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We examined the effect of three components of self-determination—autonomy, empowerment, and self-realization—on the postsecondary enrollment of English learners with disabilities, using quasi-experimental propensity score modeling and data from the U.S. National Longitudinal Transition Study-2. Results support the hypothesis that self-determination components affect postsecondary school enrollment. English learners with disabilities with higher autonomy scores were more likely to enroll in 2-year colleges, and those with higher empowerment scores were more likely to enroll in 4-year colleges. However, prior research found that English learners with disabilities are less likely to act autonomously or report empowerment-related behaviors than other students with disabilities or students in the general population. Considering the increasing importance of postsecondary education, the current study’s findings demonstrate the importance of promoting both the self-determined behaviors of this dually identified population of students and the learning environment supports that facilitate the practice of self-determination.

Supplementary Table 1 from Nicotine Withdrawal Sensitivity, Linkage to chr6q26, and Association of OPRM1 SNPs in the SMOking in FAMilies (SMOFAM) Sample

Supplementary Table 2 from Nicotine Withdrawal Sensitivity, Linkage to chr6q26, and Association of OPRM1 SNPs in the SMOking in FAMilies (SMOFAM) Sample

1.0AbstractVaccines help reduce new infections, but interventions that can prevent the disease from transitioning to a severe stage are rather limited. Dysregulated IFN kinetics are mostly exploited by pathogenic viruses, including SARS-CoV-2. The clinical benefits of systemically infused IFN are, unfortunately, mired by undesired side effects. To address this situation, we engineered a T cell to synthesize interferons (IFNs) as antiviral proteins upon recognizing the virus envelop protein of SARS-CoV-2, i.e.,anti-SARS T-cell Biofactory. The T-cell Biofactory, capable of regulating the IFN expression with spatiotemporal resolution within the infected tissues, can mitigate these concerns. In this work, we determined the prophylactic and therapeutic effects of the type-I and type-III IFNs produced from the T-cell Biofactory against SARS-CoV-2 infection in host cells and investigated the expression profiles of ensuing IFN-stimulated genes (ISGs). To enable the translation of T-cell Biofactory as an effective antiviral countermeasure, we also investigated an irradiation dose that renders the T-cell Biofactory non-proliferative and thus non-oncogenic. The ongoing public health crisis motivated us to direct the T-cell Biofactory technology to target SARS-CoV-2. The T-cell Biofactory, based on T cells engineered with chimeric antigen receptors (CAR T cells), is a platform technology that can be rapidly re-engineered and become available for targeting any new pathogen.

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.

The NK-92MI, a fast-growing cytolytic cell line with a track record of exerting clinical efficacy, is transformed into a vector for synthesizing calibrated amounts of desired engineered proteins at our disease site, that is, NK-cell Biofactory. This provides an allogeneic option to the previously published T-cell-based living vector that is limited by high manufacturing cost and product variability. The modularity of this pathway, which combines a "target" receptor with an "effector" function, enables reprogramming of the NK-cell Biofactory to target diseases with specific molecular biomarkers, such as cancer, viral infections, or auto-immune disorders, and overcome barriers that may affect the advancement of NK-cell therapies.

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

Purpose: In a significant nuclear event, hundreds of thousands of individuals will require rapid triage for absorbed radiation to ensure effective medical treatment and efficient use of medical res...

In contrast to the increase in college enrollment rates of youth with learning disabilities (LD), graduation rates have remained stagnant and low. Using propensity methods, this study examined the effect of disability-specific and universally available support receipt on the college perseverance and completion of students with LD. Based on secondary analysis of National Longitudinal Transition Study 2 (NLTS2), findings indicate that students who received supports—those available to the full student body and/or disability-specific supports—were more likely to persist in, and successfully complete, 2-year or 4-year college. Implications include that transition staff need to ensure students not only are prepared to seek disability supports once on campus, but that equal emphasis should be placed on helping students access supports available to the full student body.

Introduction Genome-wide association studies consistently show that single nucleotide polymorphisms (SNPs) in the complement receptor 1 ( CR1 ) gene modestly but significantly alter Alzheimer's disease (AD) risk. Follow-up research has assumed that CR1 is expressed in the human brain despite a paucity of evidence for its function there. Alternatively, erythrocytes contain >80% of the body's CR1, where, in primates, it is known to bind circulating pathogens. Methods Multidisciplinary methods were employed. Results Conventional Western blots and quantitative polymerase chain reaction failed to detect CR1 in the human brain. Brain immunohistochemistry revealed only vascular CR1. By contrast, erythrocyte CR1 immunoreactivity was readily observed and was significantly deficient in AD, as was CR1-mediated erythrocyte capture of circulating amyloid β peptide. CR1 SNPs associated with decreased erythrocyte CR1 increased AD risk, whereas a CR1 SNP associated with increased erythrocyte CR1 decreased AD risk. Discussion SNP effects on erythrocyte CR1 likely underlie the association of CR1 polymorphisms with AD risk.

This study evaluated the feasibility and efficacy of integrating mindfulness training into a phone-based weight loss program to improve outcomes in those with high levels of emotional eating. Participants were 75 enrollees into an employer-sponsored weight loss program who reported high levels of overeating in response to thoughts and feelings. Seventy-five overweight and obese participants (92% female, 65% Caucasian, aged 26 to 68years) were randomized to the new mindfulness weight loss program (n = 50) or the standard behavioral weight loss program (n = 25). Both programs consisted of 11 coaching calls with health coaches and registered dietitians with supplemental online materials. Satisfaction, engagement, and percent weight lost did not significantly differ for intervention vs. control at six months. Intervention participants had significantly better scores at six-month follow-up on mindful eating, binge eating, experiential avoidance, and one mindfulness subscale. Exploratory analyses showed that improvements on several measures predicted more weight loss in the intervention group. This pilot study found that integrating mindfulness into a brief phone-based behavioral weight loss program was feasible and acceptable to participants, but did not produce greater weight loss on average, despite hypothesized changes in mindful eating. Only one third of intervention participants reported participating in mindfulness exercises regularly. Mechanisms of change observed within the intervention group suggest that for adults with high levels of emotional eating those who embrace mindful eating and meditation may lose more weight with a mindfulness intervention.

OBJECTIVES. Insomnia disorder is a risk factor for cardiovascular pathology. It is unknown whether insomnia that develops in the context of the menopausal transition impacts the cardiovascular system. We assessed nocturnal blood pressure and heart rate profiles in women with insomnia disorder in the menopausal transition. METHODS. Twelve women meeting DSM-IV criteria for insomnia in the menopausal transition (Age, mean±SD: 50.5±3.6y) and eleven controls (Age, mean±SD: 49.0±3.0y) had polysomnographic recordings on one or two nights during which beat-to-beat blood pressure and heart rate were assessed and analyzed hourly from lights-out across the first 6h of the night and according to sleep stage. Physiological hot flashes were identified from fluctuations in sternal skin conductance. RESULTS. Women with insomnia and controls had similar distributions of sleep stages and awakenings/arousals across hours of the night, although insomnia participants tended to have more wakefulness overall. More women in the insomnia group (7 of 12) than in the control group (2 of 11) had at least one physiological hot flash at night (p

Purpose The aim of the study was to investigate associations between sleep disturbances and mental health in adolescents. Methods Data are from a national sample of 11,670 U.S. participants (5,594 females, aged 9–10 years, 63.5% white) in the Adolescent Brain Cognitive Development study. Initial longitudinal analyses were conducted for a subset of the sample (n = 4,951). Measures of youth sleep disturbance (disorders of initiating and maintaining sleep, sleep–wake transition disorders, and disorders of excessive somnolence) and “typical” total sleep time (number of hours slept on most nights in the past 6 months) were obtained from the parent-report Sleep Disturbance Scale (Data Release 2.0). Parent-report measures of youth mental health (depression, internalizing, and externalizing behaviors) from the Child Behavior Checklist and typical screen time were included. Results At baseline, greater sleep disturbance and shorter total sleep time were associated with greater internalizing, externalizing, and depression scores. After controlling for baseline mental health symptoms, baseline sleep disturbance significantly predicted depression and internalizing and externalizing scores at 1-year follow-up. A significant interaction with sex indicated that the association between disorders of excessive somnolence and depression 1 year later was steeper for girls, compared with boys (p Conclusions Sleep disturbances predicted future mental health, particularly depression in this young sample, highlighting the potential to harness sleep as a tool to mitigate the persistence of depression across early adolescence and potentially prevent an adolescent onset of major depressive disorder.

Study Objectives To investigate the pre-sleep psychophysiological state and the arousal deactivation process across the sleep onset (SO) transition in adolescents. Methods Data were collected from a laboratory overnight recording in 102 healthy adolescents (48 girls, 12–20 years old). Measures included pre-sleep self-reported cognitive/somatic arousal, and cortical electroencephalographic (EEG) and electrocardiographic activity across the SO transition. Results Adolescent girls, compared with boys, reported higher pre-sleep cognitive activation (p = 0.025) and took longer to fall asleep (p Conclusions Our findings show the dynamics of the cortical-cardiac de-arousing process across the SO transition in a non-clinical sample of healthy adolescents. Findings suggest a female-specific vulnerability to inefficient sleep initiation, which may contribute to their greater risk for developing insomnia.

A set of genetically engineered isogenic cell lines is developed to express either folate receptor alpha or mesothelin, and a control cell line negative for both antigens. These cell lines also express fluorescent and bioluminescent reporter transgenes. The cell lines are used to authenticate specificity and function of a T-cell biofactory, a living vector that is developed to express proportionate amounts of engineered proteins upon engaging with disease cells through their specific antigenic biomarkers. The engineered cell lines are also used to assess the cytolytic function and specificity of primary T cells engineered with chimeric antigen receptors; and the specificity of monoclonal antibodies. The strategy described can be used to generate other cell lines to present different disease-specific biomarkers for use as quality control tools.

Hot flashes (HFs) are a hallmark of menopause in midlife women. They are beyond bothersome symptoms, having a profound impact on quality of life and wellbeing, and are a potential marker of cardiovascular (CV) disease risk. Here, we investigated the impact on CV functioning of single nocturnal HFs, considering whether or not they were accompanied by arousals or awakenings. We investigated changes in heart rate (HR, 542 HFs), blood pressure (BP, 261 HFs), and pre-ejection period (PEP, 168 HFs) across individual nocturnal physiological HF events in women in the menopausal transition or post-menopause (age: 50.7 ± 3.6 years) (n = 86 for HR, 45 for BP, 27 for PEP). HFs associated with arousals/awakenings (51.1%), were accompanied by an increase in systolic (SBP; ~6 mmHg) and diastolic (DBP; ~5 mmHg) BP and HR (~20% increase), sustained for several minutes. In contrast, HFs occurring in undisturbed sleep (28.6%) were accompanied by a drop in SBP and a marginal increase in HR, likely components of the heat dissipation response. All HFs were accompanied by decreased PEP, suggesting increased cardiac sympathetic activity, with a prolonged increase for HFs associated with sleep disruption. Older age predicted greater likelihood of HF-related sleep disturbance. HFs were less likely to wake a woman in rapid-eye-movement and slow-wave sleep. Findings show that HFs associated with sleep disruption, which are in the majority and more likely in older women, lead to increases in HR and BP, which could have long-term impact on nocturnal CV restoration in women with multiple HFs.

An artificial cell-signaling pathway is developed that capitalizes on the T-cell's innate extravasation ability and transforms it into a vector (T-cell Biofactory) for synthesizing calibrated amounts of engineered proteins in vivo. The modularity of this pathway enables reprogramming of the T-cell Biofactory to target biomarkers on different disease cells, e.g. cancer, viral infections, autoimmune disorders. It can be expected that the T-cell Biofactory leads to a "living drug" that extravasates to the disease sites, assesses the disease burden, synthesizes the calibrated amount of engineered therapeutic proteins upon stimulation by the diseased cells, and reduces targeting of normal cells.

Data from the National Longitudinal Transition Study-2 were used to examine the effect of academic and career or technical education course-taking in high school on deaf or hard of hearing (DHH) youth’s postsecondary enrollment in 2-year, 4-year, and career or technical education institutions. We examined the proportion of academic and career or technical education courses taken, completion of algebra, and completion of an occupationally specific course of study. Propensity model analyses indicated that academic course taking significantly increased the odds that DHH students would enroll in postsecondary school. Completion of a higher proportion of career or technical education courses was not related to enrollment in postsecondary education, including career and technical education schools. Implications for practice and future research are discussed, including the importance of secondary transition planning staff both encouraging DHH students who have a goal of future postsecondary attendance to...

STUDY OBJECTIVES To investigate age-related differences in polysomnographic and sleep electroencephalographic (EEG) measures, considering sex, pubertal stage, ethnicity, and scalp topography in a large group of adolescents in the National Consortium on Alcohol and NeuroDevelopment in Adolescence (NCANDA). METHODS Following an adaptation/clinical screening night, 141 healthy adolescents (12-21 y, 64 girls) had polysomnographic recordings, from which sleep staging and EEG measures were derived. The setting was the SRI International Human Sleep Laboratory and University of Pittsburgh Pediatric Sleep Laboratory. RESULTS Older age was associated with a lower percentage of N3 sleep, accompanied by higher percentages of N2, N1, and rapid eye movement (REM) sleep. Older boys compared with younger boys had more frequent awakenings and wakefulness after sleep onset, effects that were absent in girls. Delta (0.3-4 Hz) EEG power in nonrapid eye movement NREM sleep was lower in older than younger adolescents at all electrode sites, with steeper slopes of decline over the occipital scalp. EEG power in higher frequency bands was also lower in older adolescents than younger adolescents, with equal effects across electrodes. Percent delta power in the first NREM period was similar across age. African Americans had lower EEG power across frequency bands (delta to sigma) compared with Caucasians. Finally, replacing age with pubertal status in the models showed similar relationships. CONCLUSIONS Substantial differences in sleep architecture and EEG were evident across adolescence in this large group, with sex modifying some relationships. Establishment and follow-up of this cohort allows the investigation of sleep EEG-brain structural relationships and the effect of behaviors, such as alcohol and substance use, on sleep EEG maturation.

Introduction: Metabolic enzyme variation and other patient and environmental characteristics influence smoking behaviors, treatment success, and risk of related disease. Population-specific variation in metabolic genes contributes to challenges in developing and optimizing pharmacogenetic interventions. We applied a custom genome-wide genotyping array for addiction research (Smokescreen), to three laboratory-based studies of nicotine metabolism with oral or venous administration of labeled nicotine and cotinine, to model nicotine metabolism in multiple populations. The trans-3′-hydroxycotinine/cotinine ratio, the nicotine metabolite ratio (NMR), was the nicotine metabolism measure analyzed. Methods: Three hundred twelve individuals of self-identified European, African, and Asian American ancestry were genotyped and included in ancestry-specific genome-wide association scans (GWAS) and a meta-GWAS analysis of the NMR. We modeled natural-log transformed NMR with covariates: principal components of genetic ancestry, age, sex, body mass index, and smoking status. Results: African and Asian American NMRs were statistically significantly (P values ≤ 5E-5) lower than European American NMRs. Meta-GWAS analysis identified 36 genome-wide significant variants over a 43 kilobase pair region at CYP2A6 with minimum P = 2.46E-18 at rs12459249, proximal to CYP2A6. Additional minima were located in intron 4 (rs56113850, P = 6.61E-18) and in the CYP2A6-CYP2A7 intergenic region (rs34226463, P = 1.45E-12). Most (34/36) genome-wide significant variants suggested reduced CYP2A6 activity; functional mechanisms were identified and tested in knowledge-bases. Conditional analysis resulted in intergenic variants of possible interest (P values < 5E-5). Conclusions: This meta-GWAS of the NMR identifies CYP2A6 variants, replicates the top-ranked single nucleotide polymorphism from a recent Finnish meta-GWAS of the NMR, identifies functional mechanisms, and provides pan-continental population biomarkers for nicotine metabolism. Implications: This multiple ancestry meta-GWAS of the laboratory study-based NMR provides novel evidence and replication for genome-wide association of CYP2A6 single nucleotide and insertion–deletion polymorphisms. We identify three regions of genome-wide significance: proximal, intronic, and distal to CYP2A6. We replicate the top-ranking single nucleotide polymorphism from a recent GWAS of the NMR in Finnish smokers, identify a functional mechanism for this intronic variant from in silico analyses of RNA-seq data that is consistent with CYP2A6 expression measured in postmortem lung and liver, and provide additional support for the intergenic region between CYP2A6 and CYP2A7.

A process for maximizing the titer of lentivirus particles, deemed to be a necessity for transducing primary cells, has been developed. Lentivirus particles, with a set of transgenes encoding an artificial cell-signaling pathway, were used to transform primary T cells as vectors for calibrated synthesis of desired proteins in situ, i.e. T-cell Biofactory cells. The process was also used to generate primary T cells expressing antigen-specific chimeric antigen receptors, i.e. CAR T cells. The two differenty engineered primary T cells were expanded and validated for their respective functions, i.e. calibrated synthesis of desired proteins upon engaging the target cells, which was specific for the T-cell Biofactory cells; and cytolysis of the target cells common to both types of cells. The process is compliant with current Good Manufacturing Practices (cGMP) and can be used to support the scale up for clinical translation.

Purpose: There is a need to rapidly triage individuals for absorbed radiation dose following a significant nuclear event. Since most exposed individuals will not have physical dosimeters, we are de...

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

Data from the National Longitudinal Transition Study–2 (NLTS2) were used to examine the patterns of career and technical education (CTE) course taking in high school by students receiving special education services for emotional disturbances (ED). Descriptive analyses indicate the extent of such course taking by students with ED and their engagement in a concentrated program of occupationally specific general education CTE, a level of CTE course taking that early research has linked to improved post–high school employment outcomes. Propensity scoring methods were used to determine the extent to which either type of CTE course taking was related to higher odds of full-time employment after high school and whether results differed with the length of time post high school. There was a significant positive effect for participating in a concentration of occupationally specific CTE in the first 2 post–high school years, but effects were non-significant for later years. Results showed no benefits of CTE course taking overall. The implications for high school programming and transition planning are discussed.

The authors of this article analyzed data from the National Longitudinal Transition Study-2 to determine the effect of receiving transition planning education and having a transition plan that specified needed postsecondary accommodations on the receipt of disability-specific services and generally available supports at the postsecondary level by students with disabilities. Propensity model analyses indicated that both variables significantly increased the odds that students with disabilities would receive disability-specific and generally available supports at 2-year institutions. In addition, students with transition plans specifying accommodations were more likely to receive disability-related supports at career and technical education (CTE) schools, and CTE students who had received transition planning education in high school were more likely to receive generally available supports. The results provide important implications for policy and practice, and a strong foundation for further exploration of the linkages between transition planning experiences and receipt of disability-specific and generally available supports at postsecondary schools.

This study used propensity score techniques to assess the relationship between transition planning participation and goal-setting and college enrollment among youth with Autism Spectrum Disorders. Using data from Waves 1 through 5 of the National Longitudinal Transition Study–2, this study found that 2- or 4-year college enrollment rates were significantly higher among youth with ASDs who participated in transition planning and those who had a primary transition goal of college enrollment. Educational implications are discussed.

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 5082 potentially eligible callers to a tobacco quitline, 2540 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

PURPOSE. We assessed sex- and age-dependent differences in a cross-sectional analysis of cardiac autonomic nervous system (ANS) regulation during sleep in adolescents. METHODS. Nocturnal heart rate (HR) and heart rate variability (HRV) metrics, reflecting ANS functioning, were analyzed across the night and within undisturbed rapid-eye movement (REM) and non-REM (NREM) sleep in 149 healthy adolescents (12–22y; 67 female) from the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA). RESULTS. Nocturnal HR was slower in older, more pubertally-advanced boys than younger boys. In girls, HR did not vary according to age or maturity, although overall HRV and vagal modulation declined with age. While younger boys and girls had similar HR, the male-female HR difference increased by ~2.4bpm every year (p

First Step to Success (First Step; Walker et al., 1997, 1998) is a secondary-level intervention for students with behavior problems in early elementary school. The purposes of this study were to as...

Using data from the National Longitudinal Transition Study–2, this study considers (a) the extent to which the socioeconomic status (SES) of youth with disabilities predicted their likelihood of high school graduation, postsecondary education enrollment, and employment; (b) the extent to which other individual and family factors mediated the SES–outcome relationships; and (c) other factors that significantly explained outcome variations for youth with disabilities. Results show that SES had a statistically significant but relatively small effect on outcomes, to a sizable extent the effect of SES was mediated by other factors, and many of the covariates in the analyses (e.g., disability type and severity, gender, race/ethnicity) had their own significant relationships with outcomes that contribute to our understanding of variations in them.

Although numerous studies address the efficacy of school-based interventions, fewer focus on how to support sustainability of interventions from the perspective of participants. To address this research gap, we use the Practical, Robust Implementation and Sustainability Model to examine how the characteristics of an evidence-based program interact with those of participants (i.e., students, parents, educators) to influence program implementation and continuation. Specifically, we consider lessons learned in one site of the national effectiveness study of First Step to Success which sustained implementation in a majority of participating schools after the study ceased. First, we analyze implementation fidelity and its effects on students’ behavioral and academic outcome data. Then, we analyze focus group and interview data collected from participants 2 years after initial implementation to consider contextual factors associated with continued program success, including (a) the nature of the intervention, (b) the external environment, (c) implementation and sustainability infrastructure, and (d) participant characteristics.

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 Electronic supplementary material The online version of this article (doi:10.1186/s12889-016-3231-6) contains supplementary material, which is available to authorized users.