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1.  All-Cause, Cardiovascular, and Cancer Mortality Rates in Postmenopausal White, Black, Hispanic, and Asian Women With and Without Diabetes in the United States 
American Journal of Epidemiology  2013;178(10):1533-1541.
Using data from the Women's Health Initiative (1993–2009; n = 158,833 participants, of whom 84.1% were white, 9.2% were black, 4.1% were Hispanic, and 2.6% were Asian), we compared all-cause, cardiovascular, and cancer mortality rates in white, black, Hispanic, and Asian postmenopausal women with and without diabetes. Cox proportional hazard models were used for the comparison from which hazard ratios and 95% confidence intervals were computed. Within each racial/ethnic subgroup, women with diabetes had an approximately 2–3 times higher risk of all-cause, cardiovascular, and cancer mortality than did those without diabetes. However, the hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups. Population attributable risk percentages (PARPs) take into account both the prevalence of diabetes and hazard ratios. For all-cause mortality, whites had the lowest PARP (11.1, 95% confidence interval (CI): 10.1, 12.1), followed by Asians (12.9, 95% CI: 4.7, 20.9), blacks (19.4, 95% CI: 15.0, 23.7), and Hispanics (23.2, 95% CI: 14.8, 31.2). To our knowledge, the present study is the first to show that hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups when stratified by diabetes status. Because of the “amplifying” effect of diabetes prevalence, efforts to reduce racial/ethnic disparities in the rate of death from diabetes should focus on prevention of diabetes.
PMCID: PMC3888272  PMID: 24045960
diabetes; health disparities; menopause; mortality; obesity; women's health
2.  Phone-Delivered Mindfulness Training for Patients with Implantable Cardioverter Defibrillators: Results of a Pilot Randomized Controlled Trial 
The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators.
To determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety.
Clinically stable outpatients were randomized to a mindfulness intervention (8 weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness; and multivariate linear regression to estimate the intervention effect on pre-post intervention changes in these variables.
We enrolled 45 patients (23 mindfulness, 22 control; age 43–83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = .04) and anxiety (beta = − 1.15; p = .059) improved in the mindfulness group.
Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients.
PMCID: PMC3758416  PMID: 23605175
mindfulness; anxiety; implantable cardioverter defibrillators; phone-delivery
3.  Underreporting of energy intake and associated factors in a Latino population at risk of developing type 2 diabetes 
The objective of this study is to examine the extent of underreporting of total caloric intake and associated factors in a low-income, low-literacy, predominantly Caribbean Latino community in Lawrence, Massachusetts. Two hundred fifteen Latinos participated in a diabetes prevention study, with eligibility included a ≥30% risk of developing diabetes in 7.5 years. Dietary self-reported energy intake (EI) was assessed using three randomly selected days of 24-hour diet recalls. Basal metabolic rate (BMRest) was estimated using the Mifflin-St Jeor equation. Underreporting was determined by computing a ratio of EI to BMRest, with a ratio of 1.55 expected for sedentary populations. Linear regression analyses were used to identify factors associated with underreporting (EI:BMRest ratio). The population was predominately female (77%), middle-aged [mean =52 years; standard deviation (SD)=11], obese (78% had a BMI≥30 kg/m2); low-literate (62% < high school education), unemployed (57% reported no job), married or living with partner (52%), and some had a family history of diabetes (37% had siblings with diabetes). Reported total daily EI was 1540 kcal (SD=599), whereas estimated BMR was 1495.7 kcal/day (SD=245.1). When multiplied by an activity factor (1.20 for sedentariness), expected caloric intake was 1794 (SD=294.0), indicating underreporting by an average of 254 Kcal/day. Mean EI/BMRest was 1.03 (SD=0.37), and was lower for participants with higher BMI, siblings with diabetes, sedentary lifestyle, and the unemployed. EI underreporting is prevalent in this low-income, low- literacy Caribbean Latino population. Future studies are needed to develop dietary assessment measures that minimize underreporting in this population.
PMCID: PMC4017735  PMID: 18502234
4.  Randomized controlled trial of behavioral treatment for comorbid obesity and depression in women: the Be Active Trial 
International journal of obesity (2005)  2013;37(11):10.1038/ijo.2013.25.
Depression is associated with increased risk for obesity and worse weight loss treatment outcomes. The purpose of the present study was to test the hypothesis that delivering evidence-based behavior therapy for depression prior to a lifestyle weight loss intervention improves both weight loss and depression.
In a randomized controlled trial, obese women with major depressive disorder (N=161, mean age=45.9 [SD: 10.8] years) were randomized to brief behavior therapy for depression treatment followed by a lifestyle intervention (BA) or a lifestyle intervention only (LI). Follow-up occurred at 6- and 12-months. Main outcome measures included weight loss and depression symptoms.
Intention-to-treat analyses revealed both conditions lost significant weight, but no differences between conditions in weight change at 6-months (BA= −3.0%, SE= − 0.65%; LI=−3.7%, SE = 0.63%; p = 0.48) or 12-months (BA= −2.6%, SE= 0.77%; LI= −3.1%, SE=0.74%; p= 0.72). However, the BA condition evidenced significantly greater improvement in Beck Depression Inventory-II scores relative to the LI condition at both 6-months (BA mean change= −12.5, SD= 0.85; LI mean change= −9.2, SD=0.80, p= 0.005) and 12-months (BA mean change= −-12.6, SD= 0.97; LI mean change= −9.9, SD= 0.93; p = 0.045). Participants who experienced depression remission by 6-months (61.2%) lost greater weight (mean = −4.31%; SE=0.052) than those who did not (39.7%; mean= −2.47%, SE=0.53; p=.001).
Adding behavior therapy to a lifestyle intervention results in greater depression remission but does not improve weight loss within one year. Improvement in depression is associated with greater weight loss.
PMCID: PMC3675166  PMID: 23459323
Obesity; depression; lifestyle intervention; behavior therapy
5.  Severity of Depressive Symptoms and Accuracy of Dietary Reporting among Obese Women with Major Depressive Disorder Seeking Weight Loss Treatment 
PLoS ONE  2014;9(2):e90361.
An elevation in symptoms of depression has previously been associated with greater accuracy of reported dietary intake, however this association has not been investigated among individuals with a diagnosis of major depressive disorder. The purpose of this study was to investigate reporting accuracy of dietary intake among a group of women with major depressive disorder in order to determine if reporting accuracy is similarly associated with depressive symptoms among depressed women. Reporting accuracy of dietary intake was calculated based on three 24-hour phone-delivered dietary recalls from the baseline phase of a randomized trial of weight loss treatment for 161 obese women with major depressive disorder. Regression models indicated that higher severity of depressive symptoms was associated with greater reporting accuracy, even when controlling for other factors traditionally associated with reporting accuracy (coefficient  =  0.01 95% CI = 0.01 – 0.02). Seventeen percent of the sample was classified as low energy reporters. Reporting accuracy of dietary intake increases along with depressive symptoms, even among individuals with major depressive disorder. These results suggest that any study investigating associations between diet quality and depression should also include an index of reporting accuracy of dietary intake as accuracy varies with the severity of depressive symptoms.
PMCID: PMC3938682  PMID: 24587338
6.  Can attention control conditions have detrimental effects in behavioral medicine randomized trials? 
Psychosomatic medicine  2012;75(2):137-143.
Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental.
Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet.
At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes.
The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed.
PMCID: PMC3570637  PMID: 23197844
Attention control; control groups; placebo; behavioral interventions; randomized controlled trials
7.  Determinants of Racial/Ethnic Disparities in Incidence of Diabetes in Postmenopausal Women in the U.S. 
Diabetes Care  2012;35(11):2226-2234.
To examine determinants of racial/ethnic differences in diabetes incidence among postmenopausal women participating in the Women’s Health Initiative.
Data on race/ethnicity, baseline diabetes prevalence, and incident diabetes were obtained from 158,833 women recruited from 1993–1998 and followed through August 2009. The relationship between race/ethnicity, other potential risk factors, and the risk of incident diabetes was estimated using Cox proportional hazards models from which hazard ratios (HRs) and 95% CIs were computed.
Participants were aged 63 years on average at baseline. The racial/ethnic distribution was 84.1% non-Hispanic white, 9.2% non-Hispanic black, 4.1% Hispanic, and 2.6% Asian. After an average of 10.4 years of follow-up, compared with whites and adjusting for potential confounders, the HRs for incident diabetes were 1.55 for blacks (95% CI 1.47–1.63), 1.67 for Hispanics (1.54–1.81), and 1.86 for Asians (1.68–2.06). Whites, blacks, and Hispanics with all factors (i.e., weight, physical activity, dietary quality, and smoking) in the low-risk category had 60, 69, and 63% lower risk for incident diabetes. Although contributions of different risk factors varied slightly by race/ethnicity, most findings were similar across groups, and women who had both a healthy weight and were in the highest tertile of physical activity had less than one-third the risk of diabetes compared with obese and inactive women.
Despite large racial/ethnic differences in diabetes incidence, most variability could be attributed to lifestyle factors. Our findings show that the majority of diabetes cases are preventable, and risk reduction strategies can be effectively applied to all racial/ethnic groups.
PMCID: PMC3476929  PMID: 22833490
8.  Prospective Analysis of Association Between Use of Statins or Other Lipid-Lowering Agents and Colorectal Cancer Risk 
Annals of epidemiology  2011;22(1):17-27.
To determine whether 3-hydroxy-3-methylglutaryl coenzyme A inhibitors (statins) are associated with a decreased risk of colorectal cancer.
The population included 159,219 postmenopausal women enrolled in the Women’s Health Initiative in which 2000 pathologically confirmed cases of colorectal cancer were identified during an average of 10.7 (S.D. 2.9) years. Information on statins was collected at baseline and years 1, 3, 6, and 9. Self- and interviewer-administered questionnaires were used to collect information on other risk factors. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated by the use of Cox proportional hazards regression to evaluate the relationship between statin use and risk. Statistical tests were two-sided.
Statins were used by 12,030 (7.6%) women at baseline. The annualized colorectal cancer rate was 0.13% among users and 0.12% among nonusers. The multivariable adjusted HR for users versus nonusers was 0.99 (95% confidence interval [CI], 0.83–1.20, p=.95), and 0.79 (95% CI, 0.56–1.11) for users of ≥3 years. In the multivariable adjusted time-dependent model, the HR for lovastatin was 0.62 (95% CI, 0.39–0.99). There was no effect of tumor location, stage or grade.
There was a reduction in colorectal cancer risk associated with lovastatin and a non-significant association with longer duration of use.
PMCID: PMC3804112  PMID: 22056480
Colorectal Cancer; Statins; Cancer Risk; Cohort Study
9.  Prospective Analysis of Association Between Use of Statins and Melanoma Risk in the Women’s Health Initiative 
Cancer  2012;118(20):5124-5131.
Melanoma is the most lethal form of skin cancer, with an estimated 68,130 new cases and 8700 deaths in the United States in 2010. The increasing incidence and high death rate associated with metastatic disease support the need to focus on prevention. The authors used data from the Women’s Health Initiative (WHI) to assess whether 3-hydroxy-3 methylglutaryl coenzyme A inhibitors (statins) are associated with a decreased risk of melanoma.
The study population consisted of 119,726 postmenopausal white women, in which 1099 cases of malignant melanoma were identified over an average (istandard deviation) of 11.6 ±3.2 years. All diagnoses were confirmed by medical record review and pathology reports. Information on statin use was collected at baseline and during follow-up. Self-administered and interview-administered questionnaires were used to collect information on other risk factors. Cox proportional hazards regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). Analyses investigated the association of any statin use, type, potency, lipophilic status, and duration of use with melanoma.
Statins were used by 8824 women (7.4%) at baseline. The annualized rate of melanoma was 0.09% among statin users and 0.09% among nonusers The multivariable adjusted HR for statin users compared with nonusers was 1.14 (95% CI, 0.91–1.43). There were no significant differences in risk based on statin type, potency, category, duration, or in time-dependent models.
There was no significant association between statin use and melanoma risk among postmenopausal women in the WHI.
PMCID: PMC3799780  PMID: 22434400
statins; melanoma; cohort study; epidemiology; cancer risk
10.  Spiritual well-being may buffer psychological distress in patients with implantable cardioverter defibrillators (ICD) 
Psychological distress is common in patients with implantable cardioverter defibrillators (ICDs) and has been associated with a worse prognosis. The authors examined whether spiritual wellbeing is associated with reduced psychological distress in patients with ICDs. The Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SWB) questionnare and the Hospital Anxiety and Depression Scale (HADS) were used to measure spiritual wellbeing and overall psychological distress. Multivariate linear regression was used to explore the relationship between these variables.
The study sample included 46 ICD outpatients (32 M, 14 F; age range 43–83). An inverse association between HADS and FACIT-SWB scores was found, persisting after adjustment for demographics, anxiety/depression, medications, therapist support, and functional status (F = 0.001; β= −0.31, CI: −0.44, −0.19). In conclusion, spiritual wellbeing was independently associated with lower psychological distress in ICD outpatients. Spiritual wellbeing could act as a protective factor against psychological distress in these high-risk patients.
PMCID: PMC3462453  PMID: 23050210
prevention; spirituality; cardioverter defibrillators
11.  Vitamin D Supplementation and Depression in the Women’s Health Initiative Calcium and Vitamin D Trial 
While observational studies have suggested that vitamin D deficiency increases risk of depression, few clinical trials have tested whether vitamin D supplementation affects the occurrence of depression symptoms. The authors evaluated the impact of daily supplementation with 400 IU of vitamin D3 combined with 1,000 mg of elemental calcium on measures of depression in a randomized, double-blinded US trial comprising 36,282 postmenopausal women. The Burnam scale and current use of antidepressant medication were used to assess depressive symptoms at randomization (1995–2000). Two years later, women again reported on their antidepressant use, and 2,263 completed a second Burnam scale. After 2 years, women randomized to receive vitamin D and calcium had an odds ratio for experiencing depressive symptoms (Burnam score ≥0.06) of 1.16 (95% confidence interval: 0.86, 1.56) compared with women in the placebo group. Supplementation was not associated with antidepressant use (odds ratio = 1.01, 95% confidence interval: 0.92, 1.12) or continuous depressive symptom score. Results stratified by baseline vitamin D and calcium intake, solar irradiance, and other factors were similar. The findings do not support a relation between supplementation with 400 IU/day of vitamin D3 along with calcium and depression in older women. Additional trials testing higher doses of vitamin D are needed to determine whether this nutrient may help prevent or treat depression.
PMCID: PMC3385159  PMID: 22573431
antidepressive agents; calcium; clinical trial; depression; dietary supplements; postmenopause; vitamin D; women
12.  Depression severity, diet quality, and physical activity in women with obesity and depression 
Major depressive disorder (MDD) is prevalent in clinical weight loss settings and predicts poor weight loss outcomes. It is unknown whether the severity of depressive symptoms among those with MDD is associated with diet quality or physical activity levels. This knowledge is important for improving weight loss treatment for these patients. It was hypothesized that more severe depression is associated with poorer diet quality and lower physical activity levels among individuals with obesity and MDD. Participants were 161 women with current MDD and obesity enrolled in the baseline phase of a weight loss trial between 2007 and 2010. Depression severity was measured with the Beck Depression Inventory II. The Alternate Healthy Eating Index (AHEI) was applied to data from three 24-hour diet recalls to capture overall diet quality. Daily metabolic equivalents expended per day (MET-hrs/d) were calculated from three 24-hour physical activity recalls. Greater depression severity was associated with poorer overall diet quality (estimate=−.26, SE=.11, p=.02), but not with physical activity (estimate=.07, SE=.05, p=.18), in linear regression models controlling for income, education, depression-related appetite change, binge eating disorder, and other potential confounds. Associations with diet quality were primarily driven by greater intake of sugar (r=.20, p<.01), saturated fat (r=.21, p<.01), and sodium (r=.22, p<.01). More severe depression was associated with poorer overall diet quality, but not physical activity, among treatment-seeking women with MDD and obesity. Future studies should identify mechanisms linking depression to diet quality, and determine whether diet quality improves with depression treatment.
PMCID: PMC3378978  PMID: 22709773
Diet quality; Depression; Obesity; AHEI; Physical activity
13.  Dietary Intervention Targeting Increased Fiber Consumption for Metabolic Syndrome 
PMCID: PMC3433761  PMID: 22709766
Diet; nutrition; fiber; metabolic syndrome
14.  Characteristics of Dispositional Mindfulness in Patients with Severe Cardiac Disease 
The characteristics of dispositional mindfulness have rarely been explored in unhealthy populations. We sought to evaluate its association(s) with psychological morbidity and disease severity in 30 outpatients with implantable cardioverter defibrillators naïve to mindfulness training. We used the Five Facets of Mindfulness and the Hospital Anxiety and Depression Scale to measure dispositional mindfulness and anxiety/depression, respectively. Associations were estimated using linear regression models. Higher dispositional mindfulness was observed in patients with lower anxiety scores (β = − 1.10, CI: −1.71, −0.49) and no history of depression (β = − 7.95; CI: −14.31, −1.6) by univariate analysis. No associations were observed with disease severity or other covariates. In conclusion, psychological well-being and psychological morbidity, and not disease severity, appear to be associated with dispositional mindfulness in patients with implantable cardioverter defibrillators. Further research is needed to confirm these findings.
PMCID: PMC3221306  PMID: 22116792
dispositional mindfulness; cardiovascular disease; implantable cardioverter defibrillators; mindfulness training
15.  Constipation and Risk of Cardiovascular Disease among Post-Menopausal Women 
The American journal of medicine  2011;124(8):714-723.
Constipation is common in Western societies, accounting for 2.5 million-physician visits/year in the US. Since many factors predisposing to constipation are also risk factors for cardiovascular disease, we hypothesized that constipation may be associated with increased risk of cardiovascular events.
We conducted a secondary analysis in 93,676 women enrolled in the observational arm of the Women’s Health Initiative. Constipation was evaluated at baseline by a self-administered questionnaire. Estimates of the risk of cardiovascular events (cumulative endpoint including mortality from coronary heart disease, myocardial infarction, angina, coronary revascularization, stroke and transient ischemic attack) were derived from Cox proportional hazards models adjusted for demographics, risk factors and other clinical variables (median follow-up: 6.9 years).
The analysis included 73,047 women. Constipation was associated with increased age, African American and Hispanic descent, smoking, diabetes, high cholesterol, family history of myocardial infarction, hypertension, obesity, lower physical activity levels, lower fiber intake, and depression. Women with moderate and severe constipation experienced more cardiovascular events (14.2 and 19.1 events/1000 person-years, respectively) compared to women with no constipation (9.6/1000 person-years). After adjustment for demographics, risk factors, dietary factors, medications, frailty and other psychological variables, constipation was no longer associated with an increased risk of cardiovascular events except for the severe constipation group, which had a 23% higher risk of cardiovascular events.
In postmenopausal women, constipation is a marker for cardiovascular risk factors and increased cardiovascular risk. Since constipation is easily assessed, it may be a helpful tool to identify women with increased cardiovascular risk.
PMCID: PMC3144272  PMID: 21663887
cardiovascular disease; prevention; women’s health; risk factors
16.  Quality of life and baseline characteristics associated with depressive symptoms among patients with heart disease 
Clinical Epidemiology  2012;4:181-186.
We sought to examine factors associated with depressive symptoms among patients with heart disease. Data from 197 patients admitted for coronary artery disease were examined using multivariate predictive models. Women and unmarried patients were more likely to report depressive symptoms. In multivariate models, we observed that depressive symptoms were associated with the level of tangible social (but not emotional) support, bodily pain, and vitality, but not the number of comorbidities, gender, or marital status.
PMCID: PMC3410688  PMID: 22866019
heart disease; quality of life; depression
17.  Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder 
The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression.
Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial.
A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression.
Trial registration
PMCID: PMC3134367  PMID: 21765864
The American journal of medicine  2011;124(6):557-565.
Peripheral arterial disease patients are less likely than other high-risk patients to achieve ideal low density lipoprotein cholesterol (LDL-cholesterol) levels. This randomized controlled trial assessed whether a telephone counseling intervention, designed to help peripheral arterial disease patients request more intensive cholesterol lowering therapy from their physician, achieves lower LDL-cholesterol levels than two control conditions.
355 peripheral arterial disease participants with baseline LDL-cholesterol ≥ 70 mg/dl were enrolled. The primary outcome was change in LDL-cholesterol level at twelve-month follow-up. There were three parallel arms: telephone counseling intervention, attention control condition, and usual care. The intervention consisted of patient-centered counseling, delivered every six weeks, encouraging participants to request increases in cholesterol-lowering therapy from their physician. The attention control condition consisted of telephone calls every six weeks providing information only. The usual care condition participated in baseline and follow-up testing.
At 12-month follow-up, participants in the intervention improved their LDL-cholesterol level, compared to those in attention control (−18.4 mg/dl vs. −6.8 mg/dl, p= 0.010) but not compared to those in usual care (−18.4 mg/dl vs. −11.1 mg/dl, p= 0.208). Intervention participants were more likely to start a cholesterol-lowering medication or increase their cholesterol-lowering medication dose than those in the attention control (54% vs. 18%, p=0.001) and usual care (54% vs. 31%, P<0.001) conditions.
Telephone counseling that helped peripheral arterial disease patients request more intensive cholesterol-lowering therapy from their physician achieved greater LDL-cholesterol declines than an attention control arm that provided health information alone.
PMCID: PMC3225919  PMID: 21605733
Intermittent claudication; secondary prevention; peripheral arterial disease
19.  Randomized Trial of a Literacy-Sensitive, Culturally Tailored Diabetes Self-Management Intervention for Low-Income Latinos 
Diabetes Care  2011;34(4):838-844.
To test whether a theory-based, literacy, and culturally tailored self-management intervention, Latinos en Control, improves glycemic control among low-income Latinos with type 2 diabetes.
A total of 252 patients recruited from community health centers were randomized to the Latinos en Control intervention or to usual care. The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge, attitudes, and self-management behaviors. The primary outcome was HbA1c. Secondary outcomes included diet, physical activity, blood glucose self-monitoring, diabetes knowledge and self-efficacy, and other physiological factors (e.g., lipids, blood pressure, and weight). Measures were collected at baseline and at 4- and 12-month follow-up. Change in outcomes over time between the groups and the association between HbA1c and possible mediators were estimated using mixed-effects models and an intention-to-treat approach.
A significant difference in HbA1c change between the groups was observed at 4 months (intervention −0.88 [−1.15 to −0.60] versus control −0.35 [−0.62 to 0.07], P < 0.01), although this difference decreased and lost statistical significance at 12 months (intervention −0.46 [−0.77 to −0.13] versus control −0.20 [−0.53 to 0.13], P = 0.293). The intervention resulted in significant change differences in diabetes knowledge at 12 months (P = 0.001), self-efficacy (P = 0.001), blood glucose self-monitoring (P = 0.02), and diet, including dietary quality (P = 0.01), kilocalories consumed (P < 0.001), percentage of fat (P = 0.003), and percentage of saturated fat (P = 0.04). These changes were in turn significantly associated with HbA1c change at 12 months.
Literacy-sensitive, culturally tailored interventions can improve diabetes control among low-income Latinos; however, strategies to sustain improvements are needed.
PMCID: PMC3064037  PMID: 21378213
20.  Design and Methods for a Pilot Study of a Phone-Delivered, Mindfulness-Based Intervention in Patients with Implantable Cardioverter Defibrillators 
Background. Meditation practices are associated with a reduction in adrenergic activity that may benefit patients with severe cardiac arrhythmias. This paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention (MBI) for treatment of anxiety in patients with implantable cardioverter defibrillators (ICDs). Design and Methods. Consecutive, clinically stable outpatients (n = 52) will be screened for study eligibility within a month of an ICD-related procedure or ICD shock and will be randomly assigned to MBI or to usual care. MBI patients will receive eight weekly individual phone sessions based on two mindfulness practices (awareness of breath and body scan) plus home practice with a CD for 20 minutes daily. Patients assigned to usual care will be offered the standard care planned by the hospital. Assessments will occur at baseline and at the completion of the intervention (between 9 and 12 weeks after randomization). The primary study outcome is feasibility; secondary outcomes include anxiety, mindfulness, and number of administered shocks during the intervention period. Conclusions. If proven feasible and effective, phone-delivered mindfulness-based interventions could improve psychological distress in ICD outpatients with serious cardiovascular conditions.
PMCID: PMC3320061  PMID: 22536294
21.  Spontaneous Coronary Artery Dissection during Cabergoline Therapy 
Texas Heart Institute Journal  2012;39(1):92-94.
Although spontaneous coronary artery dissection is a rare cause of acute coronary syndrome, it should be considered during the evaluation of patients who have chest pain. Coronary vasospasm can lead to spontaneous dissection. The dopamine agonist cabergoline is known to cause digital vasospasm. Herein, we report a case of spontaneous right coronary artery dissection in a 43-year-old woman who was taking cabergoline as therapy for prolactinoma. To our knowledge, this is the first report of an apparent relationship between cabergoline therapy and spontaneous coronary artery dissection. The possible association of cabergoline with coronary artery spasm and dissection should be considered in patients who present with chest pain while taking this medication.
PMCID: PMC3298899  PMID: 22412238
Acute coronary syndrome/diagnosis/etiology/therapy; cabergoline/adverse effects; coronary vasospasm/chemically induced; dopamine agonists/adverse effects; rupture, spontaneous/diagnosis/etiology; substance-related disorders/complications
22.  Perceived Quality of Care and Lifestyle Counseling among Patients with Heart Disease 
Clinical cardiology  2010;33(12):765-769.
To examine patient’s perceived quality of care and reported receipt of information on diet and exercise related to cardiovascular prevention.
Main Outcome Measures
Patients admitted with acute coronary syndromes or elective catheterization were eligible for enrollment. Baseline medical information was collected through medical record review. Patients completed surveys at the time of hospitalization which included items on perceived quality of care and whether they received information on diet and exercise as related to their heart from a healthcare provider. Perceived quality of care was grouped into 3 levels; poor to fair, good and very good to excellent.
Among the 182 cardiac patients who completed the survey, those who reported poor to fair quality of care were more likely to report that they received no advice regarding diet as compared to those who perceived their quality of care as good or very good to excellent (61%, 59% and 26%, respectively, p < 0.0001). A similar pattern was observed for exercise (71%, 74% and 36%, respectively, p < 0.0001).
Patients with low perceived quality of care were less likely to have discussed diet and exercise habits with healthcare providers. Improving receipt of lifestyle counseling warranted given the central role diet and exercise has in secondary prevention.
PMCID: PMC3058795  PMID: 21184561
Heart disease; cardiovascular prevention; education
23.  Patients and providers view gout differently: a qualitative study 
Chronic illness  2010;6(4):263-271.
We sought to examine patients’ and providers’ views on the treatment of gout to better understand why management is suboptimal.
In-depth telephone interviews were conducted with gout patients (n=26) who initiated treatment with a urate-lowering drug (ULD) in the prior 6 months and with providers who care for gout patients (n=15). The interviews were audiotaped and transcribed verbatim. Using qualitative methods, results were analyzed and themes were identified. Interviews focused on the acute management, chronic management, and prevention and improvement strategies.
Providers viewed the majority of patients as having excellent relief with nonsteroidal anti-inflammatories, colchicine and glucocorticoids while some patients felt these medications were ineffective. Providers felt most patients had a good understanding of the rationale for ULD therapy and that patients responded well. Some patients felt ULDs triggered, worsened or had no impact on their disease. Most providers thought medication adherence was relatively good. Some patients reported discontinuing medications. Discontinuations were largely purposeful and due to clinical or financial concerns. Most providers thought their skills adequate to teach disease self-management behaviors. Patients requested more information and longer visit times.
Providers view gout as easily managed while patients report challenges and purposeful nonadherence.
PMCID: PMC3134238  PMID: 20675361
medication use; gout treatment; medication adherence; qualitative
24.  Erratum to: The Dietary Quality of Persons with Heart Failure in NHANES 1999–2006 
Dietary quality may impact heart failure outcomes. However, the current status of the dietary quality of persons with heart failure has not been previously reported.
To describe sodium intake, patient factors associated with sodium intake and overall dietary quality in a national sample of persons with heart failure.
Analysis of repeated cross-sectional probability sample surveys using data from National Health and Nutrition Examination Surveys (NHANES) of 1999–2000, 2001–2002, 2003–2004 and 2005–2006.
The study sample consisted of 574 persons with self-reported heart failure (mean age = 70 years; 52% women).
Diet of each survey participant was assessed using single 24 hour recall. Dietary nutrients of interest included sodium, the mainstay of heart failure dietary recommendations, and additionally potassium, calcium, magnesium, fish oils, saturated fat and fiber. Specific dietary goals were based on established guidelines.
Mean sodium intake was 2,719 mg, with 34% consuming less than 2,000 mg per day. Patient factors associated with greater sodium intake included male gender, lower education, lower income and no reported diagnosis of hypertension. Mean potassium intake was 2,367 mg/day, with no differences by type of diuretic used or renal disease status. Adherence rates to established guidelines for other nutrients were 13% for calcium, 10% for magnesium, 2% for fish oils, 13% for saturated fat and 4% for fiber.
Dietary quality of persons with selfreported heart failure was poor. Public health approaches and clinical dietary interventions are needed for persons with this increasingly prevalent clinical syndrome.
PMCID: PMC2955475
25.  What are patients actually eating: the dietary practices of cardiovascular disease patients 
Current opinion in cardiology  2010;22(5):518-521.
Purpose of review
To examine dietary quality for patients after a coronary heart disease (CHD) event using a selective review.
Recent findings
Poor dietary quality is a risk for patients before and after CHD events. Although cardiac rehabilitation programs often contain a nutrition education component and are advised for many patients, few patients attend cardiac rehabilitation. The American population experiences many difficulties with adherence to a higher-quality diet. A diet high in dietary quality is important in reducing risk of recurrent disease, yet few patients who have faced life-threatening cardiac events are adherent to such dietary recommendations.
A review of the literature indicates the need for postevent dietary evaluation and effective nutrition counseling with ongoing follow-up. In addition, we need to demonstrate the effectiveness of such approaches.
PMCID: PMC2920451  PMID: 20625282
coronary heart disease; dietary quality; secondary prevention

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