Background Post-stroke disability is common, costly, and projected to increase. Acute stroke treatments can substantially reduce post-stroke disability, but few patients take advantage of these cost-effective treatments. Practical, cost-efficient, and sustainable interventions to address underutilized acute stroke treatments are currently lacking. In this context, we present the Stroke Ready project, a stepped wedge design, multi-level intervention that combines implementation science and community-based participatory research approaches to increase acute stroke treatments in the predominately African American community of Flint, Michigan, USA. Methods Guided by the Tailored Implementation of Chronic Disease (TICD) framework, we begin with optimization of acute stroke care in emergency departments, with particular attention given to our safety-net hospital partners. Then, we move to a community-wide, multi-faceted, stroke preparedness intervention, with workshops led by peer educators, over 2 years. Measures of engagement of the safety-net hospital and the feasibility and sustainability of the implementation strategy as well as community intervention reach, dose delivered, and satisfaction will be collected. The primary outcome is acute stroke treatment rates, which includes both intravenous tissue plasminogen activator, and endovascular treatment. The co-secondary outcomes are intravenous tissue plasminogen activator treatment rates and the proportion of stroke patients who arrive by ambulance. Discussion If successful, Stroke Ready will increase acute stroke treatment rates through emergency department and community level interventions. The stepped wedge design and process evaluation will provide insight into how Stroke Ready works and where it might work best. By exploring the relative effectiveness of the emergency department optimization and the community intervention, we will inform hospitals and communities as they determine how best to use their resources to optimize acute stroke care. Trial registration ClinicalTrials.gov Trial Identifier NCT03645590 . Electronic supplementary material The online version of this article (10.1186/s13012-019-0869-3) contains supplementary material, which is available to authorized users.
Objective: To study the impact of a very-low-carbohydrate (VLC) diet for 16 weeks in overweight or obese women with polycystic ovary syndrome (PCOS). Design: Single-arm prospective pilot study. Setting: We recruited participants using medical records from an academic medical center. Patient(s): Twenty-nine overweight or obese women (body mass index, 25-50 kg/m 2 ) with PCOS. Intervention(s): We taught participants to follow a VLC diet and provided information about a variety of behavioral skills including mindfulness and positive affect using an online 16-week intervention. Main Outcome Measure(s): Changes in body weight, glycated hemoglobin, and PCOS-related quality of life. Result(s): The intervention led to positive health outcomes including decreases in percent weight (mean difference ¼ À7.67, SD ¼ 6.10) and glycated hemoglobin level (mean difference ¼ À0.21%, SD ¼ 0.27), an increase in sex hormone binding globulin level (mean difference ¼ 9.24 nmol/L, SD ¼ 16.34), and increases in PCOS-related quality of life measures, including menstrual predictability (mean difference ¼ 2.10, SD ¼ 2.76) and body hair (mean difference ¼ 1.14, SD ¼ 1.04). The low-density lipoprotein cholesterol level increased (mean difference ¼ 0.23 mmol/L, SD ¼ 0.49). Conclusion(s):The results suggest that a VLC dietary intervention has potential to promote both weight loss and glycemic control in overweight and obese adults with PCOS, two key components in the prevention of type 2 diabetes.
Acute stroke thrombolytics greatly reduce post-stroke disability, both in clinical trials and in clinical practice. 1-3 Too few patients, however, take advantage of these life-improving and cost-saving treatments. 4, 5 In fact, in the United States up to 7.5% of tissue plasminogen activator (tPA) eligible patients refuse this time limited stroke treatment, 6, 7 and even among stroke patients who receive tPA, up to 20% experience delayed treatment due to patient and family consent. 8 Currently in the United States, a recommended approach to tPA consent is shared decision making, which involves deliberative consideration of options, risks, benefits, and patient values. While shared decision making is highly valuable and appropriate in many medical decision making situations, we believe that full shared decision making is not well suited for the acute stroke scenario due to the lack of clinical equipoise regarding tPA administration, the time sensitive nature of this acute stroke treatment, and an inappropriate setting for in depth-discussions. tPA is approved by the United States Food and Drug Administration and the European Union, albeit with more restrictive eligibility criteria than the current guideline recommendations. 9 Current United States professional societies' recommendations on tPA administration vary in strength by specialty. For example, in the United States, Neurology and Neurosurgical societies strongly recommend tPA treatment, while Emergency Medicine societies are more tepid in their recommendations. The American Heart Association, with endorsements from American Association of Neurological Surgeons and Congress of Neurological Surgeons, gives tPA administration in the 3 hour window its strongest recommendation. 10 However, in 2015 the American College of Emergency Physicians'
PURPOSE Adults with a triple multimorbidity (hypertension, prediabetes or type 2 diabetes, and overweight or obesity), are at increased risk of serious health complications, but experts disagree on which dietary patterns and support strategies should be recommended. METHODSWe randomized 94 adults from southeast Michigan with this triple multimorbidity using a 2 × 2 diet-by-support factorial design, comparing a very low-carbohydrate (VLC) diet vs a Dietary Approaches to Stop Hypertension (DASH) diet, as well as comparing results with and without multicomponent extra support (mindful eating, positive emotion regulation, social support, and cooking). RESULTSUsing intention-to-treat analyses, compared with the DASH diet, the VLC diet led to greater improvement in estimated mean systolic blood pressure (-9.77 mm Hg vs -5.18 mm Hg; P = .046), greater improvement in glycated hemoglobin (-0.35% vs -0.14%; P = .034), and greater improvement in weight (-19.14 lb vs -10.34 lb; P = .0003). The addition of extra support did not have a statistically significant effect on outcomes.CONCLUSIONS For adults with hypertension, prediabetes or type 2 diabetes, and overweight or obesity, the VLC diet resulted in greater improvements in systolic blood pressure, glycemic control, and weight over a 4-month period compared with the DASH diet. These findings suggest that larger trials with longer follow-up are warranted to determine whether the VLC diet might be more beneficial for disease management than the DASH diet for these high-risk adults.
Background The Center for Disease Control and Prevention’s National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. Specifically, the NDPP teaches individuals to follow a low-fat, calorie-restricted diet and to engage in regular physical activity to achieve ≥ 5% body weight loss. Most NDPP participants, however, do not achieve this weight loss goal, and glycemic control remains largely unchanged. One promising opportunity to augment the NDPP’s weight loss and glycemic effectiveness may be to teach participants to follow a very low-carbohydrate diet (VLCD), which can directly reduce post-prandial glycemia and facilitate weight loss by reducing circulating insulin and enabling lipolysis. To date, there have been no high-quality, randomized controlled trials to test whether a VLCD can prevent progression to T2DM among individuals with prediabetes. The aim of this study is to test the effectiveness of a VLCD version the NDPP (VLC-NDPP) versus the standard NDPP. We hypothesize the VLC-NDPP will demonstrate greater improvements in weight loss and glycemic control. Methods We propose to conduct a 12-month, 1:1, randomized controlled trial that will assign 300 adults with overweight or obesity and prediabetes to either the NDPP or VLC-NDPP. The primary outcome will be glycemic control as measured by change in hemoglobin A1c (HbA1c) from baseline to 12 months. Secondary outcomes will include percent body weight change and changes in glycemic variability, inflammatory markers, lipids, and interim HbA1c. We will evaluate progression to T2DM and initiation of anti-hyperglycemic agents. We will conduct qualitative interviews among a purposive sample of participants to explore barriers to and facilitators of dietary adherence. The principal quantitative analysis will be intent-to-treat using hierarchical linear mixed effects models to assess differences over time. Discussion The NDPP is the dominant public health strategy for T2DM prevention. Changing the program’s dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program’s effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome. Trial registration NCT05235425. Registered February 11, 2022.
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