Different Lifestyle Interventions in Adults From Underserved Communities: The FAMILIA Trial.

BACKGROUND: The current trends of unhealthy lifestyle behaviors in underserved communities are disturbing. Thus, effective health promotion strategies constitute an unmet need. OBJECTIVES: The purpose of this study was to assess the impact of 2 different lifestyle interventions on parents/caregivers of children attending preschools in a socioeconomically disadvantaged community. METHODS: The FAMILIA (Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health) study is a cluster-randomized trial involving 15 Head Start preschools in Harlem, New York. Schools, and their children's parents/caregivers, were randomized to receive either an "individual-focused" or "peer-to-peer-based" lifestyle intervention program for 12 months or control. The primary outcome was the change from baseline to 12 months in a composite health score related to blood pressure, exercise, weight, alimentation, and tobacco (Fuster-BEWAT Score [FBS]), ranging from 0 to 15 (ideal health = 15). To assess the sustainability of the intervention, this study evaluated the change of FBS at 24 months. Main pre-specified secondary outcomes included changes in FBS subcomponents and the effect of the knowledge of presence of atherosclerosis as assessed by bilateral carotid/femoral vascular ultrasound. Mixed-effects models were used to test for intervention effects. RESULTS: A total of 635 parents/caregivers were enrolled: mean age 38 ± 11 years, 83% women, 57% Hispanic/Latino, 31% African American, and a baseline FBS of 9.3 ± 2.4 points. The mean within-group change in FBS from baseline to 12 months was ∼0.20 points in all groups, with no overall between-group differences. However, high-adherence participants to the intervention exhibited a greater change in FBS than their low-adherence counterparts: 0.30 points (95% confidence interval: 0.03 to 0.57; p = 0.027) versus 0.00 points (95% confidence interval: -0.43 to 0.43; p = 1.0), respectively. Furthermore, the knowledge by the participant of the presence of atherosclerosis significantly boosted the intervention effects. Similar results were sustained at 24 months. CONCLUSIONS: Although overall significant differences were not observed between intervention and control groups, the FAMILIA trial highlights that high adherence rates to lifestyle interventions may improve health outcomes. It also suggests a potential contributory role of the presentation of atherosclerosis pictures, providing helpful information to improve future lifestyle interventions in adults.

Rationale and Design of Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA).

BACKGROUND: The 2020 American Heart Association Impact Goal aims to improve cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular disease and stroke by 20%. A large step toward this goal would be to better understand and take advantage of the significant intersection between behavior and biology across the entire life-span. In the proposed FAMILIA studies, we aim to directly address this major knowledge and clinical health gap by implementing an integrated family-centric health promotion intervention and focusing on the intersection of environment and behavior, while understanding the genetic and biologic basis of cardiovascular disease. METHODS: We plan to recruit 600 preschool children and their 600 parents or caregivers from 12-15 Head Start schools in Harlem, NY, and perform a 2:1 (2 intervention/1 control) cluster randomization of the schools. The preschool children will receive our intensive 37-hour educational program as the intervention for 4 months. For the adults, those in the "intervention" group will be randomly assigned to 1 of 2 intervention programs: an "individual-focused" or "peer-to-peer based." The primary outcome in children will be a composite score of knowledge (K), attitudes (A), habits (H), related to body mass index Z score (B), exercise (E), and alimentation (A) (KAH-BEA), using questionnaires and anthropometric measurements. For adults, the primary outcome will be a composite score for behaviors/outcomes related to blood pressure, exercise, weight, alimentation (diet) and tobacco (smoking; Fuster-BEWAT score). Saliva will be collected from the children for SNP genotyping, and blood will be collected from adults for RNA sequencing to identify network models and predictors of primary prevention outcomes. CONCLUSION: The FAMILIA studies seek to demonstrate that targeting a younger age group (3-5 years) and using a family-based approach may be a critical strategy in promoting cardiovascular health across the life-span.

Three-dimensional volumetric assessment of coronary artery calcification in patients with stable coronary artery disease by OCT.

AIMS: There is a lack of a reliable technique to quantify coronary artery calcification (CAC). Hence, we used optical coherence tomography (OCT) to quantitate three-dimensional CAC volume to examine its association with plaque characteristics. METHODS AND RESULTS: A total of 250 patients with stable angina undergoing OCT imaging before PCI were included. CAC volume was calculated from every frame of the culprit lesion and divided into tertiles (low, intermediate and high). Quantitative calcium characteristics were assessed in 107 patients who underwent both OCT and IVUS. Increase in CAC volume was associated with reduced lipid volume index, lipid length and number of lipid plaques. Diabetes and LDL cholesterol predicted less coronary calcification whereas age and prior MI predicted increased CAC after adjusting for all clinical factors. Lipid volume index (ρ=-0.001 [-0.003 to -0.00003]; p=0.04) and mean calcium depth (ρ=-0.02 [-0.02 to -0.01]; p=0.000) were inversely related to CAC volume after adjusting for all OCT characteristics, whereas cap thickness increased with increase in CAC volume (ρ=0.01 [0.002-0.03]; p=0.02) only in unadjusted analysis. Regression analysis demonstrated a significant correlation between calcium length (ρ=0.83; p<0.001) and calcium arc (ρ=0.86; p<0.001) measured by IVUS and OCT. CONCLUSIONS: Target lesions with high CAC volume are characterised by reduced plaque lipid content and calcium closer to the luminal border. Fibrous cap thickness increased with increase in calcium volume.

The relationships between cardiovascular disease and diabetes: focus on pathogenesis.

There is a looming global epidemic of obesity and diabetes. Of all the end-organ effects caused by diabetes, the cardiovascular system is particularly susceptible to the biologic perturbations caused by this disease, and many patients may die from diabetes-related cardiovascular complications. Substantial progress has been made in understanding the pathobiology of the diabetic vasculature and heart. Clinical studies have illuminated the optimal way to treat patients with cardiovascular manifestations of this disease. This article reviews these aspects of diabetes and the cardiovascular system, broadly classified into diabetic vascular disease, diabetic cardiomyopathy, and the clinical management of the diabetic cardiovascular disease patient.

Female gender and mortality after percutaneous coronary intervention: results from a large registry.

OBJECTIVES: To investigate if previously reported gender-based outcome disparities following percutaneous coronary intervention (PCI) are applicable in a large and racially-diverse cohort in the drug eluting stent (DES) era. BACKGROUND: It is generally believed that women suffer inferior outcomes compared to men after PCI. However, various strategies have evolved that may have mitigated this imbalance, including improved medical therapy, attention to risk-factors, and procedural advances of PCI including DES. METHODS: We identified 13,752 patients (4,761 female, 34.6%) with complete follow-up data who underwent de novo lesion PCI from 04/2003 to 04/2009. Relevant data were extracted from an IRB-approved registry. RESULTS: Compared to males, females were significantly older (69.0 vs. 64.8 years) and more frequently from a minority or non-Caucasian background. Females smoked less, but more were hypertensive and/or diabetic. Women had higher HDL, but also higher LDL cholesterol levels. More women presented with an unstable coronary syndrome and required left anterior descending artery PCI. While unadjusted post-PCI mortality rates were higher in females versus males (30 days, 1.3 vs. 0.8%, P = 0.009; 1 year, 6.1 vs. 4.8%, P = 0.001; 3 year, 10.4 vs. 8.4%, P < 0.0001), multivariable regression analyses failed to identify female gender as an independent predictor of mortality. Propensity-adjusted modeling confirmed that females were not at intrinsically higher risk for mortality after PCI. CONCLUSIONS: Females undergoing PCI exhibit more comorbidities and adverse prognostic factors than males. However, risk-adjusted analyses identified that gender is not an independent predictor of mortality after PCI in the DES era.