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1.  A Novel Recruitment Message to Increase Enrollment into a Smoking Cessation Treatment Program: Preliminary Results from a Randomized Triala 
Health communication  2011;26(8):735-742.
Most smokers do not utilize approved interventions for nicotine dependence, reducing the probability of cessation. Smoking cessation programs typically use recruitment messages emphasizing the health threats of smoking. Augmenting this threat message by describing the genetic aspects of nicotine addiction may enhance enrollment into a cessation program. During telephone recruitment, 125 treatment-seeking smokers were randomized to receive by phone either a standard threat message or a threat plus genetic prime message and were offered open-label varenicline and counseling. There was a greater rate of enrollment into the cessation program for the threat plus genetic prime participants (51.7%) vs. the threat-only participants (37.7%; p = .03). Smokers who self-identified from racial/ethnic minority groups were less likely to enroll in the cessation program (p = .01) vs. smokers who self-identified as Caucasian. These preliminary data suggest that a simple, affordable, and transportable communication approach enhances enrollment of smokers into a smoking cessation program. A larger clinical trial to evaluate a genetic prime message for improving recruitment into smoking cessation programs is warranted.
PMCID: PMC4243839  PMID: 21667366
2.  APOE ε4, an Alzheimer’s disease susceptibility allele, and smoking cessation 
The pharmacogenomics journal  2012;13(6):10.1038/tpj.2012.49.
Possessing an APOE ε4 allele, advanced age, and smoking are risk factors for Alzheimer’s disease and cognitive decline. Deficits in cognitive function also increase risk for smoking relapse. Data from 917 adult smokers of European ancestry were pooled across three randomized trials of smoking cessation. We examined whether smokers who carry at least one ε4 allele (n=252) have more difficulty quitting smoking compared to noncarriers (n=665), and whether age moderated this association. The genotype by age interaction was significant for 7-day point-prevalence abstinence rates (p=0.04) and time to 7-day failure (p=0.03). Among smokers over age 60, ε4 carriers were less likely to quit (OR=0.27, p=0.018) and relapsed more quickly (HR=3.38, p=0.001) compared to noncarriers. The genotype association with relapse was non-significant among younger smokers. An increased understanding of the underlying pathophysiological mechanisms of this association could facilitate the development of targeted therapies for smokers with increased risk for cognitive decline.
PMCID: PMC3604077  PMID: 23247396
smoking; smoking cessation; relapse; nicotine; cognition; APOE
3.  Development and Validation of the Weight Control Strategies Scale 
Obesity (Silver Spring, Md.)  2013;21(12):10.1002/oby.20368.
To develop and validate the Weight Control Strategies Scale (WCSS), a self-report instrument to assess use of specific behaviors thought to facilitate weight loss.
Design and Methods
Factor analysis was conducted on 323 overweight and obese adults (mean age=48.7±10.9 years, mean BMI=35.4±4.9 kg/m2, 74% female) enrolled in three different behavioral weight loss trials who completed the WCSS prior to starting treatment. To evaluate construct validity, additional data on dietary intake, physical activity, treatment session attendance, and weight change were obtained from a subsample of participants before and after participation in a 48-week weight loss program.
Principal components analysis with varimax rotation revealed a four component solution for the WCSS, representing the following subscales: Dietary Choices, Self-monitoring Strategies, Physical Activity, and Psychological Coping (a’s from 0.79–0.89). Longitudinal analyses showed that WCSS subscale scores increased during treatment (p’s <0.01). In adjusted models, changes in WCSS total and subscale scores were associated with posttreatment weight loss (p’s <0.01). Additionally, changes in WCSS Dietary Choices and Physical Activity subscales were related to posttreatment changes in total daily kilocalorie consumption (p=0.019) and weekly kilocalorie expenditure through physical activity (p<0.001), respectively.
Findings support the validity and reliability of the WCSS in a weight loss treatment seeking sample.
PMCID: PMC3778038  PMID: 23512914
4.  The effect of weight loss on changes in health-related quality of life among overweight and obese women with urinary incontinence 
To estimate the effect of change in weight and change in urinary incontinence (UI) frequency on changes in preference-based measures of health-related quality of life (HRQL) among overweight and obese women with UI participating in a weight loss trial.
We conducted a longitudinal cohort analysis of 338 overweight and obese women with UI enrolled in a randomized clinical trial comparing a behavioral weight loss intervention to an educational control condition. At baseline, 6, and 18 months, health utilities were estimated using the Health Utilities Index Mark 3 (HUI3), a transformation of the SF-36 to the preference-based SF-6D, and the estimated Quality of Well-Being (eQWB) score (a summary calculated from the SF-36 physical functioning, mental health, bodily pain, general health perceptions, and role limitations-physical subscale scores). Potential predictors of changes in these outcomes were examined using generalized estimating equations.
In adjusted multivariable models, weight loss was associated with improvement in HUI3, SF-6D, and eQWB at 6 and 18 months (p<.05). Increases in physical activity also were independently associated with improvement in HUI3 (p=.01) and SF-6D (p=.006) scores at 18 months. In contrast, reduction in UI frequency did not predict improvements in HRQL at 6 or 18 months.
Weight loss and increased physical activity, but not reduction in UI frequency, were strongly associated with improvements in health utilities measured by the HUI3, SF-6D, and eQWB. These findings provide important information that can be used to inform cost-utility analyses of weight loss interventions.
PMCID: PMC3375350  PMID: 22161726
quality of life; weight loss; urinary incontinence; HUI; eQWB; SF-6D
5.  Combining behavioral weight loss treatment and a commercial program: A randomized clinical trial 
Obesity (Silver Spring, Md.)  2013;21(4):673-680.
Commercial weight loss programs such as Weight Watchers (WW) offer widely recognized and accessible treatment, but typically produce weight losses that are modest relative to professionally delivered programs. This study tested the hypothesis that a novel weight loss approach that combined the fundamental components of professionally delivered behavioral weight loss (BWL) treatment with the existing WW program would produce better weight losses than WW alone; no differences were expected between the novel treatment and BWL alone. Participants were 141 overweight and obese adults (90% women, 67% non-White, mean age = 49.7 ± 9.2 years, mean BMI = 36.2 ± 5.5 kg/m2) randomly assigned to 48 weeks of BWL, 48 weeks of WW, or 12 weeks of BWL followed by 36 weeks of WW (Combined Treatment, CT). Assessments were conducted at baseline and weeks 12, 24, and 48, with weight change as the primary outcome. Linear mixed model analysis showed that 24-week weight losses did not differ significantly between treatment groups; however, weight losses at 48 weeks were greater in the WW group (M=6.0 kg, SE=0.8) compared to the CT group (M=3.6 kg, SE=0.8; p=0.032), with BWL not significantly different from either (M=5.4 kg, SE=0.8). Further, a greater proportion of WW participants lost 10% of baseline weight by 48 weeks compared to BWL or CT (36.7%, 13.0%, and 15.2%, respectively, p’s<0.05). This study shows that the WW program can produce clinically meaningful weight losses and provides no evidence that adding brief BWL to the WW program improves outcome.
PMCID: PMC3657569  PMID: 23404824
6.  Decrease in Urinary Incontinence Management Costs in Women Enrolled in a Clinical Trial of Weight Loss to Treat Urinary Incontinence 
Obstetrics and Gynecology  2012;120(2 Pt 1):277-283.
To estimate the effect of a decrease in urinary incontinence frequency on urinary incontinence management costs among women enrolled in a clinical trial of a weight loss intervention and to identify factors that predict change in cost.
This is a secondary cohort analysis of 338 obese and overweight women with ≥ 10 weekly episodes of urinary incontinence enrolled in an 18-month randomized clinical trial of a weight loss intervention compared to a structured education program to treat urinary incontinence. Quantities of resources used for incontinence management, including pads, additional laundry, and dry cleaning were reported by participants. Direct costs for urinary incontinence management (“cost”) were calculated by multiplying resources used by national resource costs (in 2006 U.S. dollars). Randomized groups were combined to examine the effects of change in incontinence frequency on cost. Possible predictors of change in cost were examined using generalized estimating equations controlling for factors associated with change in cost in univariable analyses.
Mean (±SD) age was 53±10 years and baseline weight was 97+17 kg. Mean weekly urinary incontinence frequency was 24+18 at baseline and decreased by 37% at 6 months and 60% at 18 months follow-up (both P<0.001). At baseline, adjusted mean cost was $7.76±$14 per week, with costs increasing significantly with greater incontinence frequency. Mean cost decreased by 54% at 6 months and 81% at 18 months (both P<0.001). In multivariable analyses, cost independently decreased by 23% for each decrease of seven urinary incontinence episodes per week and 21% for each 5 kg of weight lost (P<0.001 for both).
In obese and overweight women enrolled in a clinical trial of weight loss for urinary incontinence, incontinence management cost decreased by 81% at 18 months ($327 per woman per year) and was strongly and independently associated with decreasing incontinence frequency.
PMCID: PMC3404427  PMID: 22825085
7.  A Statewide Intervention Reduces BMI in Adults: Shape Up Rhode Island Results 
Obesity (Silver Spring, Md.)  2009;17(5):991-995.
Given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. We report results from Shape Up Rhode Island 2007 (SURI), a state-wide Internet based program involving team-based competition to increase physical activity and achieve weight loss. A total of 4,717 adults (84% female; mean BMI = 29.6 kg/m2) enrolled in the 16 week weight loss competition of SURI and 3311 completed at least 12 weeks. Completers reported losing 3.2 ± 3.4 kg, and 30% achieved a clinically significant weight loss of 5% or more. Although modest, these weight losses shifted the BMI distribution from a mean BMI of 29.4 to 28.2 kg/m2 and reduced the population that was obese from 39% to 31%. More conservative intent-to-treat analyses and analysis of 132 participants with objective weights still showed a significant reduction in BMI of −0.8 units. These findings suggest that state-wide weight loss campaigns can produce modest weight losses in large numbers of participants. These data provide a bench-mark that can be used for comparisons with other state-wide campaigns. Research on ways to improve such campaigns is needed.
PMCID: PMC3708457  PMID: 19180068
8.  The Value of Removing Daily Obstacles via Everyday Problem-Solving Theory: Developing an Applied Novel Procedure to Increase Self-Efficacy for Exercise 
The objective of the study was to develop a novel procedure to increase self-efficacy for exercise. Gains in one’s ability to resolve day-to-day obstacles for entering an exercise routine were expected to cause an increase in self-efficacy for exercise. Fifty-five sedentary participants (did not exercise regularly for at least 4 months prior to the study) who expressed an intention to exercise in the near future were selected for the study. Participants were randomly assigned to one of three conditions: (1) an Experimental Group in which they received a problem-solving training session to learn new strategies for solving day-to-day obstacles that interfere with exercise, (2) a Control Group with Problem-Solving Training which received a problem-solving training session focused on a typical day-to-day problem unrelated to exercise, or (3) a Control Group which did not receive any problem-solving training. Assessment of obstacles to exercise and perceived self-efficacy for exercise were conducted at baseline; perceived self-efficacy for exercise was reassessed post-intervention (1 week later). No differences in perceived challenges posed by obstacles to exercise or self-efficacy for exercise were observed across groups at baseline. The Experimental Group reported greater improvement in self-efficacy for exercise compared to the Control Group with Training and the Control Group. Results of this study suggest that a novel procedure that focuses on removing obstacles to intended planned fitness activities is effective in increasing self-efficacy to engage in exercise among sedentary adults. Implications of these findings for use in applied settings and treatment studies are discussed.
PMCID: PMC3557456  PMID: 23372560
self-efficacy; physical activity; everyday problem-solving theory; everyday problem-solving training; idiosyncratic methods
9.  Comparison and correlates of three preference-based health-related quality-of-life measures among overweight and obese women with urinary incontinence 
To compare three preference-based health-related quality-of-life (HRQL) measures and examine independent correlates of HRQL among overweight and obese women with urinary incontinence (UI) enrolled in a weight loss intervention trial.
Participants completed baseline questionnaires, which included the Health Utilities Index 3 (HUI3) and Medical Outcomes Study Short Form-36 (SF-36). The SF-36 was used to derive SF-6D and estimated Quality of Well-Being (eQWB) scores. Height, weight, medical history, incontinence measures, and level of physical activity also were assessed. The intraclass correlation coefficient (ICC) was computed, and differences in mean scores across HRQL measures were examined. Potential correlates of HUI3, SF-6D, and eQWB scores were evaluated using multivariable generalized linear models.
Mean ± SD scores for the HUI3, SF-6D, and eQWB were 0.81 ± 0.18, 0.75 ± 0.10, and 0.71 ± 0.06, respectively. Significant differences were observed across measures (P < 0.0001), and the overall ICC was 0.36. In multivariable analyses, BMI was negatively associated with HUI3 (P = 0.003) and eQWB (P < 0.001), and UI episode frequency was negatively associated with eQWB (P = 0.015) and SF-6D (P < 0.001).
Significant differences in mean utilities across the HUI3, SF-6D, and eQWB indicate that these measures do not assess identical dimensions of HRQL. Both BMI and UI episode frequency were related to HRQL in this cohort; however, the magnitude of the relationship depended on the preference-based measure used. These findings highlight the need to consider the method used to generate HRQL values for calculating quality-adjusted life-years in cost-utility analyses, since choice of method may have a substantial impact on the outcome of the analysis.
PMCID: PMC3174313  PMID: 21461953
Quality of life; Obesity; Urinary incontinence; HUI; eQWB; SF-6D
10.  Occurrence of Ochratoxin A in the Wild Boar (Sus scrofa): Chemical and Histological Analysis 
Toxins  2012;4(12):1440-1450.
Ochratoxins are fungal secondary metabolites that may contaminate a broad variety of foodstuffs, such as grains, vegetables, coffee, dried fruits, beer, wine and meats. Ochratoxins are nephrotoxins, carcinogens, teratogens and immunotoxins in rats and are also likely to be in humans. In 2009/2010, a survey of the presence of Ochratoxin A (OTA) in regularly hunted wild boars in the Calabria region of southern Italy detected OTA in 23 animals in the kidney, urinary bladder, liver and muscles: 1.1 ± 1.15, 0.6 ± 0.58, 0.5 ± 0.54 and 0.3 ± 0.26 μg/kg, respectively. Twelve tissue samples showed levels of OTA higher than the guideline level (1 μg/kg) established by the Italian Ministry of Health. In five wild boars, gross-microscopic lesions were described for the organs displaying the highest concentrations of OTA determined by HPLC-FLD analysis, i.e., the kidney, liver and urinary bladder.
PMCID: PMC3528255  PMID: 23211797
ochratoxin A; Sus scrofa; wild boar
11.  Association of the Nicotine Metabolite Ratio and CHRNA5/CHRNA3 Polymorphisms With Smoking Rate Among Treatment-Seeking Smokers 
Nicotine & Tobacco Research  2011;13(6):498-503.
Genome-wide association studies have linked single-nucleotide polymorphisms (SNPs) in the CHRNA5/A3/B4 gene cluster with heaviness of smoking. The nicotine metabolite ratio (NMR), a measure of the rate of nicotine metabolism, is associated with the number of cigarettes per day (CPD) and likelihood of cessation. We tested the potential interacting effects of these two risk factors on CPD.
Pretreatment data from three prior clinical trials were pooled for analysis. One thousand and thirty treatment seekers of European ancestry with genotype data for the CHRNA5/A3/B4 SNPs rs578776 and rs1051730 and complete data for NMR and CPD at pretreatment were included. Data for the third SNP, rs16969968, were available for 677 individuals. Linear regression models estimated the main and interacting effects of genotype and NMR on CPD.
We confirmed independent associations between the NMR and CPD as well as between the SNPs rs16969968 and rs1051730 and CPD. We did not detect a significant interaction between NMR and any of the SNPs examined.
This study demonstrates the additive and independent association of the NMR and SNPs in the CHRNA5/A3/B4 gene cluster with smoking rate in treatment-seeking smokers.
PMCID: PMC3103715  PMID: 21385908
12.  Nicotine metabolite ratio predicts smoking topography and carcinogen biomarker level 
Variability in smoking behavior is partly attributable to heritable individual differences in nicotine clearance rates. This can be assessed as the ratio of the metabolites cotinine (COT) and 3'-hydroxycotinine (3HC) (referred to as the nicotine metabolism ratio, NMR). We hypothesized that faster NMR would be associated with greater cigarette puff volume and higher levels of total NNAL, a carcinogen biomarker.
Current smokers (n=109) smoked one of their preferred brand cigarettes through a smoking topography device and provided specimens for NMR and total NNAL assays.
Faster nicotine metabolizers (third and fourth quartiles versus first quartile) based on the NMR exhibited significantly greater total puff volume and total NNAL; the total puff volume by daily cigarette consumption interaction was a significant predictor of total NNAL level.
A heritable biomarker of nicotine clearance predicts total cigarette puff volume and total NNAL.
If validated, the NMR could contribute to smoking risk assessment in epidemiological studies and potentially in clinical practice.
PMCID: PMC3077576  PMID: 21212060
13.  Effect of teammates on changes in physical activity in a statewide campaign 
Preventive medicine  2010;51(1):45-49.
Most Americans do not meet physical activity recommendations. Statewide campaigns can effectively increase activity levels. Reported herein are physical activity outcomes from Shape Up Rhode Island (SURI) 2007, a statewide campaign to increase steps through team-based competition. Given the importance of social networks in behavior change, this paper focused on the effects of team and team characteristics on activity outcomes.
For 16-weeks, 5333 adults comprising 652 teams wore pedometers and reported their steps online.
Participants’ daily steps increased from 7029(3915) at baseline to 9393(5976) at SURI end (p<.001). There was a significant intraclass correlation for step change among team members (ICC=.09); thus, an individual’s change in steps was influenced by what team they were on. Moreover, baseline team characteristics predicted individual step change; being on a more active team was associated with greater increases in activity for individual members (p<.001), whereas being on a team with a broad range of steps was associated with smaller changes in activity for individual members (p=.02).
These findings are the first to suggest that team members influence individual activity outcomes in team-based statewide campaigns. Future research should explore ways to use social network factors to enhance team-based physical activity programs.
PMCID: PMC2885551  PMID: 20394768
statewide pedometer intervention; physical activity; social networks; social influence
14.  Evidence for endogenous formation of N′-nitrosonornicotine in some long-term nicotine patch users 
Nicotine & Tobacco Research  2009;11(1):99-105.
Nitrosation of nicotine or its metabolites in the human body could lead to formation of the 2 carcinogenic tobacco-specific nitrosamines—N′-nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK).
We investigated the possibility of endogenous formation of NNN in people who had stopped smoking and used the 21-mg nicotine patch for 6 months. We quantified urinary biomarkers of exposure to NNN—the sum of NNN and its pyridine-N-glucuronide, referred to as total NNN. Also measured were NNK metabolites—the sum of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and its N- and O-glucuronides, referred to as total NNAL.
The average decline of urinary total NNN was less drastic than that of total NNAL: 22% of baseline total NNN and 7.3% of baseline total NNAL were detected in urine 24 weeks after smoking cessation and patch use (p = .02). The average ratio of total NNN to total NNAL in the same urine samples increased from 0.14 in baseline urine to 0.38 after 24 weeks of nicotine patch use.
Overall, these results demonstrate that endogenous formation of NNN may occur in nicotine patch users. However, the levels of urinary total NNN during patch use were generally extremely low. Moreover, in 10 of 20 subjects analyzed here, the rate of decline in total NNN was similar to that in total NNAL, indicating that endogenous formation of NNN is virtually nonexistent in these subjects. Supplementation with ascorbic acid could be a simple approach to block possible NNN formation in nicotine patch users.
PMCID: PMC2734288  PMID: 19246447
15.  A Placebo-Controlled Trial of Modafinil for Nicotine Dependence 
Drug and alcohol dependence  2008;98(1-2):86-93.
Nicotine deprivation symptoms, including fatigue and attentional deficits, predict relapse following smoking cessation. Modafinil (Provigil), a wakefulness medication shown to have efficacy for the treatment of cocaine addiction, was tested as a novel therapy for nicotine dependence in a double-blind placebo-controlled trial.
157 treatment-seeking smokers received brief smoking cessation counseling and were randomized to: 1) 8 weeks of modafinil (200mg/day), or 2) 8 weeks of placebo. The primary outcome was biochemically verified 7-day point prevalence abstinence at the end of treatment. Secondary outcomes included cigarette smoking rate and post-quit nicotine deprivation symptoms (e.g., negative affect, withdrawal).
In this interim study analysis, end of treatment (EOT) quit rates did not differ between treatment arms (42% for placebo vs. 34% for modafinil; OR = 0.67 [0.34 – 1.31], p = .24). Further, from the target quit date to EOT, the daily smoking rate was 44% higher among non-abstainers in the modafinil arm, compared to non-abstainers in the placebo arm (IRR = 1.44, CI95 = 1.09–1.89, p < .01). Modafinil-treated participants also reported greater increases in negative affect and withdrawal symptoms, vs. participants randomized to placebo (ps < .05).
These data do not support the use of modafinil for the treatment of nicotine dependence and, as a consequence, this trial was discontinued. Cigarette smoking should be considered when modafinil is prescribed, particularly among those with psychiatric conditions that have high comorbidity with nicotine dependence.
PMCID: PMC2610628  PMID: 18541389
nicotine dependence; smoking cessation; addiction; modafinil
16.  Successful weight loss maintenance in relation to method of weight loss 
Obesity (Silver Spring, Md.)  2008;16(11):2456-2461.
This study examined the relation between method of weight loss and long-term maintenance among successful weight losers enrolled in a weight loss maintenance trial. Participants were 186 adults (mean age=51.6 ± 10.7 years, mean BMI=28.6 ± 4.7 kg/m2) enrolled in the STOP Regain trial who had lost at least 10% of their body weight in the prior two years using a very low calorie diet (VLCD; n=24), commercial program (n=95), or self-guided approach (n=67). Participants were randomized to a weight maintenance intervention delivered face-to-face or over the internet or to a newsletter control condition, and followed for 18 months. At study entry, individuals who had used a VLCD had achieved a weight loss of 24% of their maximum weight within the last two years compared to 17% achieved by those who had used a commercial program or self-guided approach (p<.001). However, individuals who had used a VLCD regained significantly more weight than the other two groups and by six months, there were no significant differences in overall percent weight loss (i.e., initial weight loss and maintenance) between VLCD, commercial, and self-guided methods. In contrast, individuals who had used a self-guided approach maintained their weight losses from baseline through 18 months. The large initial weight losses achieved by individuals who had used a VLCD were not maintained over time, while individuals who had used a self-guided approach maintained their initial weight losses with the greatest success. The generalizability of these findings is limited by the sizeable weight losses achieved by study participants.
PMCID: PMC2666007  PMID: 18719680
weight maintenance; weight regain; diet

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