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Background: Most seriously ill older adults visit the emergency department (ED) near the end of life, yet no feasible method exists to empower them to formulate their care goals in this setting. Objective: To develop an intervention to empower seriously ill older adults to formulate their future care goals in the ED. Design: Prospective intervention development study. Setting: In a single, urban, academic ED, we refined the prototype intervention with ED clinicians and patient advisors. We tested the intervention for its acceptability in English-speaking patients ≥65 years old with serious illness or patients whose treating ED clinician answered “No” to the “surprise question” (“would not be surprised if died in the next 12 months”). We excluded patients with advance directives or whose treating ED clinician determined the patient to be inappropriate. Measurements: Our primary outcome was perceived acceptability of our intervention. Secondary outcomes included perceived main intent and stated attitude toward future care planning. Results: We refined the intervention with 16 mock clinical encounters of ED clinicians and patient advisors. Then, we administered the refined intervention to 23 patients and conducted semistructured interviews afterward. Mean age of patients was 76 years, 65% were women, and 43% of patients had metastatic cancer. Most participants (n = 17) positively assessed our intervention, identified questions for their doctors, and reflected on how they feel about their future care. Conclusion: An intervention to empower seriously ill older adults to understand the importance of future care planning in the ED was developed, and they found it acceptable.

OBJECTIVE Assess the effectiveness of an interdisciplinary geriatric team intervention in decreasing symptoms of depression among urban minority older adults in primary care. Secondary outcomes included cardiometabolic syndrome and trauma. METHOD 250 African American and Hispanic older adults with PHQ-9 scores ≥ 8 and BMI ≥ 25 were recruited from 6 underserved urban primary care clinics. Intervention arm participants received the BRIGHTEN Heart team intervention plus membership in Generations, an older adult educational activity program; comparison participants received only Generations. RESULTS Both arms demonstrated clinically significant improvements in PHQ-9 scores at 6 months (-5 points, intervention and comparison) and 12 months (-7 points intervention, -6.5 points comparison); there was no significant difference in change scores between groups on depression or cardiometabolic syndrome at 6 months; there was a small difference in depression trajectory at 12 months (p < .001). More participants in the treatment group (70.7%) had greater than 50% reduction in PHQ-9 scores than the comparison group (56.3%; p = .036). For those with higher PTSD symptoms (PCL-C6), improvement in depression was significantly better in the intervention arm than the comparison arm, regardless of baseline PHQ-9 (p = .001). In mixed models, those with higher PTSD symptoms (β = -0.012, p = < 0.001) in the intervention arm showed greater depression improvement than those with lower PTSD symptoms (β = -0.004, p = .001). CONCLUSIONS The BRIGHTEN Heart intervention may be effective in reducing depression for urban minority older adults. Further research on team care interventions and screening for PTSD symptoms in primary care is warranted. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Existence of an alternative explanation for the benefit of a treatment is a confounder. It is a nuisance “passenger” variable that rides along with treatment and undermines the ability to make causal inferences. This chapter focuses on why random assignment is so powerful and should be protected. It presents a history of attempts to answer the question of whether or not a treatment works, and the arrival at random assignment as the best way to make causal inferences about the benefits of a treatment. It defines confounding as an error of interpretation and the essential role of avoiding it by protecting the random assignment. It then goes on to illustrate ways to protect random assignment in the design, conduct, and analyses of a trial, with particular attention to the central role of identifying a patient-centered target population, recruiting it, retaining it, and insuring that all randomized participants are included in the evaluation of trial results.

To close the gap between evidence-based behavioral treatments for chronic diseases and their uptake in clinical practice, this book aims to encourage the development of evidence for the value of behavioral treatments that meets the standards for quality that exist in medicine. Evidence for quality is strongest in Phase III efficacy trials which follow the agreed-upon “rules” for clinical trial methods. In the behavioral clinical trial literature, there are many more Phase II than Phase III trials. What is needed is not a larger quantity of such evidence, but a higher quality of evidence using the standards that exist in medicine. This book applies a progressive, translational science model to achieve that goal.

This chapter defines feasibility and pilot studies according to the 2010 CONSORT guidelines. Feasibility studies are always linked to a planned clinical trial. Pilot studies are a subset of feasibility studies that use an identical randomized design as the planned clinical trial but are conducted to answer questions about the feasibility of a protocol. Pilot studies are distinct from miniature efficacy trials. Although both are conducted on a small number of participants and use a randomized design, pilot studies focus on feasibility, but miniature efficacy trials claim to provide estimates of efficacy. The evolving literature on behavioral trial methodology has shown a variety of problems that result from estimating efficacy with underpowered miniature efficacy trials. Recommendations are to prepare for a definitive behavioral clinical trial by making a strong case for its credibility, plausibility, and feasibility and by estimating effect sizes using targets needed to achieve clinically significant benefit. The popular practice of conducting miniature efficacy trials which are loosely linked to a planned behavioral trial, calling them pilot studies, drawing conclusions about potential efficacy, and using results to estimate sample size should be discontinued.

This chapter proposes a progressive, translational model for developing behavioral treatments for chronic diseases. It begins by describing the long-standing, evolving, and widely accepted process of drug development. It then draws on basic elements of this process to present the revised ORBIT model for developing behavioral treatments for chronic diseases. This model pushes toward Phase III behavioral efficacy testing in three progressive phases: (1) Discovery of an important clinical problem and a basic science underpinning for a behavioral treatment that could solve it; (2) Design of the treatment by first assembling basic elements and then refining them to enhance efficiency without sacrificing efficacy; and (3) Preliminary Testing of a fixed protocol using proof-of-concept studies, feasibility studies, and Phase II behavioral trials with behavioral and biomedical outcomes. Recommendations for fostering translational behavioral treatment research are suggested for funding agencies, publication practices, and investigators.

Socioeconomically disadvantaged patients are at an increased risk for adverse heart failure (HF) outcomes based upon nonadherence to medications and diet. Physicians are also suboptimally adherent to prescribing evidence-based therapy for HF.Congestive Heart Failure Adherence Redesign Trial (CHART) (NCT01698242) is a multicenter, bilevel, cluster randomized behavioral efficacy trial designed to assess the impact of intervening simultaneously on physicians and their socioeconomically disadvantaged patients (annual income$30,000) having HF with reduced ejection fraction. Treatment arm physicians received individualized feedback on their adherence to prescribing evidence-based therapy. Their patients received weekly home visits from community health workers aimed at promoting understanding of HF and integrating adherence into daily life. Control arm physicians received regular updates on advances in HF management, and patients received monthly HF educational tip sheets produced by the American Heart Association. The primary outcome was all-cause hospital days over 30 months.A total of 72 physicians (treatment, 35; control, 37) and their 320 patients (treatment, 157; control, 163) were recruited within 2 years. Randomization of physicians with all of their patients being assigned to the same arm was feasible and did not compromise the comparability of patients by arm. Using 5 recruiting hospitals located within disadvantaged neighborhoods produced a cohort that was primarily African American and representative of low-income urban patients with HF with reduced ejection fraction.CHART will determine the value of intervening on low adherence simultaneously in physicians and their socioeconomically disadvantaged patients in reducing all-cause hospitalization days.

BackgroundHigher perivascular adipose tissue (PVAT) contributes to adverse physiologic alterations in the vascular wall, and thus could potentially limit normal physical function later in life. We hypothesize that higher PVAT volume at midlife is prospectively associated with slower gait speed later in life, independent of overall adiposity and other risk factors.MethodsParticipants from the Study of Women’s Health Across the Nation (SWAN) cardiovascular fat ancillary study were included. PVAT volume around the descending aorta was quantified using existing computed tomography scans at midlife, while gait speed was measured after an average of 10.4 ± 0.7 years.ResultsTwo hundred and seventy-six women (aged 51.3 ± 2.8 years at PVAT assessment) were included. Mean gait speed was 0.96 ± 0.21 m/s. Adjusting for study site, race, education level, menopausal status, and length of descending aorta at PVAT assessment, and age, body mass index, difficulty paying for basics, overall health and smoking status at gait speed assessment, a higher midlife PVAT volume was associated with a slower gait speed later in life (p = .03). With further adjustment for presence of any comorbid conditions by the time of gait speed assessment, the association persisted; every 1SD increase in log-PVAT was associated with 3.3% slower gait speed (95% confidence interval: 0.3–6.3%; p = .03).ConclusionGreater PVAT in midlife women may contribute to poorer physical function in older age supporting a potential role of midlife PVAT in multiple domains of healthy aging. Additional research is needed to fully elucidate the physiologic changes associated with PVAT that may underlie the observed associations.

Background Changes in reproductive hormones during menopause are associated with accumulation of intra-abdominal adipose tissue (IAAT), a subclinical indicator of cardiometabolic disease risk. Independent of reproductive hormones, unhealthy lifestyle contributes to IAAT gain. The Women in the Southside Health and Fitness (WISHFIT) Study aims to develop a lifestyle approach to slowing IAAT accumulation as women begin the menopausal transition. Methods The primary aim is to develop and conduct a proof-of-concept test of a multi-component, multi-level behavioral intervention targeting jointly physical activity, diet, and psychological well-being. Participants attend group sessions over 2 years to experiment with healthy living through both experiential and didactic learning, cultivate a health network, and draw on community resources to sustain change. The primary endpoint is 2-year IAAT progression, assessed using computerized tomography. Behavioral targets of treatment and secondary endpoints will be evaluated at 6, 12, 18 and 24 months. Change in social networks and community support will be assessed at 2 years. Results WISHFIT recruited 71 pre- and peri-menopausal Caucasian and African American women (mean ± SD age = 47.6 ± 3.4 yrs; BMI = 33.6 ± 7.3 kg/m2; 52% African American). Baseline IAAT was 2104.1 ± 1201.3 cm3. IAAT, physical activity, BMI, and self-reported family income and resilience differed by ethnicity at baseline. Conclusions WISHFIT is a multi-component, multi-level intervention aimed at producing a sustained improvement in physical activity, diet, and psychological well-being early in the menopausal transition to slow menopause-related accumulation of IAAT. It provides a model for the process of developing a behavioral treatment to manage a chronic disease.

Background:Physical inactivity in midlife women is associated with increased intra-abdominal adipose tissue development. We describe an innovative multimethod study 1) to better understand barriers to physical activity (PA) and 2) to engage midlife women to product test physical activities and identify local community-based providers and sustainable and fun PA experiences.Methods:Formative research on PA barriers from the Chicago site Study of Women’s Health Across the Nation (SWAN) ancillary study of midlife women was used to develop a pilot testing measure. Feasibility, acceptability and sustainability of the PA activities were determined using the measure.Results:Desirable locations and/or instructors were identified. The first 2 groups identified, pilot tested, and then ranked activities for their ability to promote sustained PA. The 6 top-ranked were: circuit training, total body fitness, kickboxing, Zumba, Pilates, and pedometer. The final group pilot tested highly ranked PA in 2-week blocks, and ranked pedometer and Zumba in their top 3.Conclusion:Consensus was reached regarding activities that could be valuable in promoting sustained PA in midlife women. Choosing convenient sites and popular instructors further facilitates sustainability. Building relationships with key community partners is essential for sustainability. Community-based participant involvement in study design is a critical element in developing a healthy living intervention.

Background and Purpose— Emerging work has linked menopausal vasomotor symptoms (VMS) to subclinical cardiovascular disease (CVD) among women. However, VMS are dynamic over time. No studies have considered how temporal patterns of VMS may relate to subclinical CVD. We tested how temporal patterns of VMS assessed over 13 years were related to carotid intima media thickness (IMT) among midlife women. Methods— The Study of Women’s Health Across the Nation is a longitudinal cohort study of midlife women. Eight hundred and eleven white, black, Hispanic, and Chinese participants with a well-characterized final menstrual period completed measures of VMS, a blood draw, and physical measures approximately annually for 13 years. Women underwent a carotid artery ultrasound at study visit 12. Results— Four trajectories of VMS were identified by trajectory analysis (consistently high, early-onset, late-onset, persistently low VMS) and tested in relation to carotid indices in linear regression models. Results indicated that women with early-onset VMS had both greater mean IMT (beta, b [standard error, SE]=0.03 [0.01], P =0.03) and greater maximal IMT (b [SE]=0.04 [0.01], P =0.008) than women with consistently low VMS, adjusting for demographics and CVD risk factors. Conclusions— This is the first study to test trajectories of VMS in relation to subclinical CVD. Women with VMS early in the menopause transition had higher mean IMT and maximal IMT than those with consistently low VMS across the transition. Associations were not accounted for by demographic factors nor by CVD risk factors. Results can signal to women in need of early CVD risk reduction.

Traumatic events and posttraumatic stress disorder (PTSD) are associated with increased risk for cardiopulmonary disease (CPD) in veterans, men, and primarily White populations. Less is known about trauma, PTSD, and CPD burden among low-income, racial minority residents who are at elevated risk for trauma and PTSD. It was hypothesized that traumatic events and PTSD would be significantly associated with CPD burden among low-income, racial minority residents.We evaluated cross-sectional relationships between traumatic events, PTSD, depression, and CPD burden in 251 low-income, urban, primarily Black adults diagnosed with heart failure. Data were analyzed using bivariate analyses, logistic and linear regression.Forty-three percent endorsed at least one traumatic event. Twenty-one percent endorsed two or more traumatic events. In logistic regression analyses, traumatic events were associated with increased prevalence of coronary artery disease (adjusted odds=1.33, p.05), hypertension (adjusted odds=1.28, p.05), chronic obstructive pulmonary disease (adjusted odds=1.52, p.01), and cardiac arrest (adjusted odds=1.27, p.05). PTSD was also related to increased risk for chronic obstructive pulmonary disease (adjusted odds=1.22, p.05) and was associated with earlier onset of heart failure (β=-.13, p.05).The study utilizes cross-sectional, self-report data.Findings support the link between traumatic events, PTSD, and CPD burden in low-income, primarily Black patients with heart failure. Depression appears to be less closely linked to CPD burden, despite receiving significant attention in the literature. The accumulation of traumatic events may exacerbate CPD burden among urban, low-income, racial minority residents with heart failure; findings highlight the importance of PTSD screening.

Background Factors at multiple ecological levels, including the child, family, home, medical care, and community, impact adolescent asthma outcomes. Objective This systematic review characterizes behavioral interventions at the child, family, home, medical system, and community level to improve asthma management among adolescents. Methods A systematic search of PubMed, SCOPUS, OVID, PsycINFO, CINAHL, and reference review databases was conducted from January 1, 2000, through August 10, 2014. Articles were included if the title or abstract included asthma AND intervention AND (education OR self-management OR behavioral OR technology OR trigger reduction), and the mean and/or median age of participants was between 11 and 16 years. We compared populations, intervention characteristics, study designs, outcomes, settings, and intervention levels across studies to evaluate behavioral interventions to improve asthma management for adolescents. Results Of 1230 articles identified and reviewed, 24 articles (21 unique studies) met inclusion criteria. Promising approaches to improving adherence to daily controller medications include objective monitoring of inhaled corticosteroid adherence with allergist and/or immunologist feedback on medication-taking behavior and school nurse directly observed therapy. Efficacy at increasing asthma self-management skills was demonstrated using group interactive learning in the school setting. This systematic review is not a meta-analysis, thus limiting its quantitative assessment of studies. Publication bias may also limit our findings. Conclusions Novel strategies to objectively increase controller medication adherence for adolescents include allergist and/or immunologist feedback and school nurse directly observed therapy. Schools, the most common setting across studies in this review, provide the opportunity for group interactive learning to improve asthma knowledge and self-management skills.

This study sought to evaluate the impact of sodium restriction on heart failure (HF) outcomes.Although sodium restriction is advised for patients with HF, data on sodium restriction and HF outcomes are inconsistent.We analyzed data from the multihospital HF Adherence and Retention Trial, which enrolled 902 New York Heart Association functional class II/III HF patients and followed them up for a median of 36 months. Sodium intake was serially assessed by a food frequency questionnaire. Based on the mean daily sodium intake prior to the first event of death or HF hospitalization, patients were classified into sodium restricted (2,500 mg/d) and unrestricted (≥2,500 mg/d) groups. Study groups were propensity score matched according to plausible baseline confounders. The primary outcome was a composite of death or HF hospitalization. The secondary outcomes were cardiac death and HF hospitalization.Sodium intake data were available for 833 subjects (145 sodium restricted, 688 sodium unrestricted), of whom 260 were propensity matched into sodium restricted (n = 130) and sodium unrestricted (n = 130) groups. Sodium restriction was associated with significantly higher risk of death or HF hospitalization (42.3% vs. 26.2%; hazard ratio [HR]: 1.85; 95% confidence interval [CI]: 1.21 to 2.84; p = 0.004), derived from an increase in the rate of HF hospitalization (32.3% vs. 20.0%; HR: 1.82; 95% CI: 1.11 to 2.96; p = 0.015) and a nonsignificant increase in the rate of cardiac death (HR: 1.62; 95% CI: 0.70 to 3.73; p = 0.257) and all-cause mortality (p = 0.074). Exploratory subgroup analyses suggested that sodium restriction was associated with increased risk of death or HF hospitalization in patients not receiving angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (HR: 5.78; 95% CI: 1.93 to 17.27; p = 0.002).In symptomatic patients with chronic HF, sodium restriction may have a detrimental impact on outcome. A randomized clinical trial is needed to definitively address the role of sodium restriction in HF management. (A Self-management Intervention for Mild to Moderate Heart Failure [HART]; NCT00018005).

OBJECTIVE The aim was to describe the early phases of the progressive development of a lifestyle treatment for sustained remission of the metabolic syndrome (MetS) using the Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral treatment development as a guide. METHODS Early discovery and design phases produced a 3-component (diet, physical activity, stress), group-based lifestyle treatment with an intensive 6-month phase followed by monthly, participant-led maintenance meetings. In the proof-of-concept phase, 26 participants with the MetS (age 53 ± 7 years, 77% female, and 65% ethnic minority) were recruited in a quasi-experimental design to determine if treatment could achieve the prespecified benchmark of MetS remission in ≥50% at 2.5 years. Exploratory outcomes focused on MetS components, weight, and patient-centered benefits on energy/vitality and psychosocial status. RESULTS MetS remission was achieved in 53.8% after a median of 2.5 years. At 2.5 years, an increase of +15.4% reported eating ≥3 servings of vegetables/day, +7.7% engaged in ≥150 minutes of moderate-to-vigorous physical activity/week; and +11.5% reported experiencing no depression in the past 2 weeks. Weight loss ≥5% was achieved by 38.5%, and energy/vitality, negative affect, and social support improved. Median group attendance over 2.5 years was 73.8%. CONCLUSIONS It is plausible that this lifestyle program can produce a remission in the MetS, sustained through 2.5 years. After refinements to enhance precision and strength, progression to feasibility pilot testing and a randomized clinical trial will determine its efficacy as a cost-effective lifestyle option for managing the MetS in the current health care system. (PsycINFO Database Record

Cardiovascular disease risk increases in women after the menopausal transition; why this inflection point occurs remains uncertain. We aimed to characterize the influence of menopause on vascular aging by prospective assessment of change in indexes of subclinical atherosclerosis across the menopausal transition. We evaluated 411 healthy women from SWAN Heart, an ancillary study of SWAN (Study of Women's Health Across the Nation), for subclinical atherosclerosis at baseline and again after an average of 2.3 years. Carotid intima-media thickness and aortic pulse wave velocity were measured by ultrasound. Coronary artery calcium scores were obtained by computed tomography. Women were grouped by menopausal status as premenopausal, postmenopausal, or having undergone the transition during follow-up. Analyses of changes were adjusted for age at baseline and time between scans. Mean age at baseline was 51 ± 3 years; 93 (23%) subjects transitioned to menopause (Pre-Post), 147 (36%) remained premenopausal (Pre-Pre), while 171 (41%) were postmenopausal at baseline (Post-Post). Blood pressure readings did not differ between groups with similar increase noted in carotid intima-media thickness and log coronary artery calcium + 1 from baseline to follow-up. Change in aortic pulse wave velocity from baseline to follow-up was higher in Pre-Post (121 ± 23 cm/s) compared with Pre-Pre (38 ± 250 cm/s, p = 0.029) and Post-Post (41 ± 228 cm/s, p = 0.045). In conclusion, changes in aortic stiffness were more sensitive measures of perimenopausal vascular aging than morphologic indexes of subclinical atherosclerosis in women undergoing the menopausal transition. Serial assessment of such changes could potentially elucidate mechanisms of disease and identify women to target for aggressive lifestyle risk factor modification.

Copyright © 2015 by the Endocrine Society. Context: Cardiovascular risk increases in women after menopause. Mounting evidence demonstrates a role of cardiovascular fat (CF) in the pathogenesis of coronary heart disease, but no research has examined CF in relation to sex hormones or menopausal status in women. Objective: The objective was to determine the relationship between CF depots, menopausal status, and endogenous sex hormones. Design: Cross-sectional and longitudinal study designs were used. Setting: The setting included the Study of Women's Health Across the Nation (SWAN) Heart and Cardiovascular Fat Ancillary Study. Participants: A total of 456 women (mean age, 50.75 y); 62% premenopausal/early perimenopausal, and 38% late peri-/postmenopausal. Intervention: Menopausal status, endogenous sex hormones measured simultaneously with CF volumes, and circulating estradiol available 4.80 years (median) before CF measures. MainOutcomeMeasures: Volumes of CF (epicardial adipose tissue [EAT], paracardial adipose tissue [PAT], total heart adipose tissue [TAT=EAT=PAT], and aortic perivascular adipose tissue [PVAT]). Results: In final models, late peri-/postmenopausal women had 9.88% more EAT, 20.72% more PAT, and 11.69% more TAT volumes than pre-/early perimenopausal women (P < .05). PVAT was not associated with menopausal status. In final models, lower estradiol concentrations were associated with greater volumes of PAT and TAT (P < .05). Women with the greatest reduction in estradiol since baseline had greater volumes of PAT compared to women with the least reduction (P = .02). Conclusions: Late peri-/postmenopausal women have greater volumes of heart fat compared with pre-/early perimenopausalwomenindependent of age, obesity, and other covariates. Endogenous sex hormones are associated with CF. Perhaps CF plays a role in the higher risk of coronary heart disease reported in women after menopause.

Objective To determine whether baseline levels and longitudinal changes in meal preparation and cleanup time are associated with changes in cardiometabolic risk factors in midlife women. Methods Subjects were 2755 midlife women enrolled in the Study of Women's Health Across the Nation, a multi-ethnic, longitudinal cohort study in the United States. The five diagnostic components of the metabolic syndrome and meal preparation/cleanup time were assessed repeatedly across 14 years of follow-up (spanning 1996–2011) at seven U.S. sites. Mixed-effects logistic and ordered logistic models tested associations between meal preparation/cleanup time and odds of meeting criteria for metabolic syndrome and its individual diagnostic components. Results Women who spent more time preparing and cleaning up meals at baseline, or demonstrated greater increases in this activity, had greater increases over time in their odds of having metabolic syndrome and in the number of metabolic syndrome components for which they met criteria. Adjusted associations were observed between meal preparation/cleanup time and hypertension, impaired fasting glucose, hypertriglyceridemia, and low high-density lipoprotein cholesterol, but not abdominal obesity. Conclusions In midlife women, greater meal preparation/cleanup time is associated with the development of an adverse cardiometabolic risk profile. Public health interventions should place greater emphasis on cooking healthfully, not just cooking frequently.

Posttraumatic stress disorder (PTSD) and Major Depressive Disorder (MDD) are associated with high disease burden. Pathways by which PTSD and MDD contribute to disease burden are not understood.Path analysis was used to examine pathways between PTSD symptoms, MDD symptoms, and disease burden among 251 low-income heart failure patients.In Model 1, we explored the independent relationship between PTSD and MDD symptoms on disease burden. In Model 2, we examined the association of PTSD symptoms and disease burden on MDD symptoms. We also examined indirect associations of PTSD symptoms on MDD symptoms, mediated by disease burden, and of PTSD symptoms on disease burden mediated by MDD symptoms.Disease burden correlated with PTSD symptoms (r = .41; p.001) and MDD symptoms (r = .43; p.001) symptoms. Both models fit the data well and displayed comparable fit. MDD symptoms did not mediate the association of PTSD symptoms with disease burden. Disease burden did mediate the relationship between PTSD symptoms and MDD symptoms.Results support the importance of detection of PTSD in individuals with disease. Results also provide preliminary models for testing longitudinal data in future studies.

Background Volumes of paracardial adipose tissue ( PAT ) and epicardial adipose tissue ( EAT ) are greater after menopause. Interestingly, PAT but not EAT is associated with estradiol decline, suggesting a potential role of menopause in PAT accumulation. We assessed whether volumes of heart fat depot ( EAT and PAT ) were associated with coronary artery calcification ( CAC ) in women at midlife and whether these associations were modified by menopausal status and estradiol levels. Methods and Results EAT and PAT volumes and CAC were measured using electron beam computed tomography scans. CAC was evaluated as (1) the presence of CAC ( CAC Agatston score ≥10) and (2) the extent of any CAC (log CAC Agatston score >0). The study included 478 women aged 50.9 years (58% pre‐ or early perimenopausal, 10% late perimenopausal, and 32% postmenopausal). EAT was significantly associated with CAC measures, and these associations were not modified by menopausal status or estradiol. In contrast, associations between PAT and CAC measures were modified by menopausal status (interaction‐ P ≤0.01). Independent of study covariates including other adiposity measures, each 1‐SD unit increase in log PAT was associated with 102% higher risk of CAC presence ( P =0.04) and an 80% increase in CAC extent ( P =0.008) in postmenopausal women compared with pre‐ or early perimenopausal women. Additional adjustment for estradiol and hormone therapy attenuated these differences. Moreover, the association between PAT and CAC extent was stronger in women with lower estradiol levels (interaction P =0.004). Conclusions The findings suggest that PAT is a potential menopause‐specific coronary artery disease risk marker, supporting the need to monitor and target this fat depot for intervention in women at midlife.

Objective To determine whether menopause-related changes in reproductive hormones were associated with change in adiposity and whether these relationships were independent of important covariates. Methods Annual assessments of adiposity measures [computed tomography-assessed visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) and dual-energy X-ray absorptiometry-assessed total body fat (TBF)] over 4 years from an ancillary study at the Chicago site of the Study of Women's Health Across the Nation (SWAN) were paired with reproductive hormones collected by SWAN. Included were 243 women (44% African American, 56% Caucasian) who were eligible participants in a population-based cohort with a 72% participation rate. Results VAT increased by 3.8% annually, and SAT increased by 1.8% per year. Change in bioavailable testosterone was significantly positively associated with changes both in VAT and in SAT but was not related to change in total body fat. The associations were independent of age, race, physical activity, smoking, baseline TBF, baseline bioavailable testosterone, and change in TBF. Change in estradiol was unrelated to changes in any adiposity measure. Conclusions Bioavailable testosterone may play an important role in menopause-related redistribution of visceral and subcutaneous fat in the central abdominal region.

Objectives. We assessed whether community health workers (CHWs) could improve glycemic control among Mexican Americans with diabetes. Methods. We recruited 144 Mexican Americans with type 2 diabetes between January 2006 and September 2008 into the single-blinded, randomized controlled Mexican American Trial of Community Health Workers (MATCH) and followed them for 2 years. Participants were assigned to either a CHW intervention, delivering self-management training through 36 home visits over 2 years, or a bilingual control newsletter delivering the same information on the same schedule. Results. Intervention participants showed significantly lower hemoglobin A1c levels than control participants at both year 1 Δ = −0.55; P = .021) and year 2 (Δ = −0.69; P = .005). We observed no effect on blood pressure control, glucose self-monitoring, or adherence to medications or diet. Intervention participants increased physical activity from a mean of 1.63 days per week at baseline to 2.64 days per week after 2 years. Conclusions. A self-management intervention delivered by CHWs resulted in sustained improvements in glycemic control over 2 years among Mexican Americans with diabetes. MATCH adds to the growing body of evidence supporting the use of CHWs to reduce diabetes-related health disparities.

Moderate wine consumption has been associated with reduced cardiovascular (CV) risk, but most investigations have been conducted in Caucasian populations. To investigate the relationship of wine consumption to CV risk markers, we studied a multi-ethnic sample of middle-aged, healthy women (N = 2900; 48% white, 28% black, 7% Hispanic, 8% Chinese, 9% Japanese) participating in SWAN over 7 years with repeated assessments of CV risk factors. Consumption of wine was stable and common with 20% reporting none, 69% light (1/day). To guard against underreporting, we took the maximum reported wine consumption over 7 years as the predictor. We used mixed models with a random intercept and random time to assess the relationship between wine consumption and CV risk factors with moderate consumption as the reference. Outcome variables were log-transformed where necessary. Longitudinal models were adjusted for ethnicity, age, and time-varying menopausal status, hormone therapy use, overall alcohol consumption, high density lipoprotein (HDL), statin use, and a healthy lifestyle score based on physical activity, not smoking, and weight maintenance. Interactions of wine consumption with time were not significant. Moderate wine consumers had significantly lower levels of C-reactive protein (CRP, p < .001), fibrinogen (p < .001), factor VII (p < .01), and plasminogen activator inhibitor (PAI-1, p < .05) than women who drank no or little wine. These associations were independent of significant effects of healthy lifestyle and overall alcohol consumption and similar across ethnic groups. Moderate wine consumption may protect against CVD via inflammatory and clotting pathways.

Heart failure (HF) is associated with poor health-related quality of life (HRQOL). The purpose of our study is to determine the effect of a self-management intervention on HRQOL domains across time, overall, and in prespecified demographic, clinical, and psychosocial subgroups of HF patients. HART was a single-center, multi-hospital randomized trial. Patients (n = 902) were randomized either to a self-management intervention with provision of HF educational information or an enhanced education control group which received the same HF educational materials. HRQOL was measured by the Quality of Life Index, Cardiac Version, modified, and the Medical Outcomes Study 36-item Short-Form Health Survey physical functioning scale. Analyses included descriptive statistics and mixed-effects regression models. In general, overall, study participants’ HRQOL improved over time. However, no significant differences in HRQOL domain were detected between treatment groups at baseline or across time (p > 0.05). Subgroup analyses demonstrated no differences by treatment arm for change in HRQOL from baseline to 3 years later. We conclude that in our cohort of patients, the self-management intervention had no benefit over enhanced education in improving domains of HRQOL and HRQOL for specified HF subgroups.

African American and Hispanic elderly are at elevated risk of both depression and cardiovascular disease, relative to non-Hispanic whites. Effective interventions are therefore needed to address depressive symptoms and to reduce these disparities. BRIGHTEN Heart was a behavioral randomized controlled trial to test the efficacy of a virtual team intervention in reducing depressive symptoms in minority elderly as measured by the 9-item Patient Health Questionnaire (PHQ9).250 African American and Hispanic adults, age ≥60 years, with comorbid depression and overweight/obesity were randomized. Participants randomized to the Intervention condition received a social work evaluation, team-based electronic consultation, case management, and psychotherapy over a 12 month period. Control participants were enrolled in a membership program that provided health classes and other services to support chronic disease self-management. Blinded research assistants completed assessments at baseline, and 6 and 12 months postrandomization.The study population was characterized by low socioeconomic status, with 81.4% having a household income of less than $20,000. Although median depression scores were in the mild range, 25% of participants had scores showing moderate to severe depression at baseline. 75% of participants had four or more chronic conditions. Significant demographic and clinical differences were observed between the African American and Hispanic populations.BRIGHTEN Heart was designed to rigorously test the efficacy of a multi-level intervention to reduce comorbid depressive symptoms and cardiovascular risk in minority elderly. Investigators successfully recruited a cohort well suited to testing the study hypothesis.

Objective This report describes the development and validation of a technology-based system that integrates data on food choice, nutrition, and plate waste to generate feedback reports summarizing students' dietary intake at school meals. Methods Cafeteria staff used the system to document the school lunch choices of seventh-graders (n = 37) in an urban charter school for 5 months. Plate waste was assessed by research staff using a visual estimation method that was validated against directly weighed plate waste. Results Most food choices (97.1%) were correctly recorded through the system. Visual estimates of plate waste had excellent interrater reliability ( r 's ≥ .94) and agreement with direct measurements (ρ's ≥ .75). Plate waste assessment required approximately 10 s/tray. Fifty-four percent of parents received feedback reports consistently. Conclusions and Implications The technology-based system enabled staff to monitor dietary intake accurately at school meals. The system could potentially inform lunch menu modifications aimed at reducing plate waste.

The impact of physical inactivity on heart failure (HF) mortality is unclear. We analyzed data from the HF Adherence and Retention Trial (HART) which enrolled 902 patients with New York Heart Association class II/III HF, with preserved or reduced ejection fraction, who were followed for 36 months. On the basis of mean self-reported weekly exercise duration, patients were classified into inactive (0 min/week) and active (≥1 min/week) groups and then propensity score matched according to 34 baseline covariates in 1:2 ratio. Sedentary activity was determined according to self-reported daily television screen time (2, 2 to 4,4 h/day). The primary outcome was all-cause death. Secondary outcomes were cardiac death and HF hospitalization. There were 196 inactive patients, of whom 171 were propensity matched to 342 active patients. Physical inactivity was associated with greater risk of all-cause death (hazard ratio [HR] 2.01, confidence interval [CI] 1.47 to 3.00; p0.001) and cardiac death (HR 2.01, CI 1.28 to 3.17; p = 0.002) but no significant difference in HF hospitalization (p = 0.548). Modest exercise (1 to 89 min/week) was associated with a significant reduction in the rate of death (p = 0.003) and cardiac death (p = 0.050). Independent of exercise duration and baseline covariates, television screen time (4 vs2 h/day) was associated with all-cause death (HR 1.65, CI 1.10 to 2.48; p = 0.016; incremental chi-square = 6.05; p = 0.049). In conclusion, in patients with symptomatic chronic HF, physical inactivity is associated with higher all-cause and cardiac mortality. Failure to exercise and television screen time are additive in their effects on mortality. Even modest exercise was associated with survival benefit.

OBJECTIVES The present cross-sectional study aimed to a) examine associations between measures of psychological well-being, specifically life satisfaction and life engagement, and intima media thickness, a subclinical marker of atherosclerosis; b) investigate if the interaction of psychological well-being and life events correlated with intima media thickness; and c) explore these relationships across race. METHODS A sample of 485 women (38% African American and 62% white; mean [standard deviation] age = 50.2 [2.9] years) underwent ultrasonography to assess carotid artery intima media thickness (IMT). The women completed self-report measures of life satisfaction, life engagement, and life events. RESULTS Average (standard deviation) IMT was 0.666 (0.10) mm. Life satisfaction showed a significant, independent, inverse relationship with IMT, after controlling for demographic, behavioral, psychological, and cardiovascular covariates (β = -0.105, p = .039), such that each 1-point higher life satisfaction score was correlated with a significant 0.008-mm lower level of mean IMT. No significant association was seen between life events and IMT (r = 0.05, p = .32), and life satisfaction did not interact with life events on IMT (β = -0.036, p = .46). No significant interaction between life satisfaction and race on IMT was observed (β = 0.068, p = .37). In contrast to life satisfaction, life engagement was not a significant correlate of IMT (r = -0.07, p = .12). CONCLUSIONS Life satisfaction, a measure of psychological well-being, is an important independent correlate of subclinical atherosclerosis in middle-aged women.

Objectives: The body adiposity index (BAI) is a proposed alternative to the body mass index (BMI) that has shown good cross-sectional agreement with percent body fat (%BF) in validation studies. The objective of this study was to examine the ability of BAI to track adiposity change over time in a biracial sample of midlife women. Methods: African-American (n = 159) and Caucasian (n = 206) women, aged 42–60 years, at the Chicago site of the Study of Women's Health Across the Nation were followed from 2002 to 2008. BAI and BMI were calculated from measurements taken at annual assessments. %BF was quantified using whole-body dual-energy X-ray absorptiometry. Difference scores (BAIΔ, BMIΔ, and %BFΔ) quantified adiposity change over a mean of 1.6 (SD = 0.7) years. Lin's concordance correlation (ρc) and Bland–Altman limits-of-agreement assessed agreement between BAI and %BF. Results: In examining adiposity change, BAIΔ showed poor agreement with %BFΔ in the overall sample (ρc = 0.41), African-American women (ρc = 0.36), and Caucasian women (ρc = 0.43). BAIΔ estimated %BFΔ with minimal bias (+0.4%) but low precision (±6.3%BF limits-of-agreement). %BFΔ had weaker correlations with BAIΔ (rs = 0.38–0.48) than with BMIΔ (rs = 0.48–0.59). BAI and BMI showed similar cross-sectional associations with %BF in the overall sample and within each race (rs > 0.74). Conclusions: We conclude that BAI is less accurate than BMI in tracking adiposity change in midlife women, and would not be a suitable replacement for BMI in most research applications involving adiposity change. Am. J. Hum. Biol., 2012. © 2012 Wiley Periodicals, Inc.

There is a growing interest in the use of information technologies to promote asthma control and improve outcomes. This article reviews published studies, identified by a search of PubMed and CINAHL, utilizing interactive Internet and mobile device platforms to improve asthma knowledge and/or asthma outcomes. Although these studies show creativity and promise, this field is still in its infancy, characterized by small pilot studies showing mixed results. Rigorous randomized, controlled trials with large sample sizes and objective assessments are in the pipeline but more are needed. This review also describes some promising ongoing studies using information technology to improve asthma management, as well as currently available mobile applications and the use of social networking for asthma. To our knowledge, there are no published studies using interactive mobile applications or social networking platforms to improve asthma self-management.

Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention to intervention fidelity. These limitations reflect challenges in balancing methodologic rigor with the needs of vulnerable populations. The Mexican-American Trial of Community Health workers (MATCH) was a blinded randomized controlled trial testing CHW efficacy in improving physiologic outcomes and self-management behaviors among Mexican-Americans with type 2 diabetes. This paper describes methods used to overcome limitations of prior studies.The primary aim was to determine if a CHW intervention would result in significant reductions in Hemoglobin A1c and rates of uncontrolled blood pressure. 144 Mexican-Americans with diabetes were randomized. The intervention consisted of self-management training delivered by CHWs over a 24-month period; the comparison population received identical information via bilingual newsletter. Blinded research assistants completed assessments at baseline, 12 months, and 24 months post-randomization.The MATCH cohort was characterized by low acculturation and socioeconomic status. Study participants had low rates of medication adherence and glucose monitoring. 70% had poor glycemic control with A1c levels over 7.0, and 57.3% had blood pressures worse than ADA target levels (130/80).MATCH preserved community sensitivity and methodologic rigor. The study's attention to intervention fidelity, behavioral attention control, blinded outcomes assessment, and strategies to enhance participant retention can be replicated by researchers testing culturally-tailored CHW interventions.

The Heart Failure Adherence and Retention Trial (HART) provided an opportunity to determine adherence to evidence-based guidelines (EBG) in patients with heart failure (HF). Ten hospitals were the source of 692 patients with HF (EF

School-based asthma education programs targeting disadvantaged youth and teens with asthma are lacking.To assess the impact of the Fight Asthma Now (FAN) educational program among 2 populations of predominantly low-income minority students: youth (3(rd)-6(th) graders) and teens (7(th)-8(th) graders).Chicago-area elementary schools were invited to participate in this stratified 2-arm study. Eligible schools were assigned to participate either in the intervention or in the control arm. Within each participating school, eligible students were recruited and grouped (stratified by grade and age) to form teen or youth classes. Participants completed a pre- and post-intervention asthma knowledge questionnaire and observation for spacer technique competency. The treatment group received the FAN curriculum between the evaluations.A sample of 26 low-income, predominantly minority-serving schools was recruited. Most participating schools were randomized in a 3:1 ratio to form 25 youth classes (19 intervention and 6 control group) and 16 teen classes (11 intervention and 5 control group), resulting in 275 vs 69 youth and 141 vs 51 teens in the intervention and control groups, respectively. Stratified analyses were performed, and clustering within the school and class was taken into consideration in analyses. Multilevel models adjusting for school, class, ethnicity, sex, and pretest score indicate that the FAN intervention significantly increased both knowledge and spacer competency test scores, among both the youth and teen participants (P = .011 with respect to knowledge score among teen students, P.0001 for all other cases).This study suggests that FAN significantly increases asthma knowledge and spacer technique competency within this high-risk population.

OBJECTIVE The aim of this study was to examine whether obesity modifies the effects of endogenous steroid sex hormones on arterial calcification in women at midlife. METHODS Associations between estradiol, testosterone, sex hormone-binding globulin, and free androgen index and the presence and extent of coronary and aortic calcification were evaluated in 187 obese (body mass index, ≥30 kg/m) and 281 nonobese (body mass index

We investigated the relationship between wine consumption and the metabolic syndrome (MetS) in a longitudinal, eight-year study of the natural history of the menopause transition at seven geographical sites in the United States. Although similar in age, the 527 African American women had a worse metabolic profile than 1057 Caucasian women. Moderate wine consumption (one glass/day) was less common among African American women but was associated with a better lipid profile in both ethnic groups. Compared to women who drank one glass of wine per day, those who consumed no wine had twice the risk of developing the MetS.