Mary B. Roberts

Efficacy of an individualized, motivationally-tailored physical activity intervention

This study compared the efficacy of two low-cost interventions for physical activity adoption. Sedentary (N=194) adults recruited through newspaper advertisements were randomized to receive either a motivationally-matched, individually-tailored intervention (IT) or a standard self-help intervention (ST). Assessments and interventions were delivered by repeated mailings at baseline, one, three, and six months. Participants were assessed regarding current physical activity behavior, motivational readiness to adopt regular physical activity, and psychological constructs associated with physical activity participation (e.g. self-efficacy, decisional balance). Repeated measures analyses of variance (ANOVAs) revealed significant increases in physical activity participation between baseline and six months for both groups with a significantly greater increase among IT participants. The IT group outperformed the ST group on all primary outcome measures: (a) minutes of physical activity per week, (b) reaching Centers for Disease Control and American College of Sports Medicine (CDC/ACSM) recommended minimum physical activity criteria, and (c) achieving the Action stage of motivational readiness for physical activity adoption. Both groups showed significant improvement between baseline and six months on the psychological constructs associated with physical activity adoption (e.g. self-efficacy), with no significant differences observed between the treatment groups. Utilizing computer expert systems and self-help manuals to provide individually-tailored, motivationally-matched interventions appears to be an effective, low-cost approach for enhancing physical activity participation in the community.

Effect of Eritoran, an Antagonist of MD2-TLR4, on Mortality in Patients With Severe Sepsis: The ACCESS Randomized Trial

IMPORTANCE Eritoran is a synthetic lipid A antagonist that blocks lipopolysaccharide (LPS) from binding at the cell surface MD2-TLR4 receptor. LPS is a major component of the outer membrane of gram-negative bacteria and is a potent activator of the acute inflammatory response. OBJECTIVE To determine if eritoran, a TLR4 antagonist, would significantly reduce sepsis-induced mortality. DESIGN, SETTING, AND PARTICIPANTS We performed a randomized, double-blind, placebo-controlled, multinational phase 3 trial in 197 intensive care units. Patients were enrolled from June 2006 to September 2010 and final follow-up was completed in September 2011. INTERVENTIONS Patients with severe sepsis (n = 1961) were randomized and treated within 12 hours of onset of first organ dysfunction in a 2:1 ratio with a 6-day course of either eritoran tetrasodium (105 mg total) or placebo, with n = 1304 and n = 657 patients, respectively. MAIN OUTCOME MEASURES The primary end point was 28-day all-cause mortality. The secondary end points were all-cause mortality at 3, 6, and 12 months after beginning treatment. RESULTS Baseline characteristics of the 2 study groups were similar. In the modified intent-to-treat analysis (randomized patients who received at least 1 dose) there was no significant difference in the primary end point of 28-day all-cause mortality with 28.1% (366/1304) in the eritoran group vs 26.9% (177/657) in the placebo group (P = .59; hazard ratio, 1.05; 95% CI, 0.88-1.26; difference in mortality rate, -1.1; 95% CI, -5.3 to 3.1) or in the key secondary end point of 1-year all-cause mortality with 44.1% (290/657) in the eritoran group vs 43.3% (565/1304) in the placebo group, Kaplan-Meier analysis of time to death by 1 year, P = .79 (hazard ratio, 0.98; 0.85-1.13). No significant differences were observed in any of the prespecified subgroups. Adverse events, including secondary infection rates, did not differ between study groups. CONCLUSIONS AND RELEVANCE Among patients with severe sepsis, the use of eritoran, compared with placebo, did not result in reduced 28-day mortality. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00334828.

Evaluation of motivationally tailored vs. Standard self-help physical activity interventions at the workplace

Purpose. This study compares the efficacy of a self-help intervention tailored to the individuals stage of motivational readiness for exercise adoption with a standard self-help exercise promotion intervention. Design. Interventions were delivered at baseline and 1 month; assessments were collected at baseline and 3 months. Setting. Eleven worksites participating in the Working Healthy Research Trial. Subjects. Participants (n = 1559) were a subsample of employees at participating worksites, individually randomized to one of two treatment conditions. Intervention. Printed self-help exercise promotion materials either (1) matched to the individuals stage of motivational readiness for exercise adoption (motivationally tailored), or (2) standard materials (standard). Measures. Measures of stage of motivational readiness for exercise and items from the 7-Day Physical Activity Recall. Results. Among intervention completers (n = 903), chi-square analyses showed that, compared to the standard intervention, those receiving the motivationally tailored intervention were significantly more likely to show increases (37% vs. 27%) and less likely to show either no change (52% vs. 58%) or regression (11% vs. 15%) in stage of motivational readiness. Multivariate analyses of variance showed that changes in stage of motivational readiness were significantly associated with changes in self-reported time spent in exercise. Conclusions. This is the first prospective, randomized, controlled trial demonstrating the efficacy of a brief motivationally tailored intervention compared to a standard self-help intervention for exercise adoption. These findings appear to support treatment approaches that tailor interventions to the individuals stage of motivational readiness for exercise adoption.

Value of a supervised exercise program for the therapy of arterial claudication.

PURPOSE This study was performed to test the effectiveness of a formal supervised exercise program against a home-based exercise program for both walking ability and quality of life endpoints. METHODS Patients with arterial claudication were randomized to either a 12-week supervised exercise program (SUPEX) with weekly lectures relating to peripheral vascular disease or to a home exercise group (HOMEX) who attended an identical lecture program and received weekly exercise instruction. The study population included 29 men and 26 women, with a mean age of 69.1 +/- 8.1 years. Forty-seven patients completed the 12-week program, 46 were available for testing at completion, and 38 for 6-month testing. Claudication pain time (CPT) and maximum walking time (MWT) on a progressive treadmill exercise test were assessed at baseline, program completion, and 6 months. The Medical Outcomes Study Short Form-36 (SF-36) was administered at these intervals to assess effects on quality of life. RESULTS Each group improved (p < 0.001) in both CPT and MWT at the completion of the 12-week program, which was sustained at the 6-month follow-up. Increase in HOMEX CPT from baseline (3.6 +/- 2.73 minutes) to 6-month follow-up (6.6 +/- 3.17 minutes) was less than for the SUPEX group (3.8 +/- 2.74 to 11.2 +/- 4.02 minutes, respectively); similar results were obtained for MWT. At both completion and 6 months, there was a significant intergroup difference for CPT and MWT (p < 0.004) favoring SUPEX. For both groups, measures of health perception based on the SF-36 demonstrated improvement (p < 0.002) in Physical Function Subscale, Bodily Pain Subscale, and Physical Composite Score. There were no between-group differences on the subsets of the SF-36 at the three assessment intervals. CONCLUSIONS Supervised exercise programs provide superior increased walking ability in the noninterventional therapy of arterial claudication, and both supervised and home based exercise therapy result in improved SF-36 functional measures. The lack of intergroup differences in these measures may be a result of the high degree of interaction with healthcare providers in the HOMEX group. Although a supervised program results in optimal walking benefits, a highly structured home-based program provides similar functional improvement and may be a satisfactory alternative for patients with lesser walking requirements.

Motivation to Modify Lifestyle Risk Behaviors in Women Treated for Breast Cancer

OBJECTIVE To determine motivators of health behaviors (relevant to risk for chronic disease and cancer recurrence) after a cancer diagnosis. PATIENTS AND METHODS Eighty-six women who had been treated for breast cancer (mean age, 54.8 years; median time since diagnosis, 23.5 months) participated in this cross-sectional study (1997-1998). Respondents completed a questionnaire assessing overweight or obesity status, dietary fat intake, energy expenditure, motivational readiness for exercise and weight loss, and variables associated with readiness for exercise adoption and weight loss. RESULTS Forty-six women (54%) were overweight or obese, and 47 women (55%) reported dietary fat intake of 30% or higher. Sixty-one women (72%) were in action/ maintenance stages for exercise adoption. A majority believed that diet and exercise can change the course of cancer. Overweight and obese women in the sample were more likely to be in early stages of motivational readiness for weight loss, and they reported significantly lower exercise self-efficacy and lower eating self-efficacy than their nonoverweight peers. However, they endorsed more benefits associated with weight loss than the nonoverweight subgroup. Thirty-three women (39%) reported both a low-fat diet and exercising at recommended levels. CONCLUSIONS Only a minority of respondents reported consuming a diet low in fat and exercising at recommended levels, which suggests a need to improve both diet and exercise behaviors among women treated for breast cancer. Overweight and obese women reported low self-efficacy for exercise and eating, suggesting that interventions should focus on increasing self-efficacy for behavior change.

Forced Smoking Abstinence Not Enough for Smoking Cessation

IMPORTANCE Millions of Americans are forced to quit smoking as they enter tobacco-free prisons and jails, but most return to smoking within days of release. Interventions are needed to sustain tobacco abstinence after release from incarceration. OBJECTIVE To evaluate the extent to which the WISE intervention (Working Inside for Smoking Elimination), based on motivational interviewing (MI) and cognitive behavioral therapy (CBT), decreases relapse to smoking after release from a smoke-free prison. DESIGN Participants were recruited approximately 8 weeks prior to their release from a smoke-free prison and randomized to 6 weekly sessions of either education videos (control) or the WISE intervention. SETTING A tobacco-free prison in the United States. PARTICIPANTS A total of 262 inmates (35% female). MAIN OUTCOME MEASURE Continued smoking abstinence was defined as 7-day point-prevalence abstinence validated by urine cotinine measurement. RESULTS At the 3-week follow-up, 25% of participants in the WISE intervention (31 of 122) and 7% of the control participants (9 of 125) continued to be tobacco abstinent (odds ratio [OR], 4.4; 95% CI, 2.0-9.7). In addition to the intervention, Hispanic ethnicity, a plan to remain abstinent, and being incarcerated for more than 6 months were all associated with increased likelihood of remaining abstinent. In the logistic regression analysis, participants randomized to the WISE intervention were 6.6 times more likely to remain tobacco abstinent at the 3-week follow up than those randomized to the control condition (95% CI, 2.5-17.0). Nonsmokers at the 3-week follow-up had an additional follow-up 3 months after release, and overall 12% of the participants in the WISE intervention (14 of 122) and 2% of the control participants (3 of 125) were tobacco free at 3 months, as confirmed by urine cotinine measurement (OR, 5.3; 95% CI, 1.4-23.8). CONCLUSIONS AND RELEVANCE Forced tobacco abstinence alone during incarceration has little impact on postrelease smoking status. A behavioral intervention provided prior to release greatly improves cotinine-confirmed smoking cessation in the community. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01122589.

Relationship between Mediterranean Diet Score and atherothrombotic risk: Findings from the Third National Health and Nutrition Examination Survey (NHANES III), 1988-1994

BACKGROUND Mediterranean diet has been promoted as the preferred dietary model for cardiovascular disease prevention in the United States. OBJECTIVE We sought to evaluate the degree to which the Mediterranean diet is associated with reduced levels of atherothrombotic biomarkers in a population-based sample in the U.S. DESIGN Data from 13,197 adults between the ages of 18 and 90 were collected and atherothrombotic risk factors assessed as part of the NHANES III, 1988-1994. Adherence to the Mediterranean diet was evaluated using food frequency questionnaires, supplemented by the 24-h dietary recall data, to develop Mediterranean Diet Scores (MedDietScore) that were analyzed in tertiles. The cross-sectional relationship of MedDietScore to atherothrombotic factors were analyzed using multiple variable regression analysis adjusted for complex sampling design using SUDAAN. RESULTS The components of the Mediterranean diet and the dietary patterns associations with atherothrombotic risk factors differed by age and gender. For men <45 years of age as MedDietScore increased: total cholesterol/HDL cholesterol (TC/HDL) ratio (p=0.0390), serum insulin (p=0.0414), and white blood cell (WBC) (p=0.0246) decreased. For men>or=45 years as MedDietScore increased: TC/HDL ratio (p=0.0008), Hemoglobin A1c (HgbA1c) (p=0.0001), HOMA index (p=0.0486), C-reactive protein (p=0.0034), fibrinogen (p=0.0028) decreased and HDL cholesterol (HDL-c) levels (p<0.0001) increased. For pre-menopausal women, as MedDietScore increased: TC/HDL ratio (p<0.0001), non-HDL cholesterol (p=0.0012), apolipoprotein B (p=0.0112), HgbA1c (p=0.0001), decreased and HDL-c levels (p<0.0001) increased. For post-menopausal women, as MedDietScore increased: TC/HDL ratio (p=0.0005), Triglycerides (p<0.0001), serum insulin (p=0.0062), HOMA index (p=0.0063) and Homocysteine (Hcy) (0.0046) levels decreased and HDL-c levels (p=0.0005) increased. CONCLUSIONS Mediterranean diet appears to be associated with selective measures of cardioprotective lipid profiles, glucose metabolism, and inflammation and coagulation levels.

Effect of Language on Colorectal Cancer Screening Among Latinos and Non-Latinos

Background: Language barriers among some Latinos may contribute to the lower rates of colorectal cancer (CRC) screening between Latinos and non-Latino Whites. The purpose of this study was to examine the relationship between language and receipt of CRC screening tests among Latinos and non-Latinos using a geographically diverse, population-based sample of adults. Methods: Cross-sectional analysis of the Behavioral Risk Factor Surveillance System (BRFSS) survey. Analysis included adults age 50 years and older, who completed the 2006 BRFSS in a state that recorded data from English- and Spanish-speaking participants. Results: The primary outcome measure was receipt of colorectal screening tests (fecal occult blood testing within prior 12 months and/or lower endoscopy within 10 years). Of the 99,895 respondents included in the study populations, 33% of Latinos responding-in-Spanish reported having had CRC testing, whereas 51% of Latinos responding-in-English and 62% of English-speaking non-Latinos reported test receipt. In multivariable analysis, compared with non-Latinos, Latinos responding-in-English were 16% less likely to have received CRC testing [odds ratio (OR), 0.84; 95% confidence interval (95% CI), 0.73-0.98], and Latinos responding-in-Spanish were 43% less likely to have received CRC testing (OR, 0.57; 95% CI, 0.44-0.74). Additionally, compared with Latinos responding-in-English, Latinos responding-in-Spanish were 36% less likely to have received CRC testing (OR, 0.64; 95% CI, 0.48-0.84). Conclusion: Latinos responding to the 2006 BRFSS survey in Spanish had a significantly lower likelihood of receiving CRC screening tests compared with non-Latinos and to Latinos responding-in-English. Based on this analysis, Spanish language use is negatively associated with CRC screening and may contribute to disparities in CRC screening. (Cancer Epidemiol Biomarkers Prev 2008;17(8):2169–73)

Predictors of quitting and dropout among women in a clinic-based smoking cessation program

Most cessation studies assume that dropouts are smokers. Instead, the authors analyzed these outcomes separately using multinomial regression to model the relative risk of quitting versus continued smoking and dropping out. Female (N = 281) smokers were randomly assigned to a 12-week smoking cessation program plus either a 3-times-per-week exercise program or a contact control wellness program. Higher body mass index and longer prior quit attempts predicted cessation. Self-efficacy was associated with a lower likelihood of dropout. Greater nicotine dependence and lower education predicted continued smoking or dropout versus quitting among exercisers. Patterns of smoking, dropping out, and quitting between Weeks 5 and 12 were different between exercisers and controls. Dropouts should be considered as a separate category from smokers.

Weight control smoking among sedentary women

This study examined characteristics associated with weight control smoking among 281 sedentary women enrolled in a smoking cessation trial. A series of regression models were developed to identify predictors of weight control smoking as measured by the Smoking Situations Questionnaire. Predictor variables included demographic variables, dietary intake, weight gain following previous quit attempts, dietary restraint, self-efficacy for weight management, smoking behavior, exercise behavior, negative affect and psychological constructs relevant to smoking cessation, and exercise adoption. In the final predictor model, anticipation of weight gain in the current quit attempt, higher dietary restraint, younger age, greater Fagerstrom scores, greater number of pounds gained in previous quit attempts, and lower levels of self-efficacy to manage weight in negative affect situations were associated with smoking for weight control. Treatment implications for women who smoke for weight control reasons are discussed.