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.

Background

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.

Methods

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).

Results

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.

Conclusion

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.

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.

Background

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.

Methods/Design

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.

Discussion

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

NCT01024790

Background

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.

Methods

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.

Results

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.

Conclusion

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.

OBJECTIVE

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.

RESEARCH DESIGN AND METHODS

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.

RESULTS

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.

CONCLUSIONS

Literacy-sensitive, culturally tailored interventions can improve diabetes control among low-income Latinos; however, strategies to sustain improvements are needed.

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.

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.

Objective

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.

Results

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).

Conclusions

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.

Objective

We sought to examine patients’ and providers’ views on the treatment of gout to better understand why management is suboptimal.

Methods

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.

Results

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.

Conclusions

Providers view gout as easily managed while patients report challenges and purposeful nonadherence.

ABSTRACT

BACKGROUND

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.

OBJECTIVE

To describe sodium intake, patient factors associated with sodium intake and overall dietary quality in a national sample of persons with heart failure.

DESIGN

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.

PARTICIPANTS

The study sample consisted of 574 persons with self-reported heart failure (mean age = 70 years; 52% women).

MEASUREMENTS

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.

RESULTS

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.

CONCLUSIONS

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.

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.

Summary

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.

Background

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.

Objective

To describe sodium intake, patient factors associated with sodium intake and overall dietary quality in a national sample of persons with heart failure.

Design

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.

Participants

The study sample consisted of 574 persons with self-reported heart failure (mean age = 70 years; 52% women).

Measurements

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.

Results

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.

Conclusions

Dietary quality of persons with self-reported heart failure was poor. Public health approaches and clinical dietary interventions are needed for persons with this increasingly prevalent clinical syndrome.

Objective

To identify gaps in therapy with urate-lowering drugs for the treatment of gout as well as factors associated with resuming therapy.

Methods

We identified persons from two integrated delivery systems 18 years or older with a diagnosis of gout who initiated use of a urate-lowering drug from January 1, 2000 through June 30, 2006 and who had a gap in therapy. A gap was defined as a period of over 60 days after the completion of one prescription in which no refill for a urate-lowering drug was obtained. Survival curves were used to assess return to therapy of urate-lowering drugs. Cox proportional hazards analysis estimated the association between covariates and return to therapy.

Results

There were 4,166 new users of urate-lowering drugs (97% received allopurinol) of whom 2,929 (70%) had a gap in therapy. Among those with a gap, in 75% it occurred in the first year of therapy. Fifty percent of patients with a gap returned to therapy within 8 months, and by 4 years it was 75%. Age 45 to 74 (<45 referent) and greater duration of urate-lowering drug use prior to the gap was associated with resuming treatment within one year. In contrast, receipt of NSAIDs or glucocorticoids in the year prior to the gap was associated with a reduced likelihood of resuming therapy.

Conclusions

The majority of gout patients with gaps in urate-lowering drug use returned to treatment. More investigation is needed to better understand why patients may go for months without refilling prescriptions given the clinical consequences of nonadherence.

Objective. Depression has been associated with increased cardiovascular disease risk, and a depression-related elevation of high sensitivity C-reactive protein (hs-CRP) has been proposed as a possible mechanism. The objective of this paper is to examine association between depression and high sensitivity C-reactive protein (hs-CRP). Methods. Subjects consisted of 508 healthy adults (mean age 48.5 years; 49% women, 88% white) residing in central Massachusetts. Data were collected at baseline and at quarterly intervals over a one-year period per individual. Multivariable linear mixed models were used to assess the association for the entire sample and by gender. Results. The mean Beck Depression Inventory score was 5.8 (standard deviation (SD) 5.4; median 4.3), and average serum hs-CRP was 1.8 mg/L (SD 1.7; median 1.2). Results from the multivariable linear mixed models show that individuals with higher depression scores have higher levels of hs-CRP. Analyses by gender show persistence of an independent association among women, but not among men. Body mass index (BMI = weight(kg)/height(m)2) appears to be a partial mediator of this relationship. Conclusion. Depression score was correlated to hs-CRP levels in women. Further studies are required to elucidate the biological mechanisms underlying these associations and their implications.

A randomized trial of a pharmacist-delivered intervention (PI) versus usual care (UC) was conducted; 689 subjects with known coronary heart disease were recruited from cardiac catheterization laboratories. Participants in the PI condition received 5 pharmacist-delivered telephone counseling calls post-hospital discharge. At one year, 65% in the PI condition and 60% in the UC condition achieved an LDL-C level <100 mg/dL (P = .29); mean statin adherence was 0.88 in the PI, and 0.90 in the UC (P = .51). The highest percentage of those who reached the LDL-C goal were participants who used statins as opposed to those who did not use statins (67% versus 58%, P = .05). However, only 53% and 56% of the patients in the UC and PI conditions, respectively, were using statins. We conclude that a pharmacist-delivered intervention aimed only at improving patient adherence is unlikely to positively affect outcomes. Efforts must be oriented towards influencing physicians to increase statin prescription rates.

Purpose

Twenty-four-hour diet recall interviews (24HRs) are used to assess diet and to validate other diet assessment instruments. Therefore it is important to know how many 24HRs are required to describe an individual's intake.

Method

Seventy-nine middle-aged white women completed seven 24HRs over a 14-day period, during which energy expenditure (EE) was determined by the doubly labeled water method (DLW). Mean daily intakes were compared to DLW-derived EE using paired t tests. Linear mixed models were used to evaluate the effect of call sequence and day of the week on 24HR-derived energy intake while adjusting for education, relative body weight, social desirability, and an interaction between call sequence and social desirability.

Results

Mean EE from DLW was 2115 kcal/day. Adjusted 24HR-derived energy intake was lowest at call 1 (1501 kcal/day); significantly higher energy intake was observed at calls 2 and 3 (2246 and 2315 kcal/day, respectively). Energy intake on Friday was significantly lower than on Sunday. Averaging energy intake from the first two calls better approximated true energy expenditure than did the first call, and averaging the first three calls further improved the estimate (p = 0.02 for both comparisons). Additional calls did not improve estimation.

Conclusions

Energy intake is underreported on the first 24HR. Three 24HRs appear optimal for estimating energy intake.

Little is known about depression among Latinos at risk for type 2 diabetes. The purpose of this cross-sectional study was to determine the rate of depression in Latinos at risk for type 2 diabetes and to examine the associations between depressive symptoms, diet, physical activity, and body mass index (BMI). Latinos at risk for type 2 diabetes (N=210) were surveyed from July 2007-August 2008. Depressive symptoms were assessed using the Center for Epidemiological Studies-Depression Scale (CES-D). Three 24-hour recalls were used to assess diet and physical activity. Linear regression analyses were used to examine the association between depression, BMI, and lifestyle factors. The sample (78% female) was largely of Caribbean origin (83%) and mean age was 52 years (standard deviation; SD=11). Mean BMI was 34.2 kg/m2 (SD=5.9) and 77% were obese. Average CES-D score was 16.3 (SD= 11.3, range 0-45) and 50% had CES-D of 16 or greater, suggesting clinical depression. Higher CES-D scores were associated with lower diet quality (p<.05), but were not associated with BMI or physical activity. Depression and lower dietary quality may contribute to risk for type 2 diabetes among Latinos.

BACKGROUND

Cross-sectional studies have reported seasonal variation in high-sensitivity C-reactive protein (hsCRP). However, longitudinal data are lacking.

METHODS

We collected data on diet, physical activity, psychosocial factors, physiology, and anthropometric measurements from 534 healthy adults (mean age 48 years, 48.5% women, 87% white) at quarterly intervals over a 1-year period between 1994 and 1998. Using sinusoidal regression models, we estimated peak-to-trough amplitude and phase of the peaks.

RESULTS

At baseline, average hsCRP was 1.72 mg/L (men, 1.75 mg/L; women, 1.68 mg/L). Overall seasonal variation amplitude was 0.16 mg/L (95% CI 0.02 to 0.30) and was lower in men (0.10 mg/L, 95% CI−0.11 to 0.31) than in women (0.23 mg/L, 95% CI 0.04 to 0.42). In both sexes, hsCRP peaked in November, with a corresponding trough in May. Relative plasma volume, waist and hip circumference, diastolic blood pressure, and depression scores were major factors associated with changes in amplitude of seasonal variation of hsCRP, and taken together explain most of the observed seasonal change. There was a 20% increase in the percentage of participants classified in the high-risk category for hsCRP (≥3 mg/L) during late fall and early winter compared with late spring and early summer.

CONCLUSIONS

Concentrations of hsCRP were modestly increased in fall and winter compared to summer, with greater seasonal amplitude of variation observed in women. Conventional classification methods fail to consider seasonality in hsCRP and may result in substantial misclassifications in the spring and fall. Future clinical practice and research should take these variations into account.

Background

The current food pyramid guidelines have been criticized because of their complexity and the knowledge required for users to understand the recommendations. Simplification of a dietary message to focus on a single key aspect of dietary quality, e.g., fiber intake, may make the message much easier to comprehend and adhere, such that respondents can achieve greater weight loss, better dietary quality and overall metabolic health.

Methods and design

This is a randomized controlled clinical trial with two equal sized arms. In total, 240 obese adults who meet diagnostic criteria for the metabolic syndrome will be randomized to one of the two conditions: 1) a high fiber diet and 2) the American Heart Association (AHA) diet. In the high fiber diet condition, patients will be given instruction only on achieving daily dietary fiber intake of 30 g or more. In the AHA diet condition, patients will be instructed to make the several dietary changes recommended by the AHA 2006 guidelines. The trial examines participant weight loss and dietary quality as well as changes in components of the metabolic syndrome, inflammatory biomarkers, low-density lipoprotein cholesterol levels, insulin levels, and glycosolated hemoglobin. Potential mediators, i.e., diet adherence and perceived ease of the diet, and the intervention effect on weight change will also be examined.

Discussions

The purpose of this paper is to outline the study design and methods for testing the simple message of increasing dietary fiber. If the simple dietary approach is found efficacious for weight loss; and, improves dietary quality, metabolic health, and adherence, it might then be used to develop a simple public health message.

Trial registration

NCT00911885

Background

Despite the potentially life-saving benefits of the implantable cardioverter-defibrillator (ICD), a significant group of patients experiences emotional distress after ICD implantation. Different psychosocial interventions have been employed to improve this condition, but previous reviews have suggested that methodological issues may limit the validity of such interventions. Aim: To review the methodology of previously published studies of psychosocial interventions in ICD patients, according to CONSORT statement guidelines for non-pharmacological interventions, and provide recommendations for future research.

Methods

We electronically searched the PubMed, PsycInfo and Cochrane databases. To be included, studies needed to be published in a peer-reviewed journal between 1980 and 2008, to involve a human population aged 18+ years and to have an experimental design.

Results

Twelve studies met the eligibility criteria. Samples were generally small. Interventions were very heterogeneous; most studies used cognitive behavioural therapy (CBT) and exercise programs either as unique interventions or as part of a multi-component program. Overall, studies showed a favourable effect on anxiety (6/9) and depression (4/8). CBT appeared to be the most effective intervention. There was no effect on the number of shocks and arrhythmic events, probably because studies were not powered to detect such an effect. Physical functioning improved in the three studies evaluating this outcome. Lack of information about the indication for ICD implantation (primary vs. secondary prevention), limited or no information regarding use of anti-arrhythmic (9/12) and psychotropic (10/12) treatment, lack of assessments of providers' treatment fidelity (12/12) and patients' adherence to the intervention (11/12) were the most common methodological limitations.

Conclusions

Overall, this review supports preliminary evidence of a positive effect of psychosocial interventions on anxiety and physical functioning in ICD patients. However, these initial findings must be interpreted cautiously because of important methodological limitations. Future studies should be designed as large RCTs, whose design takes into account the specific challenges associated with the evaluation of behavioural interventions.

Background

US Latinos have greater prevalence of type 2 diabetes (diabetes), uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos.

Methods and design

This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control) on glycemic control among low-income Latinos with diabetes, compared to usual care (control). Participants were recruited from five community health centers (CHCs) in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate) to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%.

Discussion

Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need.

Trial registration

http://www.clinicaltrials.gov # NCT00848315

Objective

Systemic inflammation may play an important role in the development of atherosclerosis, type 2 diabetes, and some cancers. Few studies have comprehensively assessed the direct relationships between dietary fiber and inflammatory cytokines, especially in minority populations. Using baseline data from 1,958 postmenopausal women enrolled in the Women’s Heath Initiative Observational Study, we examined cross-sectional associations between dietary fiber intake and markers of systemic inflammation (including serum C-reactive protein (hs-CRP), interleukin 6 (IL-6), and tumor necrosis factor α receptor 2 (TNF-α-R2)), as well as differences in these associations by ethnicity.

Method

Multiple linear regression models were used to assess the relationship between fiber intake and makers of systemic inflammation.

Results

After adjustment for covariates, intake of dietary fiber were inversely associated with both IL-6 (P values for trend were 0.01 for total fiber, 0.004 for soluble fiber, and 0.001 for insoluble fiber) and TNF-α-R2 (P values for trend were 0.002 for total, 0.02 for soluble, and <0.001 for insoluble fiber). Although the sample sizes were small in minority Americans, results were generally consistent with that found among European-Americans. We did not observe any significant association between intake of dietary fiber and hs-CRP.

Conclusions

These findings lend support to the hypothesis that a high-fiber diet is associated with lower plasma levels of IL-6 and TNF-α-R2. Contrary to previous reports, however, there was no association between fiber and hs-CRP among postmenopausal women. Future studies on the influence of diet on inflammation should include IL-6 and TNF-α-R2 and enroll participants from ethnic minorities.

Objective

This study examined the relationship between quality of dietary carbohydrate intake, as measured by glycemic index (GI) and glycemic load (GL), and high sensitivity serum C-reactive protein (hs-CRP) levels.

Method

During a one-year observational study, data were collected at baseline and at each quarter thereafter. GI and GL were calculated from multiple 24-hour dietary recalls (24HRs), three randomly selected 24HRs at every quarter, with up to fifteen 24HRs per participant. Hs-CRP was measured in blood samples collected at baseline and each of the four quarterly measurement points. Multivariable linear mixed models were used to examine both the cross-sectional and the longitudinal association of GI, GL, and hs-CRP.

Results

Among 582 adult men and women with at least two measures of both diet and hs-CRP, average daily GI score (white bread=100) was 85 and average GL was 198, Average hs-CRP was 1.84 mg/l. Overall, there was no association between either GI or GL and hs-CRP. Subgroup analyses revealed an inverse association between GL and hs-CRP, among obese individuals (body mass index ≥30 kg/m2).

Conclusions

Quality of dietary carbohydrates does not appear to be associated with serum hs-CRP levels. Among obese individuals higher dietary GL appears to be related to lower hs-CRP levels. Due to the limited number of studies on this topic and their conflicting results, further investigation is warranted.

Introduction

Adherence to urate-lowering drugs (ULDs) has not been well evaluated among those with gout. Our aim was to assess the level and determinants of non-adherence with ULDs prescribed for gout.

Methods

We identified persons using two integrated delivery systems aged 18 years or older with a diagnosis of gout who initiated use of allopurinol, probenecid or sulfinpyrazone from 1 January 2000 to 30 June 2006. Non-adherence was measured using the medication possession ratio (MPR) over the first year of therapy and defined as an MPR < 0.8. Descriptive statistics were calculated and logistic regression was used to estimate the strength of the association between patient characteristics and non-adherence.

Results

A total of 4,166 gout patients initiated ULDs; 97% received allopurinol. Median MPR for any ULD use was 0.68 (interquartile range (IQR) 0.64). Over half of the patients (56%) were non-adherent (MPR < 0.8). In adjusted analyses, predictors of poor adherence included younger age (odds ratio (OR) 2.43, 95% confidence interval (CI) 1.86 to 3.18 for ages <45 and OR 1.44, 95% CI 1.08 to 1.93 for ages 45 to 49), fewer comorbid conditions (OR 1.46, 95% CI 1.20 to 1.77), no provider visits for gout prior to urate-lowering drug initiation (OR 1.28, 95% CI 1.05 to 1.55), and use of non-steroidal anti-inflammatory drugs in the year prior to urate-lowering drug initiation (OR 1.15, 95% CI 1.00 to 1.31).

Conclusions

Non-adherence amongst gout patients initiating ULDs is exceedingly common, particularly in younger patients with less comorbidity and no provider visits for gout prior to ULD initiation. Providers should be aware of the magnitude of non-adherence with ULDs.