The CHANGE trial: no superiority of lifestyle coaching plus care coordination plus treatment as usual compared to treatment as usual alone in reducing risk of cardiovascular disease in adults with schizophrenia spectrum disorders and abdominal obesity

Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel‐group, superiority, multi‐centre trial with blinded outcome assessment, testing the efficacy of an intervention aimed to improve cardiovascular risk profile and hereby potentially reduce mortality. A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual (N=138), or care coordination plus treatment as usual (N=142), or treatment as usual alone (N=148). The primary outcome was 10‐year risk of cardiovascular disease assessed post‐treatment and standardized to age 60. At follow‐up, the mean 10‐year risk of cardiovascular disease was 8.4 ± 6.7% in the group receiving lifestyle coaching, 8.5 ± 7.5% in the care coordination group, and 8.0 ± 6.5% in the treatment as usual group (p=0.41). We found no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal obesity.     

Lifestyle intervention in obese patients with type 2 diabetes: impact of the patient's educational background

Objective: To determine whether people with different educational backgrounds respond differently to a lifestyle intervention program for obese patients with type 2 diabetes. Research Methods and Procedures: The study consisted of a 12‐month randomized controlled trial of 147 health plan members with type 2 diabetes who were overweight or obese (BMI ≥ 27 kg/m²). Participants were randomized to lifestyle case management or usual care. Case management (CM) involved group and individual education, support, and referral by registered dietitians. Usual care (UC) participants received educational material. Both groups received ongoing primary care. A post hoc analysis was performed, evaluating the impact of education level on intervention group differences with respect to change in weight and waist circumference. Results: There was a significant education by group interaction for both changes in weight (p = 0.02) and waist circumference (p = 0.01) during the study period. Contrary to expectations, CM participants with less formal education had greater risk reductions compared with more educated participants. Models predicted that, by 12 months, those with less education in the UC group gained 1.71 kg more in weight and 3.67 cm more in waist circumference than those with greater education. However, by 12 months, those in the CM group with less education lost a model‐predicted 3.30 kg more in weight and 4.95 cm more in waist circumference than those with more formal education. Discussion: People with varied educational backgrounds may respond differently to a lifestyle intervention for weight management and diabetes control.     

The effects of Hartcoach, a life style intervention provided by telephone on the reduction of coronary risk factors: a randomised trial

ABSTRACT: BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide. Secondary prevention is essential, but participation rates for cardiac rehabilitation are low. Furthermore, current programmes do not accomplish that patients with CVD change their lifestyle in a way that their individual risk factors for recurrent events decrease, therefore more effective interventions are needed. In this study, the effectiveness of the Hartcoach-programme, a telephonic secondary prevention program focussing on self management, is studied. Methods/design A multicenter, randomised parallel-group study is being conducted. Participants are 400 patients with acute myocardial infarction (STEMI, NSTEMI,) and patients with chronic or unstable angina pectoris (IAP). Patients are recruited through the participating hospitals and randomly assigned to the experimental group (Hartcoach-programme plus usual care) or the control group (usual care). The Hartcoach-programme consists of a period of six months during which the coach contacts the patient every four to six weeks by telephone. Coaches train patients to take responsibility for the achievement and maintenance of the defined target levels for their particular individual modifiable risk factors. Target levels and treatment goals are agreed by the nurse and patient together. Data collection is blinded and occurs at baseline and after 26 weeks (post-intervention). Primary outcome is change in cardiovascular risk factors (cholesterol, body mass index, waist circumference, blood pressure, physical activity and diet). Secondary outcomes include chances in glucose, HbA1c, medication adherence, selfmanagement and quality of life. DISCUSSION: This study evaluates the effects of the Hartcoach-programme on the reduction of individual risk factors of patients with CVDs. Patients who are not invited to follow a hospital based rehabilitation programme or patients who are unable to adhere to such a programme, may be reached by this home based Hartcoach-programme. If positive results are found, the implementation of the Hartcoach-programme will be extended, having implications for the management of many people with CVD. Trial registration NTR2388.     

Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial

Background:Although cardiovascular disease may be partially preventable through dietary and lifestyle-based interventions, few individuals at risk receive intensive dietary and lifestyle counselling. We performed a randomized controlled trial to evaluate the effectiveness of naturopathic care in reducing the risk of cardiovascular disease.Methods:We performed a multisite randomized controlled trial of enhanced usual care (usual care plus biometric measurement; control) compared with enhanced usual care plus naturopathic care (hereafter called naturopathic care). Postal workers aged 25–65 years in Toronto, Vancouver and Edmonton, Canada, with an increased risk of cardiovascular disease were invited to participate. Participants in both groups received care by their family physicians. Those in the naturopathic group also received individualized care (health promotion counselling, nutritional medicine or dietary supplementation) at 7 preset times in work-site clinics by licensed naturopathic doctors. The body weight, waist circumference, lipid profile, fasting glucose levels and blood pressure of participants in both groups were measured 3 times during a 1-year period. Our primary outcomes were the 10-year risk of having a cardiovascular event (based on the Framingham risk algorithm) and the prevalence of metabolic syndrome (based on the Adult Treatment Panel III diagnostic criteria).Results:Of 246 participants randomly assigned to a study group, 207 completed the study. The characteristics of participants in both groups were similar at baseline. Compared with participants in the control group, at 52 weeks those in the naturopathic group had a reduced adjusted 10-year cardiovascular risk (control: 10.81%; naturopathic group: 7.74%; risk reduction −3.07% [95% confidence interval (CI) −4.35% to −1.78%], p < 0.001) and a lower adjusted frequency of metabolic syndrome (control group: 48.48%; naturopathic care: 31.58%; risk reduction −16.90% [95% CI −29.55% to −4.25%], p = 0.002).Interpretation:Our findings support the hypothesis that the addition of naturopathic care to enhanced usual care may reduce the risk of cardiovascular disease among those at high risk. Trial registration: ClinicalTrials.gov, no. NCT0071879.Cardiovascular disease is the second leading cause of death in Canada.¹ Observational studies, including a large international case–control study, have shown that several modifiable behavioural factors contribute to the risk of cardiovascular disease.² Metabolic syndrome, a cluster of modifiable risk factors for atherosclerotic cardiovascular disease, is strongly associated with increased risk of cardiovascular-related mortality.^3,4 Guidelines by the American Heart Association and the United States Preventive Services Task Force recommend lifestyle interventions as an important part of cardiovascular disease prevention.^5,6 Although the importance of lifestyle intervention is widely recognized, few individuals with, or at risk of, cardiovascular disease receive intensive dietary and lifestyle counselling.^7,8A variety of health care practitioners routinely deliver diet and health promotion advice to patients at risk of cardiovascular disease. Naturopathic doctors in North America are trained and regulated practitioners who emphasize this form of self-directed care. Several retrospective analyses have suggested that patients at risk of cardiovascular disease receive lifestyle counselling routinely as part of naturopathic care.^9–11 However, no rigorous studies have examined the effectiveness of these approaches. To evaluate the effectiveness of representative naturopathic approaches to reducing the risk of cardiovascular disease, we conducted a randomized clinical trial of a multimodality nutritional and physical activity intervention in a workplace setting.     

Waist circumference action levels in the identification of cardiovascular risk factors: prevalence study in a random sample.

OBJECTIVE--To determine the frequency of cardiovascular risk factors in people categorised by previously defined "action levels" of waist circumference. DESIGN--Prevalence study in a random population sample. SETTING--Netherlands. SUBJECTS--2183 men and 2698 women aged 20-59 years selected at random from the civil registry of Amsterdam and Maastricht. MAIN OUTCOME MEASURES--Waist circumference, waist to hip ratio, body mass index (weight (kg)/height (m2)), total plasma cholesterol concentration, high density lipoprotein cholesterol concentration, blood pressure, age, and lifestyle. RESULTS--A waist circumference exceeding 94 cm in men and 80 cm in women correctly identified subjects with body mass index of > or = 25 and waist to hip ratios > or = 0.95 in men and > or = 0.80 in women with a sensitivity and specificity of > or = 96%. Men and women with at least one cardiovascular risk factor (total cholesterol > or = 6.5 mmol/l, high density lipoprotein cholesterol < or = 0.9 mmol/l, systolic blood pressure > or = 160 mm Hg, diastolic blood pressure > or = 95 mm Hg) were identified with sensitivities of 57% and 67% and specificities of 72% and 62% respectively. Compared with those with waist measurements below action levels, age and lifestyle adjusted odds ratios for having at least one risk factor were 2.2 (95% confidence interval 1.8 to 2.8) in men with a waist measurement of 94-102 cm and 1.6 (1.3 to 2.1) in women with a waist measurement of 80-88 cm. In men and women with larger waist measurements these age and lifestyle adjusted odds ratios were 4.6 (3.5 to 6.0) and 2.6 (2.0 to 3.2) respectively. CONCLUSIONS--Larger waist circumference identifies people at increased cardiovascular risks.     

Defining Health‐Related Obesity in Prepubertal Children

Objective: The purpose of this study was to develop percentage of fat and waist circumference cut‐points in prepubertal children with the intention of defining obesity associated with cardiovascular disease (CVD) risk. Research Methods and Procedures: A cross‐sectional analysis of 87 prepubertal children aged 4 to 11 years was used. Percentage of body fat was determined by DXA. Waist circumference was measured to the nearest millimeter. Receiver Operating Characteristic analyses of percentage of fat and waist circumference were used to develop cut‐points for individuals with adverse levels of CVD risk factors. Results: The risk factors selected for analyses (i.e., fasting insulin, high‐density lipoprotein cholesterol, low‐density lipoprotein cholesterol, triglycerides, and total cholesterol/high‐density lipoprotein cholesterol) were significantly related to percentage of body fat and waist circumference. Likelihood ratios were used to identify percentage of fat and waist circumference cut‐points associated with adverse cardiovascular risk profiles. Two cut‐points, an upper cut‐point of 33% body fat and a lower cut‐point of 20% body fat, were derived. Waist circumference cut‐points indicative of adverse and normal risk‐factor profiles were 71 cm and 61 cm, respectively. Discussion: The data indicate that children with ≥33% body fat and children with a waist circumference ≥71 cm were more likely to possess an adverse CVD risk‐factor profile than a normal risk‐factor profile. The likelihood of children with <20% body fat or a waist circumference <61 cm possessing an adverse CVD risk‐factor profile as opposed to a normal risk‐factor profile was small. The cut‐points describe an adequate health‐related definition of childhood obesity.     

Different anthropometric adiposity measures and their association with cardiovascular disease risk factors: a meta-analysis

Objectives

To investigate which anthropometric adiposity measure has the strongest association with cardiovascular disease (CVD) risk factors in Caucasian men and women without a history of CVD.

Design

Systematic review and meta-analysis.

Methods

We searched databases for studies reporting correlations between anthropometric adiposity measures and CVD risk factors in Caucasian subjects without a history of CVD. Body mass index (BMI), waist circumference, waist-to-hip ratio, waist-to-height ratio and body fat percentage were considered the anthropometric adiposity measures. Primary CVD risk factors were: systolic blood pressure, diastolic blood pressure, high density lipoprotein (HDL) cholesterol, triglycerides and fasting glucose. Two independent reviewers performed abstract, full text and data selection.

Results

Twenty articles were included describing 21,618 males and 24,139 females. Waist circumference had the strongest correlation with all CVD risk factors for both men and women, except for HDL and LDL in men. When comparing BMI with waist circumference, the latter showed significantly better correlations to CVD risk factors, except for diastolic blood pressure in women and HDL and total cholesterol in men.

Conclusions

We recommend the use of waist circumference in clinical and research studies above other anthropometric adiposity measures, especially compared with BMI, when evaluating CVD risk factors.     

Minimal versus umbilical waist circumference measures as indicators of cardiovascular disease risk

Objective: Measures of central obesity are strongly correlated with cardiovascular disease (CVD) risk. Although waist circumference (WC) is a commonly used measure of central obesity, there is no standard measurement location. We examined two WC locations to determine which was more highly correlated with CVD risk factors and metabolic syndrome (MS). Research Methods and Procedures: WC measures were taken on 266 sedentary, overweight men and women 45 to 60 years old. Intravenous glucose tolerance tests, fasting plasma lipid analysis, and computed tomography scans were conducted. Correlational analyses followed by the Test for Equal Correlations determined whether one WC measure better correlated with the cardiovascular risk factors. Results: In women, minimal waist had higher correlation coefficients than umbilical waist for all eight variables presented. High‐density lipoprotein‐cholesterol, low‐density lipoprotein particle size, and MS score were significantly correlated with minimal waist, but not umbilical waist. For high‐density lipoprotein size and insulin sensitivity, minimal waist was a better correlate, although the difference between waist measures only approached statistical significance (p < 0.06). In men, minimal waist had a higher correlation coefficient than umbilical waist for insulin sensitivity, fasting insulin, and visceral adipose tissue. Additionally, minimal waist was significantly correlated with MS in men and umbilical waist was not. For both genders, minimal waist was more highly correlated with visceral adipose tissue than umbilical waist. Discussion: For every metabolic variable presented, minimal WC was more highly correlated with CVD risk than was umbilical WC in women. The data for women indicate that WC location is important when determining CVD risk. In men, minimal waist was better, although the data were less compelling.     

Disease-modifying antirheumatic drugs are associated with a reduced risk for cardiovascular disease in patients with rheumatoid arthritis: a case control study

Rheumatoid arthritis (RA) is characterized by inflammation and an increased risk for cardiovascular disease (CVD). This study investigates possible associations between CVD and the use of conventional disease-modifying antirheumatic drugs (DMARDs) in RA. Using a case control design, 613 RA patients (5,649 patient-years) were studied, 72 with CVD and 541 without CVD. Data on RA, CVD and drug treatment were evaluated from time of RA diagnosis up to the first cardiovascular event or the end of the follow-up period. The dataset was categorized according to DMARD use: sulfasalazine (SSZ), hydroxychloroquine (HCQ) or methotrexate (MTX). Odds ratios (ORs) for CVD, corrected for age, gender, smoking and RA duration, were calculated per DMARD group. Patients who never used SSZ, HCQ or MTX were used as a reference group. MTX treatment was associated with a significant CVD risk reduction, with ORs (95% CI): 'MTX only', 0.16 (0.04 to 0.66); 'MTX and SSZ ever', 0.20 (0.08 to 0.51); and 'MTX, SSZ and HCQ ever', 0.20 (0.08 to 0.54). The risk reductions remained significant after additional correction for the presence of rheumatoid factor and erosions. After correction for hypertension, diabetes and hypercholesterolemia, 'MTX or SSZ ever' and 'MTX, SSZ and HCQ ever' showed significant CVD risk reduction. Rheumatoid factor positivity and erosions both increased CVD risk, with ORs of 2.04 (1.02 to 4.07) and 2.36 (0.92 to 6.08), respectively. MTX and, to a lesser extent, SSZ were associated with significantly lower CVD risk compared to RA patients who never used SSZ, HCQ or MTX. We hypothesize that DMARD use, in particular MTX use, results in powerful suppression of inflammation, thereby reducing the development of atherosclerosis and subsequently clinically overt CVD.     

A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. METHODS: This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control).Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice.orControl group: Standard GP care, with referral to secondary care as required, but no access to ICCD.Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (<=7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients. DISCUSSION: Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].     

Body fat measured by a near-infrared interactance device as a predictor of cardiovascular events: the FINRISK'92 cohort

We evaluated how body fat percentage, measured by a portable near-infrared interactance (NIR) device predicts cardiovascular (CVD), coronary heart disease (CHD), and ischemic stroke events in a prospective population-based survey. The study population consisted of 2,842 men and 3,196 women, who participated in the FINRISK'92 survey. Obesity was assessed with BMI, waist circumference, and waist-to-hip ratio (WHR) and body fat percentage measured with an NIR. Mean length of follow-up was 9 years and 3 months. In Cox proportional hazards regression analyses for men, BMI, waist circumference, and WHR as well as body fat percentage were predictors of a CVD event when adjusted for age and for major risk factors. Hazard ratio (HR) per 1 s.d. was 1.27 (95% confidence interval: 1.10-1.48) for body fat percentage, 1.30 (1.16-1.46) for BMI, and 1.31 (1.16-1.50) for waist circumference. Among women, the body fat lost its predictive power in a fully adjusted model. Body fat percentage, BMI, waist circumference, and WHR were predictors of a CHD event both among men and women, whereas body fat percentage did not predict ischemic stroke among either gender. We observed that body fat percentage measured by an NIR device was a significant predictor of CVD and CHD events among men and women, but in our population-based survey, it did not provide any additional predictive power over and above the simpler measures, such as BMI or WHR.     

Clustering of Major Cardiovascular Risk Factors and the Association with Unhealthy Lifestyles in the Chinese Adult Population

Background

Previous studies indicated that lifestyle-related cardiovascular risk factors tend to be clustered in certain individuals. However, population-based studies, especially from developing countries with substantial economic heterogeneity, are extremely limited. Our study provides updated data on the clustering of cardiovascular risk factors, as well as the impact of lifestyle on those factors in China.

Methods

A representative sample of adult population in China was obtained using a multistage, stratified sampling method. We investigated the clustering of four cardiovascular disease (CVD) risk factors (defined as two or more of the following: hypertension, diabetes, dyslipidemia and overweight) and their association with unhealthy lifestyles (habitual drinking, physical inactivity, chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) and a low modified Dietary Approaches to Stop Hypertension (DASH) score).

Results

Among the 46,683 participants enrolled in this study, only 31.1% were free of any pre-defined CVD risk factor. A total of 20,292 subjects had clustering of CVD risk factors, and 83.5% of them were younger than 65 years old. The adjusted prevalence of CVD risk factor clustering was 36.2%, and the prevalence was higher among males than among females (37.9% vs. 34.5%). Habitual drinking, physical inactivity, and chronic use of NSAIDs were positively associated with the clustering of CVD risk factors, with ORs of 1.60 (95% confidence interval [CI] 1.40 to1.85), 1.20 (95%CI 1.11 to 1.30) and 2.17 (95%CI 1.84 to 2.55), respectively. The modified DASH score was inversely associated with the clustering of CVD risk factors, with an OR of 0.73 (95%CI 0.67 to 0.78) for those with modified DASH scores in the top tertile. The lifestyle risk factors were more prominent among participants with low socioeconomic status.

Conclusion

Clustering of CVD risk factors was common in China. Lifestyle modification might be an effective strategy to control CVD risk factors.     

Effectiveness of community-based comprehensive healthy lifestyle promotion on cardiovascular disease risk factors in a rural Vietnamese population: a quasi-experimental study

ABSTRACT: BACKGROUND: Health promotion is a key component for primary prevention of cardiovascular disease (CVD). This study evaluated the impact of healthy lifestyle promotion campaigns on CVD risk factors (CVDRF) in the general population in the context of a community-based programme on hypertension management. METHODS: A quasi-experimental intervention study was carried out in two rural communes of Vietnam from 2006 to 2009. In the intervention commune, a hypertensive-targeted management programme integrated with a community-targeted health promotion was initiated, while no new programme, apart from conventional healthcare services, was provided in the reference commune. Health promotion campaigns focused on smoking cessation, reducing alcohol consumption, encouraging physical activity and reducing salty diets. Repeated cross-sectional surveys in local adult population aged 25 years and over were undertaken to assess changes in blood pressure (BP) and behavioural CVDRFs (smoking, alcohol consumption, physical inactivity and salty diet) in both communes before and after the 3-year intervention. RESULTS: Overall 4,650 adults above 25 years old were surveyed, in four randomly independent samples covering both communes at baseline and after the 3-year intervention. Although physical inactivity and obesity increased over time in the intervention commune, there was a significant reduction in systolic and diastolic BP (3.3 and 4.7 mmHg in women versus 3.0 and 4.6 mmHg in men respectively) in the general population at the intervention commune. Health promotion reduced levels of salty diets but had insignificant impact on the prevalence of daily smoking or heavy alcohol consumption. CONCLUSION: Community-targeted healthy lifestyle promotion can significantly improve some CVDRFs in the general population in a rural area over a relatively short time span. Limited effects on a context-bound CVDRF like smoking suggested that higher intensity of intervention, a supportive environment or a gender approach are required to maximize the effectiveness and maintain the sustainability of the health intervention.     

Genes, fat intake, and cardiovascular disease risk factors in the Quebec Family Study

Objective: The aim of this study was to assess gene‐diet interaction effects on cardiovascular disease (CVD) risk factors (waist circumference, plasma triacylglycerol, high‐density lipoprotein‐cholesterol and fasting glucose concentrations, and diastolic and systolic blood pressure) in the Quebec Family Study cohort. Design: Sixty‐four polymorphisms from 45 candidate genes were studied in 645 subjects. Dietary fat intake was obtained from a 3‐day weighted food record. Results: We observed 18 significant interactions at a p value ≤ 0.01. Among them, the Pro12Ala polymorphism in peroxisome proliferator‐activated receptor γ, alone or in interaction with fat intake, significantly modulated waist circumference (p = 0.0005 for both effects). Additionally, the apolipoprotein E genotype in interaction with fat intake was significantly associated with diastolic and systolic blood pressure (p = 0.01 and p = 0.001, respectively). The ghrelin Leu72Met polymorphism also interacted with dietary fat in its relation to waist circumference and triacylglycerol concentrations (p = 0.0004 and p = 0.005). Discussion: These results suggest that several alleles at candidate genes interact with dietary fat intake to modulate well‐known CVD risk factors. The identification of gene‐diet interaction effects is likely to provide useful information concerning the etiology of CVD.     

Association of type 2 diabetes susceptibility loci with one-year weight loss in the look AHEAD clinical trial

The importance of lifestyle intervention for the prevention and treatment of type 2 diabetes (T2D) has been underscored by the limited benefit of pharmacologic therapies. We sought to determine whether genetic variants that contribute to T2D risk modify the response of weight and waist circumference to an intensive lifestyle intervention (ILI) in patients with obesity and T2D. Look AHEAD (Action for Health in Diabetes) is a randomized clinical trial comparing an ILI with a control condition on the risk of cardiovascular disease in overweight adults with T2D. We analyzed 28 single-nucleotide polymorphisms (SNPs) at/near 17 T2D-susceptibility genes in 3,903 consented participants. We genetically characterized the cohort by assessing whether T2D-susceptibility loci were overrepresented compared with a nondiabetic community-based cohort (N = 1,016). We evaluated the association of individual variants and a composite genetic risk score (GRS) with anthropometric traits at baseline and after 1-year of intervention. Look AHEAD subjects carried more T2D-susceptibility alleles than the control population. At baseline, TCF7L2 risk alleles and the highest GRS were associated with lower BMI and waist circumference. Nominally significant genotype-by-intervention interactions were detected for 1-year change in waist circumference with JAZF1, MTNR1B, and IRS1, and BMI with JAZF1. Highest GRS was associated with a greater reduction in waist circumference at year 1, although the variance in change attributable to the GRS was small. This study shows that the genetic burden associated with T2D risk does not undermine the effect of lifestyle intervention and suggests the existence of additional genomic regions, distinct from the T2D-susceptibility loci, which may enhance or mitigate weight loss.     

Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial

ABSTRACT: BACKGROUND: Decreasing salt consumption can prevent cardiovascular diseases (CVD). Practically, it is difficult to promote people's awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health. Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular disease. METHODS: This is a cluster randomized trial. A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand, will be studied with informed consent. A health center recruiting 100 participants is a cluster, the unit of randomization. Eight clusters will be randomized into intervention and control arms and followed up for 1 year. Within the intervention clusters the following will be undertaken: (1) salt content in the daily diet will be measured and shown to study participants; (2) 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; (3) a dietician will assist small group health education classes in cooking meals with less salt. The primary outcome is blood pressure change at the 1-year follow-up. Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake, incidence of CVD events and CVD death. The intention-to-treat analysis will be followed.Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up. Clinical CVD events and deaths will be analyzed by time-event analysis. Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally. Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model (SEM). Multilevel regression analyses will be applied. Finally, the cost effectiveness of the intervention will be analyzed. DISCUSSION: This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system. Dietary salt reduction will be applied as a prioritized, community level intervention for the prevention of CVD in a developing country.Trial registrationISRCTN39416277.     

Multiple cardiovascular disease risk factors in Canadian adults. Canadian Heart Health Surveys Research Group.

OBJECTIVE: To estimate the prevalence and distribution of the coexistence of major cardiovascular disease (CVD) risk factors among Canadian adults. DESIGN: Population-based cross-sectional surveys. SETTING: Nine Canadian provinces, from 1986 to 1990. PARTICIPANTS: A probability sample of 26,293 men and women, aged 18 to 74 years, was selected from provincial health insurance registries. For 20,582 of these participants, at least two blood pressure (BP) measurements were taken using a standardized technique. At a subsequent visit to a clinic, two additional BP readings, anthropometric measurements and a blood specimen for plasma lipid analysis were obtained. OUTCOME MEASURES: The percentage distribution of subjects by number of major risk factors (smoking, high BP and elevated blood cholesterol level) and by concomitant factors (body mass index [BMI], ratio of waist to hip circumference [WHR], physical activity, diabetes, awareness of CVD risk factors and education). MAIN RESULTS: Sixty-four percent of men and 63% of women had one or more of the major risk factors. Prevalence increased with age to reach 80% in men and 89% in women aged 65 to 74 years. Prevalence of two or three risk factors was highest among men in the 45-54 age group (34%) and in women in the 65-74 age group (37%). The most common associations were between smoking and high blood cholesterol level (10%) and between high BP and high blood cholesterol level (8%). Prevalence of high BP and elevated blood cholesterol, alone or in combination, increased with BMI and WHR. Smoking, elevated blood cholesterol, BMI and prevalence of one or more risk factors increased with lower level of education. Less than 48% of participants mentioned any single major risk factor as a cause of heart disease. Awareness was lowest in the group with fewest years of education. CONCLUSION: The findings of this study call for an approach to reduce CVD that stresses collaboration of the different health sectors to reach both the population as a whole and the individuals at high risk.     

Waist Circumference as a Cardiovascular and Metabolic Risk in Japanese Patients With Type 2 Diabetes

Excess waist circumference (WC) is a frequently used indicator of abdominal obesity and/or cardiovascular disease (CVD) risk. Nonetheless, search of the literature revealed no prospective studies on the association between WC and CVD events in diabetic patients. In this study, the clinical significance and implications of WC as a cardiovascular and metabolic risk indicator was prospectively investigated in Japanese patients with type 2 diabetes. For this purpose, baseline data on WC, hypertension, and dyslipidemia were collected and subsequent CVD (coronary heart disease and stroke) events during the following 8 years were studied in 1,424 Japanese type 2 diabetic patients, and the cross ‐ sectional/longitudinal associations between WC and CVD risk factors/events were analyzed. Mean WC levels were significantly increased according to the number of coexisting risk factors. However, no significant difference in mean WC between subgroups with and without CVD events was noted, and excess WC alone was not predictive of subsequent CVD events either in male or female subjects even after adjustment for age, smoking, hypertension, and dyslipidemia. In female patients, excess WC (≥80 cm) was predictive of CVD events only with the coexistence of hypertension. In Japanese diabetic patients, excess WC alone, although a good marker for clustering of CVD risk factors, did not raise the risk of CVD events unless accompanied by hypertension in female patients. Further investigations are necessary before WC as a risk factor can be utilized in clinical settings for the management of diabetes in this population.     

Effects of a lifestyle intervention on adiposity and fitness in overweight or low fit preschoolers (Ballabeina)

Objective:

Overweight (OW) and low fit children represent cardiovascular high‐risk groups. A multidimensional school‐based lifestyle intervention performed in 652 preschoolers reduced skinfold thickness and waist circumference, and improved fitness, but did not affect BMI. The objective of this study is to examine whether the intervention was equally effective in OW (≥90th national percentile) and/or low fit (lowest sex‐ and age‐adjusted quartile of aerobic fitness) children compared to their normal weight and normal fit counterparts.

Design and Methods:

Cluster randomized controlled single blinded trial, conducted in 2008/09 in 40 randomly selected preschool classes in Switzerland. The intervention included a playful physical activity program and lessons on nutrition, media use and sleeps. Primary outcomes were BMI and aerobic fitness; secondary outcomes included sum of four skinfolds, waist circumference and motor agility. Modification of intervention effects by BMI‐group and fitness‐group was tested by interaction terms.

Results:

Compared to their counterparts, OW children (n = 130) had more beneficial effects on waist circumference (p for interaction = 0.001) and low fit children (n = 154) more beneficial effects on all adiposity outcomes (p for interaction ≤0.03). The intervention effects on both fitness outcomes were not modified by BMI‐ or fitness‐group (all p for interaction ≥0.2). Average intervention effect sizes for BMI were ?0.12, ?0.05, ?0.26 and ?0.02 kg/m² and for aerobic fitness were 0.40, 0.30, 0.12 and 0.36 stages for OW, normal weight, low fit and normal fit children, respectively. Conclusions: This multidimensional intervention was equally and for some adiposity measures even more effective in high‐risk preschoolers and represents a promising option for these children.