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Effects of a 2-Year Primary Care Lifestyle Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial.
Höchsmann, C, Dorling, JL, Martin, CK, Newton, RL, Apolzan, JW, Myers, CA, Denstel, KD, Mire, EF, Johnson, WD, Zhang, D, et al
Circulation. 2021;(12):1202-1214
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Abstract
BACKGROUND Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months. METHODS The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24. RESULTS As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P<0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P<0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P=0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P<0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity (z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P<0.01) and -0.21 (95% CI, -0.36 to -0.06; P=0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point. CONCLUSIONS A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.
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Population Approaches Targeting Metabolic Syndrome Focusing on Japanese Trials.
Nishizawa, H, Shimomura, I
Nutrients. 2019;(6)
Abstract
The clinical importance of assessment of metabolic syndrome lies in the selection of individuals with multiple risk factors based on visceral fat accumulation, and helping them to reduce visceral fat. Behavioral modification by population approach is important, which adds support to the personal approach. The complexity of visceral fat accumulation requires multicomponent and multilevel intervention. Preparation of food and physical environments could be useful strategies for city planners. Furthermore, actions on various frameworks, including organizational, community, and policy levels, have been recently reported. There are universal public health screening programs and post-screening health educational systems in Japan, and diseases management programs in Germany. Understanding one's own health status is important for motivation for lifestyle modification. The U.S. Preventive Services Task Force recommends that primary care practitioners screen all adults for obesity and offer behavioral interventions and intensive counseling. Established evidence-based guidelines for behavioral counseling are needed within the primary care setting.
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Risk Factors for Chronic Diseases and Multimorbidity in a Primary Care Context of Central Argentina: A Web-Based Interactive and Cross-Sectional Study.
Olivares, DE, Chambi, FR, Chañi, EM, Craig, WJ, Pacheco, SO, Pacheco, FJ
International journal of environmental research and public health. 2017;(3)
Abstract
Global health agencies estimate an increase of chronic diseases in South America. Nevertheless, few studies have investigated chronic diseases and their risk factors in the perspective of multimorbidity. This research aimed to identify these aspects in a primary health care setting of central Argentina. The Pan America version of the STEP wise approach surveillance (STEPS) instrument of the World Health Organization was applied to 1044 participants, 365 men and 679 women, with a mean age of 43 years. High prevalence of overweight (33.5%), obesity (35.2%), central obesity (54%), dyslipidemia (43.5%), metabolic syndrome (21.1%), low intake of fruit and vegetables (91.8%), low levels of physical activity (71.5%), risky alcohol consumption (28%), and smoking (22.5%) were detected. Hypertension and diabetes were the most prevalent chronic conditions and the total prevalence of multimorbidity was 33.1%, with 2, 3, 4, 5 and 6 chronic conditions found in 19.9%, 9.1%, 2.6%, 1.1% and 0.4% of the population, respectively. Multimorbidity affected 6.4% of the young, 31.7% of the adults, and 60.6% of the elderly, and was more prevalent among women, and in participants with lower levels of education. Having multimorbidity was significantly associated with obesity, central obesity, and higher concentrations of total blood cholesterol, low-density lipoprotein cholesterol, triglycerides, and glucose. A website was made available to the participants in order to share the experimental results and health-promoting information.
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Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial.
Rosas, LG, Lv, N, Xiao, L, Lewis, MA, Zavella, P, Kramer, MK, Luna, V, Ma, J
Contemporary clinical trials. 2016;:30-40
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Abstract
UNLABELLED Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diabetes Prevention Program intervention in a randomized controlled trial with overweight/obese Latino adults who have metabolic syndrome and/or pre-diabetes. Eligible, consenting patients (n=186) from a large community-based multispecialty group practice in Northern California will be randomly assigned to receive the culturally-adapted intervention or usual care. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guided the planned evaluations. The primary aim is to determine the effectiveness of the intervention (the "E" in RE-AIM). We hypothesize that the intervention will lead to a greater mean reduction in weight at 24months (primary endpoint) vs. usual care. Secondary outcomes will include measures of cardiometabolic risk factors (e.g., blood pressure), psychosocial well-being (e.g., health-related quality of life), and behavior change (e.g., physical activity). The secondary aim is to evaluate the other RE-AIM dimensions using mixed methods: reach (e.g., participation rate of the target population), adoption (e.g., participating clinic and provider characteristics), implementation (e.g., intervention fidelity), and maintenance (e.g., sustainability in the practice setting). These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for primary care that would support the millions of Latino adults who experience a disproportionate burden of diabetes. TRIAL REGISTRATION NCT02459691.
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Yoga's effect on inflammatory biomarkers and metabolic risk factors in a high risk population - a controlled trial in primary care.
Wolff, M, Memon, AA, Chalmers, JP, Sundquist, K, Midlöv, P
BMC cardiovascular disorders. 2015;:91
Abstract
BACKGROUND Yoga can reduce blood pressure and has also been suggested to reduce inflammatory biomarkers and metabolic risk factors for cardiovascular diseases (CVDs). We aimed to assess the benefit of two yoga interventions on inflammatory biomarkers and metabolic risk factors in a high risk population in primary care. METHODS Adult patients from a health care center in Sweden, with diagnosed hypertension, were invited to undergo a baseline check at the health care center. Baseline check included standardized blood pressure measurement, BMI and weight circumference measurements, blood sampling (hs-CRP, IL-6, FP-glucose, HbA1c, cholesterol, TG, LDL and HDL) and a questionnaire on self-rated quality of life (WHOQOL-BREF). There were three groups: 1) yoga class with yoga instructor; 2) yoga at home; and 3) a control group. In total, 83 patients were included and matched at the group level for systolic blood pressure. A majority of the patients (92 %) were on antihypertensive medication, which they were requested not to change during the study. After 12 weeks of intervention, the assessments were performed again. RESULTS We recorded no evidence that yoga altered inflammatory biomarkers or metabolic risk factors in our study population. A total of 49 participants (59 %) met the criteria for metabolic syndrome. CONCLUSION The yoga interventions performed in our study did not affect inflammatory biomarkers or metabolic risk factors associated with CVD in the study population of primary care patients with hypertension. Further randomized trials are needed to elucidate the effects of yoga on CVD risk factors in this particular group. TRAIL REGISTRATION NCT01302535 , February 22, 2011.
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Obesity, cardiovascular disease and type 2 diabetes in people with a mental illness: a need for primary health care.
Stanley, SH, Laugharne, JD
Australian journal of primary health. 2012;(3):258-64
Abstract
People with a mental illness show a growing incidence of obesity, and higher rates of metabolic syndrome when compared with the general population. This paper reviews research on obesity, cardiovascular disease and type 2 diabetes, with the aim of directing clinical attention towards the improvement of patient physical health. A systematic search of cross-discipline databases and journals provided peer-reviewed research for analysis, and national statistics allowed for the investigation of differences in rates of occurrence between people experiencing a mental illness and the general population. Treatment effects via psychotropic medications and lifestyle factors such as poor diet and low levels of exercise suggest that ongoing monitoring is necessary to prevent major physical disorders in people experiencing a mental illness. To aid clinicians, a comprehensive set of clinical guidelines have been developed for the physical assessment and ongoing monitoring of mental health patients.
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Treatment of co-morbid mental illness in primary care: how to minimize weight gain, diabetes, and metabolic syndrome.
Gibson, M, Carek, PJ, Sullivan, B
International journal of psychiatry in medicine. 2011;(2):127-42
Abstract
In patients with mental illness the increased risk from cardiovascular disease appears to be related to the increased incidence of obesity, hypertension, and diabetes mellitus. Barriers to the medical care in this patient population include diminished adherence to treatment and preventative recommendations, lack of willingness to engage in self-care activities, decreased access to affordable medical care, underestimation of risk by physicians, and adverse effects of commonly prescribed psychiatric medications. When managing patients with mental illness it is necessary to estimate the patient's metabolic and cardiovascular risk, monitor BMI, waist circumference, fasting glucose, and lipid profile regularly, evaluate psychiatric medications metabolic risk, and choose less "metabolically threatening" drugs. The promotion of healthy lifestyle choices among persons with serious mental illness is essential not only as part of their recovery, but as an integral part of preventing metabolic changes and weight gain linked to their illness and medication side effects. In patients with mental illness and co-morbid diabetes, metabolic syndrome, and obesity, psychiatrist and primary care clinicians should collaborate to establish a plan for healthy lifestyle habits (diet and activity regimen), encourage weight loss, and follow-up regularly using multispecialty teams to improve management.
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Non-Alcoholic Fatty Liver Disease (NAFLD): new challenge for general practitioners and important burden for health authorities?
Ahmed, MH, Abu, EO, Byrne, CD
Primary care diabetes. 2010;(3):129-37
Abstract
Non-alcoholic fatty liver disease (NAFLD) is the most common cause of hepatic dysfunction encountered in general practice. A large proportion of individuals with type 2 diabetes and the metabolic syndrome develop NAFLD. NAFLD is associated with severe insulin resistance and increased risk of cardiovascular disease and can progress to non-alcoholic steato-hepatitis, liver cirrhosis and cancer. Currently the only known effective treatments for NAFLD are lifestyle changes including stable weight loss and a diet low in calories. General practitioners will increasingly play a key role in dealing with this evolving but serious epidemic of NAFLD and associated metabolic complications. However, success will depend on the appropriate systems and mechanisms being in place in primary care and the proper motivation, support and education of the patient. This review provides the primary care physician with: (a) a step-by step guide of how to identify NAFLD, (b) information to exclude common other causes of liver fat accumulation and (c) additional insight into relationships between NAFLD and other conditions such as obesity, cardiovascular disease and type 2 diabetes.
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Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial.
Ma, J, King, AC, Wilson, SR, Xiao, L, Stafford, RS
BMC family practice. 2009;:71
Abstract
BACKGROUND Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings. DESIGN E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided alpha level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined. DISCUSSION This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.
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Treatment of bipolar disorders and metabolic syndrome: implications for primary care.
Bell, PF, McKenna, JP, Roscoe, BM
Postgraduate medicine. 2009;(5):140-4
Abstract
Recognition of the prevalence of mood disorders and increased availability of medication options have led to calls for treating bipolar disorders in the primary care setting. Second-generation antipsychotic medications (SGAs) were initially lauded for treating bipolar disorders because of their efficacy and perceived safety relative to first-generation antipsychotic medications. Metabolic syndrome is a constellation of risk factors for cardiovascular disease and type 2 diabetes mellitus, which may emerge when treating bipolar disorders with SGAs. We conducted a search of the research literature examining the association between different SGAs and metabolic syndrome. Based on our review, we offer guidelines for monitoring patient status regarding metabolic syndrome and for providing interventions to promote healthy diet and exercise.