The Cardiovascular Health Program (CHP) Registry is a 12-month, prospective study of therapeutic lifestyle change (TLC). Adult participants received comprehensive assessment of health behaviors and cardiovascular disease (CVD) risk factors. Personalized TLC action plans addressed modifiable health behaviors for diet, exercise, stress management, and sleep. Participants attended a half-day interactive workshop and met face-to-face with certified health coaches four times over 6 months. Monthly telephonic coaching for 6 more months completed the intervention. Measured outcomes included adherence to behavioral prescriptions, anthropometrics, CVD-relevant laboratory tests, and for a subset of participants, carotid intima-media thickness (CIMT). Of 965 participants, 648 (67%) completed the program and were included in the analysis. Participants were of mean age 55.4 ± 12.5 years, 57% women, and racially diverse. Adherence to prescribed TLC was substantial: dietary behaviors at goal rose from 53% to 86%, exercise 44% to 66%, perceived stress 65% to 79%, and sleep quality 28% to 49%. For participants with abnormal anthropometrics at baseline, there were improvements in body mass index in 63%, waist circumference (men 71%, women 74%), systolic BP 69%, and diastolic BP 71%. For participants with abnormal laboratory values at baseline, there were improvements in total cholesterol in 74%, LDL-cholesterol 65%, triglycerides 86%, fasting glucose 72%, and insulin resistance 71%. Improvements were not driven by prescribed medications. CIMT improved or showed no change in 70% of those measured, associated with significant improvements in sleep quality and longer total sleep time. Longer trials incorporating controls and major adverse CVD events are warranted.

Newly recognized as a clinical diagnosis, Lp(a) elevation is a major contributor to cardiovascular disease risk should be considered for patients with advanced premature atherosclerosis on imaging or a family history of premature cardiovascular disease, particularly when there are few traditional risk factors.

Although prediabetes is associated with increased cardiovascular disease (CVD) risk, it is not often targeted in CVD prevention programs. We sought to evaluate the impact of a tailored prediabetes program to reverse prediabetes and lower CVD risk. Consecutive subjects of the Integrative Cardiac

BACKGROUND:The college experience is often the first time when young adults live independently and make their own lifestyle choices. These choices affect dietary behaviors, exercise habits, techniques to deal with stress, and decisions on sleep time, all of which direct the trajectory of future health. There is a need for effective strategies that will encourage healthy lifestyle choices in young adults attending college.OBJECTIVE:This preliminary randomized controlled trial tested the effect of coaching and text messages (short message service, SMS) on self-selected health behaviors in the domains of diet, exercise, stress, and sleep. A second analysis measured the ripple effect of the intervention on health behaviors not specifically selected as a goal by participants.METHODS:Full-time students aged 18-30 years were recruited by word of mouth and campuswide advertisements (flyers, posters, mailings, university website) at a small university in western Pennsylvania from January to May 2015. Exclusions included pregnancy, eating disorders, chronic medical diagnoses, and prescription medications other than birth control. Of 60 participants, 30 were randomized to receive a single face-to-face meeting with a health coach to review results of behavioral questionnaires and to set a health behavior goal for the 8-week study period. The face-to-face meeting was followed by SMS text messages designed to encourage achievement of the behavioral goal. A total of 30 control subjects underwent the same health and behavioral assessments at intake and program end but did not receive coaching or SMS text messages.RESULTS:The texting app showed that 87.31% (2187/2505) of messages were viewed by intervention participants. Furthermore, 28 of the 30 intervention participants and all 30 control participants provided outcome data. Among intervention participants, 22 of 30 (73%) showed improvement in health behavior goal attainment, with the whole group (n=30) showing a mean improvement of 88% (95% CI 39-136). Mean improvement in any behavioral domains was not seen in the control group. Intervention participants also increased their exercise significantly compared with controls, regardless of their self-selected goal category. The increased exercise was paralleled by significantly lower fasting glucose levels.CONCLUSIONS:The health coaching session plus tailored SMS text messages improved self-selected health behaviors with a modest ripple effect to include unselected health behaviors.TRIAL REGISTRATION:Clinicaltrials.gov NCT02476604; https://clinicaltrials.gov/ct2/show/NCT02476604 (Archived by WebCite at http://www.webcitation.org/6qAAryS5t).

high. We intend to continue follow-up for the next two to five years, while looking for evidence of any long-term sequelae. The utility of endomyocardial biopsy after smallpox vaccination is uncertain. Given the inherent risks and low diagnostic yield of endomyocardial biopsy (1,4), as well as the high likelihood of full objective recovery after smallpox vaccine-associated myopericarditis (3), we would be remiss to recommend a potentially harmful procedure in all patients with depressed left ventricular function. Although there has been one case of eosinophilic myocarditis that improved shortly after receiving corticosteroids (5), this one case is insufficient to conclude that corticosteroids will always be beneficial, even when eosinophils are seen on biopsy. However, the possibility that corticosteroids may uniquely benefit patients with eosinophilic myocarditis does warrant continued evaluation. Therefore, although we support endomyocardial biopsy in patients with symptomatic moderate or worse left-ventricular dysfunction related temporally to smallpox vaccination, we caution that every case must be considered individually.

BACKGROUND: Self-efficacy, defined as confidence in the ability to carry out behavior to achieve a desired goal, is considered to be a prerequisite for behavior change. Self-efficacy correlates with cardiovascular health although optimal timing to incorporate self-efficacy strategies is not well established. We sought to study the effect of an empowerment approach implemented in the introductory phase of a multicomponent lifestyle intervention on cardiovascular health outcomes. DESIGN: Prospective intervention cohort study. METHODS: Patients in the Integrative Cardiac Health Project Registry, a prospective lifestyle change program for the prevention of cardiovascular disease were analyzed for behavioral changes by survey, at baseline and one year, in the domains of nutrition, exercise, stress management and sleep. Self-efficacy questionnaires were administered at baseline and after the empowerment intervention, at 8 weeks. RESULTS: Of 119 consecutive registry completers, 60 comprised a high self-efficacy group (scoring at or above the median of 36 points) and 59 the low self-efficacy group (scoring below median). Self-efficacy scores increased irrespective of baseline self-efficacy but the largest gains in self-efficacy occurred in patients who ranked in the lower half for self-efficacy at baseline. This lower self-efficacy group demonstrated behavioral gains that erased differences between the high and low self-efficacy groups. CONCLUSIONS: A boost to self-efficacy early in a lifestyle intervention program produces significant improvements in behavioral outcomes. Employing empowerment in an early phase may be a critical strategy to improve self-efficacy and lower risk in individuals vulnerable to cardiovascular disease.

Background: Metabolic dysfunction characterized by insulin resistance (IR) is an important risk factor for type-2 diabetes and coronary artery disease (CAD). The Lipoprotein Insulin Resistance (LP-IR) index, derived from measures of lipoprotein subclass particle concentration and size, is useful for assessing IR and identifying patients with increased diabetes/CAD risk. Hypothesis: This study addressed the hypothesis that lifestyle modification programs differing in scope and intensity both improve IR through changes in lipoprotein profiles. Methods: Patients with CAD or significant CAD risk factors participated in one of two clinical lifestyle interventions: 1) an intensive nonrandomized program with a strict vegetarian diet (n=90 subjects, 90 matched controls) or 2) a moderate randomized trial following a Mediterranean-style diet (n=89 participants, 58 controls). On-treatment and intention-to-treat analyses used regression modelling adjusted for CAD risk factors and lipid-lowering medication use to assess changes over one year in LP-IR, lipoprotein profiles, and CAD risk factors in intervention and control participants in both programs. Results: Participants in the intensive lifestyle intervention had poorer baseline cardiovascular health than patients in the moderate program. In the on-treatment analysis, both lifestyle interventions led to weight loss [-8.9% (95% CI: -10.3, -7.4), intensive program; -2.8% (95% CI: -3.8, -1.9), moderate program; adjusted p<0.001] and a decrease in the LP-IR index [-13.3% (95% CI: -18.2, -8.3), intensive; -8.8% (95% CI: -12.9, -4.7), moderate; adjusted p<0.01] compared to respective controls over one year. Of the six lipoprotein parameters comprising LP-IR, only large very-low-density lipoprotein (VLDL) particle concentrations decreased significantly in patients compared to controls in both programs [-26.3% (95% CI: -43.0, -9.6), intensive; -14.2% (95% CI: -27.4, -1.0), moderate; p<0.05]. Intention-to-treat analysis confirmed and strengthened the primary results. Discussion: In conclusion, moderate lifestyle modification following a Mediterranean diet is comparable to a stringent intervention with a vegetarian diet for improving IR defined by the LP-IR index. Significant reductions in large VLDL particles may drive improvement in IR irrespective of the magnitude of lifestyle changes.

: The Integrative Cardiac Health Project (ICHP) aims to lead the way in Cardiovascular Disease (CVD) Prevention by conducting novel research utilizing a Systems Biology / personalized medicine design to discover and develop practical, effective and preemptive integrative approaches in order to detect and combat CVD earlier before it affects the quality of life. ICHPs ultimate goal is to translate our evidenced-based research findings for application into clinical practice. A translational research approach will provide the ability to find novel disease markers, optimal prevention and holistic treatment approaches, and a unique venue for future research as the virtual laboratory for optimal comprehensive health prevention in the military beneficiary population. This research method also allow us to further hypothesize and define relationships between CVD, other cardio metabolic disease states and maladaptive behavior patterns unique to service members such as pre-diabetes, stress, overweight and sleep disorders with the aim of targeting these disorders in a pre-clinical phase. Using an integrative, interdisciplinary preventive health approach, ICHP has shown that an individuals cluster of CV risk factors can be effectively targeted and improved.

Metabolic dysfunction characterized by insulin resistance (IR) is an important risk factor for developing type 2 diabetes and coronary artery disease (CAD). The Lipoprotein Insulin Resistance (LP-IR) score, derived from measures of lipoprotein subclass particle concentration and size, is a new

Background: An important mechanism in improving health status in behavioral cardiovascular (CV) self-management programs is patient self-efficacy, or a patient’s belief in their ability to make lifestyle changes to reach healthy goals. Little is known on when the optimal time is to incorporate self-efficacy enhancing strategies. We examined the impact of a jumpstart self-efficacy approach in the introductory phase of a multicomponent intervention on CV health outcomes. Methods: Participants enrolled in a 12-month CV behavioral health intervention, part of a prospective registry, completed validated questionnaires focusing on the four domains of the program: nutrition (Rate-Your-Plate), exercise (minutes of continuous exercise per week), stress (Perceived Stress Scale), sleep (Pittsburgh Sleep Quality Index) and CV-relevant Self-Efficacy Questionnaire. Empowerment strategies comprised a comprehensive risk assessment report with detailed lifestyle recommendations on optimizing risk reduction and a multi-disciplinary educational workshop with interactive healthy food demonstration and stress management instruction. For the remainder of the program, patients received ongoing motivational health-coaching to achieve healthy goals in the four domains. Self-Efficacy Questionnaire was administered at baseline and after the workshop, at 6 weeks from baseline. All other measures at entry to and at 6-months of the program were assessed with paired t-tests. Results: Of 88 consecutive completers of the registry, 65 subjects (77%) had a family history of premature CV disease. These high risk subjects (36 men, age 57.4 ± 12.7 years, 42 white, 15 black, 8 other) showed clinically and statistically significant improvements in all four domains as well as improvement in subjective fatigue and self-efficacy for CVD behaviors. Conclusion: A comprehensive CV health intervention emphasizing empowerment strategies early in the sequence of the program improves self-efficacy leading to substantial behavioral improvements in CV health parameters. These findings are highly relevant particularly in high-risk individuals who are vulnerable to CV disease and may have the opportunity to make behavioral lifestyle modifications to lower their risk of overt disease.

ObjectiveTo examine relationships between weight loss through changes in lifestyle and peripheral blood gene expression profiles.MethodsA prospective nonrandomized trial was conducted over 1 year in participants undergoing intensive lifestyle modification to reverse or stabilize progression of coronary artery disease. Cardiovascular risk factors, inflammatory biomarkers, and gene expression as a function of weight loss were assessed in 89 lifestyle participants and 71 retrospectively matched controls undergoing usual care.ResultsSubstantial weight loss (-15.23.8%) in lifestyle participants (n=33) was associated with improvement in selected cardiovascular risk factors and significant changes in peripheral blood gene expression from pre- to post-intervention: 132 unique genes showed significant expression changes (false discovery rate corrected P-value <0.05 and fold-change 1.4). Altered molecular pathways were related to immune function and inflammatory responses involving endothelial activation. In contrast, participants losing minimal weight (-3.1 +/- 2.5%, n=32) showed only minor changes in cardiovascular risk factors and markers of inflammation and no changes in gene expression compared to non intervention controls after 1 year.ConclusionsWeight loss (10%) during lifestyle modification is associated with down-regulation of genetic pathways governing interactions between circulating immune cells and the vascular endothelium and may be required to successfully reduce CVD risk.

Background Although myocarditis/pericarditis (MP) has been identified as an adverse event following smallpox vaccine (SPX), the prospective incidence of this reaction and new onset cardiac symptoms, including possible subclinical injury, has not been prospectively defined. Purpose The study's primary objective was to determine the prospective incidence of new onset cardiac symptoms, clinical and possible subclinical MP in temporal association with immunization. Methods New onset cardiac symptoms, clinical MP and cardiac specific troponin T (cTnT) elevations following SPX (above individual baseline values) were measured in a multi-center prospective, active surveillance cohort study of healthy subjects receiving either smallpox vaccine or trivalent influenza vaccine (TIV). Results New onset chest pain, dyspnea, and/or palpitations occurred in 10.6% of SPX-vaccinees and 2.6% of TIV-vaccinees within 30 days of immunization (relative risk (RR) 4.0, 95% CI: 1.7-9.3). Among the 1081 SPX-vaccinees with complete follow-up, 4 Caucasian males were diagnosed with probable myocarditis and 1 female with suspected pericarditis. This indicates a post-SPX incidence rate more than 200-times higher than the pre-SPX background population surveillance rate of myocarditis/pericarditis (RR 214, 95% CI 65-558). Additionally, 31 SPX-vaccinees without specific cardiac symptoms were found to have over 2-fold increases in cTnT (>99th percentile) from baseline (pre-SPX) during the window of risk for clinical myocarditis/pericarditis and meeting a proposed case definition for possible subclinical myocarditis. This rate is 60-times higher than the incidence rate of overt clinical cases. No clinical or possible subclinical myocarditis cases were identified in the TIV-vaccinated group. Conclusions Passive surveillance significantly underestimates the true incidence of myocarditis/pericarditis after smallpox immunization. Evidence of subclinical transient cardiac muscle injury post-vaccinia immunization is a finding that requires further study to include long-term outcomes surveillance. Active safety surveillance is needed to identify adverse events that are not well understood or previously recognized.

Heart disease and related sequelae are a leading cause of death and healthcare expenditure throughout the world. Although many patients opt for surgical interventions, lifestyle modification programs focusing on nutrition and exercise have shown substantial health benefits and are becoming increasing popular. We conducted a year-long lifestyle modification program to mediate cardiovascular risk through traditional risk factors and to investigate how molecular changes, if present, may contribute to long-term risk reduction. Here we describe the lifestyle intervention, including clinical and molecular data collected, and provide details of the experimental methods and quality control parameters for the gene expression data generated from participants and non-intervention controls. Our findings suggest successful and sustained modulation of gene expression through healthy lifestyle changes may have beneficial effects on vascular health that cannot be discerned from traditional risk factor profiles. The data are deposited in the Gene Expression Omnibus, series GSE46097 and GSE66175.

Clinical guidelines for the care of obstructive sleep apnea (OSA) recommend evaluation of daytime sleepiness but do not specify evaluation of fatigue. We studied how subjects with and without OSA experience fatigue and sleepiness, examining the role of gender and race.

Background:Although family history (FH) is an independent predictor of cardiovascular disease (CVD) risk, traditional risk scores do not incorporate FH. Nurse practitioners routinely solicit FH but have no mechanism to incorporate the information into risk estimation. Underestimation of risk leaves clinicians misinformed and patients vulnerable to the CVD epidemic. Objective:We examined a systematic approach incorporating FH in CVD risk assessment, validating risk reclassification using carotid intima-media thickness (CIMT), a surrogate measure of atherosclerosis. Methods:Of 413 consecutive patients prospectively enrolled in the Integrative Cardiac Health Project Registry, a subgroup of 239 was low or intermediate risk by the Framingham Risk Score. A systematic approach for the assessment of FH was applied to this subgroup of the registry. A positive FH for premature CVD, defined as a first-degree relative having a CVD event before the age of 55 years in men and 65 years in women, conferred reclassification to high risk. Reclassification was validated with CIMT results. Results:Chart audits revealed adherence to the systematic approach for FH assessment in 100% of cases. This systematic approach identified 115 of 239 (48%) patients as high risk because of positive FH. Of the reclassified patients, 75% had evidence of subclinical atherosclerosis by CIMT versus 55% in the patients not reclassified, P < 0.001. Logistic regression identified positive FH for premature CVD (odds ratio, 2.6; P = 0.001) among all variables, as the most significant predictor of abnormal CIMT, thus increasing risk for CVD. Conclusions:The Integrative Cardiac Health Project systematic approach incorporating FH into risk stratification enhances CVD risk assessment by identifying previously unrecognized high-risk patients, reduces variability in practice, and appropriately targets more stringent therapeutic goals for prevention.