William S. Yancy

A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol.

OBJECTIVE This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C. METHOD From 2007 to 2010, 255 outpatients with LDL-C>76 mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11 months. RESULTS Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference = 2.3 mg/dL, 95% CI = -3.6, 8.3, p = 0.44), nor did the odds of meeting goal LDL-C (OR = 0.95, 95% CI = 0.6, 1.7; p = 0.87). Intakes of calories (p = 0.03), total fat (p = 0.02), and saturated fat (p = 0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p = 0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR = 1.2, 95% CI = 1.0, 1.5, p = 0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups. CONCLUSION This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors.

A Pilot Trial of a Low-Carbohydrate, Ketogenic Diet in Patients with Type 2 Diabetes

THE ETIOLOGY OF HYPERINSULINISM, insulin resistance, and type 2 diabetes mellitus is probably multi-factorial and as yet undetermined. It is known, however, that these hallmarks of the metabolic syndrome are highly associated with obesity.1 It is also known that treatment of obesity in patients with these disorders can result in lower insulin levels plus improvements in insulin sensitivity, glycemia, hypertension, and dyslipidemia, which constitute the metabolic syndrome.2–5 Despite the multiple benefits, patients have extreme difficulty achieving and maintaining weight loss. American Diabetic Association (ADA) diet recommendations for type 2 diabetic patients include reduction of fat (especially saturated fats) and cholesterol intake combined with a relatively high carbohydrate intake.6 The aim of the “diabetic diet” is to reduce hyperlipidemia, a risk factor for heart disease.1 However, prospective studies of this diet are not convincing in regard to prevention of cardiac events,7 and this type of diet has been shown to increase triglycerides, postprandial blood glucose, and insulin levels as well as lower HDL cholesterol.8–11 In contrast, two recent randomized trials examining a low-carbohydrate, ketogenic diet (LCKD) demonstrated improvements in the above parameters, and one gave indication that the LCKD may be more effective than a low-fat diet for glycemic control in the sub-group of diabetics in the study.12,13 The purpose of this pilot study was to evaluate the efficacy, safety, and metabolic effects of a low-carbohydrate, ketogenic diet (LCKD) in overweight type 2 diabetic patients over 16 weeks.

Clinical Use of a Carbohydrate-Restricted Diet to Treat the Dyslipidemia of the Metabolic Syndrome

BACKGROUND The metabolic syndrome is characterized by an atherogenic dyslipidemia identifiable using lipoprotein subclass analysis. This study assesses the effect of a carbohydrate-restricted diet on the dyslipidemia of the metabolic syndrome in a clinical setting. METHODS This is a retrospective chart review of patients attending a preventive medicine clinic using lipoprotein subclass analysis (by NMR spectroscopy) to identify the atherogenic dyslipidemia. If present, patients were counseled to begin a carbohydrate-restricted diet (< 20 g/day). Patients already on statin therapy were included only if the medication dose was not changed. The outcomes were changes in body weight, fasting serum lipid profiles and serum lipoprotein subclasses. RESULTS Of 122 patients identified, 80 patients had complete pre- and post-treatment data. The mean (+/-SD) age was 66 +/- 9 years, baseline weight was 85 +/- 12 kg, BMI was 28.1 +/- 3.6, 73% were male, 99% were Caucasian. Sixty-five percent were taking statin medication. Carbohydrate-restriction led to a 13% reduction in total cholesterol, 16% reduction in LDL cholesterol, 38% reduction in triglycerides, and a 13% increase in HDL cholesterol (all p values < 0.001). Carbohydrate-restriction also led to a reduction in LDL particle concentration of 28%, a reduction in small LDL of 82%, a reduction of large VLDL of 62%, and an increase in large HDL of 30% (all p values < 0.001). CONCLUSIONS A carbohydrate-restricted diet recommendation led to improvements in lipid profiles and lipoprotein subclass traits of the metabolic syndrome in a clinical outpatient setting, and should be considered as a treatment for the metabolic syndrome.

Age and sex differences in prospective effects of health goals and motivations on daily leisure-time physical activity.

OBJECTIVE To examine relationships between health goals, types of motivation for those goals, and daily leisure-time physical activity (LTPA), and whether these relationships differ by age or sex. METHODS From 2005 to 2008, 710 participants in and around Berlin, Germany provided life goals and motivational attributes of those goals at baseline, then reported LTPA daily for 25 days. RESULTS Having (vs. not having) a goal of physical health predicted higher odds of engaging in LTPA for younger but not older participants (under age 30; OR=1.26, p=0.048), and was not related to duration of LTPA episodes. Effect of intrinsic motivation for the health goal differed by sex: for females, higher intrinsic motivation predicted higher odds of LTPA (OR=1.19, p=0.001), but was not related to duration. For males, higher intrinsic motivation predicted lower LTPA odds marginally (OR=0.70, p=0.054) but predicted longer duration (estimate=18.27 min, p<0.001). More approach motivation for the health goal predicted longer duration of LTPA episodes (0.67 min, p=0.022). CONCLUSIONS One size does not fit all in LTPA intervention design. Future research should identify the mechanisms by which health goals and motivations affect health behavior.

Glycemic load, exercise, and monitoring blood glucose (GEM): A paradigm shift in the treatment of type 2 diabetes mellitus

AIMS This preliminary RCT investigated whether an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activities guided by systematic self-monitoring of blood glucose (GEM) could improve metabolic control of adults with type 2 diabetes mellitus, without compromising other physiological parameters. METHODS Forty-seven adults (mean age 55.3 years) who were diagnosed with type 2 diabetes mellitus for less than 5 years (mean 2.1 years), had HbA1c ≥ 7% (mean 8.4%) and were not taking blood glucose lowering medications, were randomized to routine care or five 1-h instructional sessions of GEM. Assessments at baseline and 6 months included a physical exam, metabolic and lipid panels, and psychological questionnaires. RESULTS The GEM intervention led to significant improvements in HbA1c (decreasing from 8.4 to 7.4% [69-57 mmol/mol] compared with 8.3 to 8.3% [68-68 mmol/mol] for routine care; Interaction p<.01) and psychological functioning without compromising other physiological parameters. CONCLUSIONS Consistent with a patient-centered approach, GEM appears to be an effective lifestyle modification option for adults recently diagnosed with type 2 diabetes mellitus.

Patient self-efficacy and spouse perception of spousal support are associated with lower patient weight: Baseline results from a spousal support behavioral intervention

Obesity and related chronic illnesses are leading causes of death and excessive health care costs, necessitating identification of factors that can help patients achieve and maintain healthy weight. Greater self-efficacy and perceived spousal support in patients have been associated with successful weight management. The current study also assesses self-efficacy and perceived support in spouses and whether these factors are related to patient weight. At baseline of a spousal support trial, patients and spouses (N = 255 couples) each completed measures of self-efficacy and spousal support for their own exercise and healthy eating behaviors. We fit a multivariable regression model to examine the relationship between these factors and patient weight. Patients were 95% males and 65% Whites, with average age of 61 years (SD = 12) and weight of 212 lbs (SD = 42). Spouses were 64% Whites, with average age of 59 years (SD = 12). Factors associated with lower patient weight were older patient age (estimate = −0.8 lbs, p < .01), normal blood pressure (estimate = −17.6 lbs, p < .01), higher patient self-efficacy for eating healthy (estimate = −3.8 lbs, p = .02), and spouse greater perceived support for eating healthy (estimate = −10.0 lbs, p = .03). Future research should explore the causal pathways between perceived support and health outcomes to establish whether patient support behaviors could be a point of intervention for weight management.

Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial.

BACKGROUND Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. METHODS Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m2) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. CONCLUSIONS Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes.

Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial

Background/objectiveFinancial incentives can improve initial weight loss; we examined whether financial incentives can improve weight loss maintenance.Subjects/methodsParticipants aged 30–80 years who lost at least 5 kg during the first 4–6 months in a nationally available commercial weight loss program were recruited via the internet into a three-arm randomized trial of two types of financial incentives versus active control during months 1–6 (Phase I) followed by passive monitoring during months 7–12 (Phase II). Interventions were daily self-weighing and text messaging feedback alone (control) or combined with a lottery-based incentive or a direct incentive. The primary outcome was weight change 6 months after initial weight loss. Secondary outcomes included weight change 12 months after initial weight loss (6 months after cessation of maintenance intervention), and self-reported physical activity and eating behaviors.ResultsOf 191 participants randomized, the mean age was 49.0 (SD = 10.5) years and weight loss prior to randomization was 11.4 (4.7) kg; 92% were women and 89% were White. Mean weight changes during the next 6 months (Phase I) were: lottery −3.0 (5.8) kg; direct −2.8 (5.8) kg; and control −1.4 (5.8) kg (all pairwise comparisons p > 0.1). Weight changes through the end of 12 months post-weight loss (Phase II) were: lottery −1.8 (10.5) kg; direct −0.7 (10.7) kg; and control −0.3 (9.4) kg (all pairwise comparisons p > 0.1). The percentages of participants who maintained their weight loss (defined as gaining ≤1.36 kg) were: lottery 79%, direct 76%, and control 67% at 6 months and lottery 66%, direct 62%, and control 59% at 12 months (all pairwise comparisons p > 0.1). At 6 and 12 months after initial weight loss, changes in self-reported physical activity or eating behaviors did not differ across arms.ConclusionsCompared with the active control of daily texting based on daily home weighing, lottery-based and direct monetary incentives provided no additional benefit for weight loss maintenance.

Implementing a low-carbohydrate, ketogenic diet to manage type 2 diabetes mellitus

ABSTRACT Introduction: Type 2 diabetes mellitus (T2DM) has reached epidemic proportions in the modern world. For individuals affected by obesity-related T2DM, clinical studies have shown that carbohydrate restriction and weight loss can improve hyperglycemia, obesity, and T2DM. Areas covered: Reducing carbohydrate intake to a certain level, typically below 50 g per day, leads to increased ketogenesis in order to provide fuel for the body. Such low-carbohydrate, ketogenic diets were employed to treat obesity and diabetes in the 19th and early 20th centuries. Recent clinical research has reinvigorated the use of the ketogenic diet for individuals with obesity and diabetes. Although characterized by chronic hyperglycemia, the underlying cause of T2DM is hyperinsulinemia and insulin resistance, typically as a result of increased energy intake leading to obesity. The ketogenic diet substantially reduces the glycemic response that results from dietary carbohydrate as well as improves the underlying insulin resistance. This review combines a literature search of the published science and practical guidance based on clinical experience. Expert commentary: While the current treatment of T2DM emphasizes drug treatment and a higher carbohydrate diet, the ketogenic diet is an effective alternative that relies less on medication, and may even be a preferable option when medications are not available.