 95% CI = -11.6,-7.59), and cigarettes per day (CPD; e-cigarette: -11.19, 95% CI = -13.1,-9.27; dual: -9.39, 95% CI = -11.3, -7.52) compared with exclusive smokers. In within group analyses, e-cigarette and dual users showed reductions in craving and withdrawal from baseline to week 6. Exclusive e-cigarette and dual users, maintained cotinine levels (all Ps > 0.05) and showed reductions in CPD and cigarette dependence (all Ps < 0.01). Findings were inconclusive regarding changes in total nicotine dependence from baseline to week 6 among exclusive e-cigarette users (P = 0.123). Dual users showed increased total nicotine dependence (P < 0.001) and smokers showed decreased total dependence (P = 0.004). CONCLUSIONS: Smokers who switch to nicotine salt pod system e-cigarettes maintain their nicotine levels and transfer their dependence, suggesting that nicotine salt pod system e-cigarettes have a similar reinforcement potential to cigarettes and facilitate switching.

The effect of area-level disadvantage and race on smoking abstinence in a clinical trial.

Reasons for Black-White disparities in smoking abstinence are not well understood. This study examined area-level socioeconomic disadvantage as a contributor to lower quit rates for Blacks who smoke among 223 Black and 221 White low-income individuals who smoke enrolled in a smoking cessation trial. Outcome was cotinine-verified abstinence at week 26. Census tract-level disadvantage was measured using 5-year estimates linked to participants' home address and included percentage of: female headed households; public assistance; unemployed; < 100% of the federal poverty level; and whether there was > 25% having less than a high school education. A neighborhood disadvantage index score (DIS) was calculated as the sum of z scores for each variable. Black participants lived in more disadvantaged areas than White participants [DIS mean (SD): 3.2 (4.3), -1.0 (3.2), p < .001]. Similar rates of abstinence were observed at the same level of disadvantage [DIS ≥ 50th percentile (less disadvantage): 21.9% Blacks, 26.2% Whites, p = .50; DIS < 50th percentile (more disadvantage): 10.7% Blacks, 15.8% Whites, p = .31]. Only DIS but neither race nor the interaction was retained in the final model predicting abstinence; each unit increase in DIS was associated with 9% reduced odds of abstinence, OR: 0.91, 95% CI [0.87,0.96]. Findings point to the importance of examining factors associated with race that contribute to health inequities and underscore the need to consider how consequences of systemic racism, such as neighborhood context and other consequences not captured by the DIS, can constrain or facilitate smoking cessation when developing interventions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

A Randomized Trial Evaluating Exercise for the Prevention of Weight Regain.

OBJECTIVE: This study aimed to evaluate the effectiveness of three levels of exercise on weight regain subsequent to clinically meaningful weight loss (WL). METHODS: Adults with overweight or obesity (n = 298) initiated a 3-month behavioral WL intervention, which included reduced energy intake, increased exercise, and weekly behavioral counseling. Participants achieving ≥5% WL (n = 235) began a 12-month behavioral WL maintenance intervention and were randomized to 150 min/wk (n = 76), 225 min/wk (n = 80), or 300 min/wk (n = 79) of partially supervised moderate-to-vigorous-intensity exercise. RESULTS: Participants randomized to 150, 225, and 300 minutes of exercise completed 129 ± 30, 153 ± 49 and 179 ± 62 min/wk of exercise (supervised + unsupervised), respectively. Mean WL at 3 months (9.5 ± 3.1 kg) was similar across randomized groups (P = 0.68). Weight change across 12 months was 1.1 ± 6.5 kg, 3.2 ± 5.7 kg, and 2.8 ± 6.9 kg in the 150, 225, and 300 min/wk groups, respectively. Intent-to-treat analysis revealed no significant overall trend across the three treatment groups (P = 0.09), effects for group (P = 0.08), or sex (P = 0.21). CONCLUSIONS: This study found no evidence for an association between the volume of moderate-to-vigorous-intensity exercise and weight regain across 12 months following clinically relevant WL. Further, results suggest that exercise volumes lower than those currently recommended for WL maintenance, when completed in conjunction with a behavioral weight-maintenance intervention, may minimize weight regain over 12 months.

Weight Loss Interventions for Adolescents With Intellectual Disabilities: An RCT.

OBJECTIVES: In this randomized trial, we compared the effectiveness of 2 diets (enhanced stop light diet [eSLD] versus conventional meal plan diet [CD]) and 2 delivery strategies (face-to-face [FTF] versus remote delivery [RD]) on weight loss across 6 months in adolescents with intellectual and developmental disabilities who were overweight or obese. METHODS: Participants were randomly assigned to 1 of 3 arms (FTF/CD, RD/CD, or RD/eSLD) and asked to attend one-on-one sessions with a health educator every 2 weeks to aid in maintaining compliance with recommendations for a reduced-energy diet and increased physical activity. The CD followed the US dietary guidelines. The eSLD used the stop light guide and was enhanced with portion-controlled meals. The FTF arm was delivered during in-person home visits. The RD arms were delivered by using video conferencing. RESULTS: A total of 110 adolescents with intellectual and developmental disabilities (aged ∼16 years, 53% female, BMI 33) were randomly assigned to the FTF/CD (n = 36), RD/CD (n = 39), or RD/eSLD (n = 35) group. Body weight at 6 months was obtained from 97%, 100%, and 86% of participants in the FTF/CD, RD/CD, and RD/eSLD arms, respectively. The eSLD elicited significantly greater weight loss than the CD: RD/eSLD (-5.0 ± 5.9 kg; -6.4%) versus RD/CD (-1.8 ± 4.0 kg; -2.4%) (P = .01). However, weight loss did not differ by delivery strategy: FTF/CD (-0.3 ± 5.0 kg; -0.2%) versus RD/CD (-1.8 ± 4.0 kg; -2.4%) (P = .20). CONCLUSIONS: The eSLD elicited significantly greater 6-month weight loss compared with a CD when both interventions were delivered remotely. Minimal 6-month weight loss, which did not differ significantly between FTF delivery and RD, was observed with a CD.