Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure.

INTRODUCTION: Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients' decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication. METHODS AND ANALYSIS: We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings. TRIAL REGISTRATION NUMBER: NCT04466865.

The effects of water and non-nutritive sweetened beverages on weight loss and weight maintenance: A randomized clinical trial.

OBJECTIVE: To evaluate the effects of water versus beverages sweetened with non-nutritive sweeteners (NNS) on body weight in subjects enrolled in a year-long behavioral weight loss treatment program. METHODS: The study used a randomized equivalence design with NNS or water beverages as the main factor in a trial among 303 weight-stable people with overweight and obesity. All participants participated in a weight loss program plus assignment to consume 24 ounces (710 ml) of water or NNS beverages daily for 1 year. RESULTS: NNS and water treatments were non-equivalent, with NNS treatment showing greater weight loss at the end of 1 year. At 1 year subjects receiving water had maintained a 2.45 ± 5.59 kg weight loss while those receiving NNS beverages maintained a loss of 6.21 ± 7.65 kg (P < 0.001 for difference). CONCLUSIONS: Water and NNS beverages were not equivalent for weight loss and maintenance during a 1-year behavioral treatment program. NNS beverages were superior for weight loss and weight maintenance in a population consisting of regular users of NNS beverages who either maintained or discontinued consumption of these beverages and consumed water during a structured weight loss program. These results suggest that NNS beverages can be an effective tool for weight loss and maintenance within the context of a weight management program.

The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program.

OBJECTIVE: To compare the efficacy of non-nutritive sweetened beverages (NNS) or water for weight loss during a 12-week behavioral weight loss treatment program. METHODS: An equivalence trial design with water or NNS beverages as the main factor in a prospective randomized trial among 303 men and women was employed. All participants participated in a behavioral weight loss treatment program. The results of the weight loss phase (12 weeks) of an ongoing trial (1 year) that is also evaluating the effects of these two treatments on weight loss maintenance were reported. RESULTS: The two treatments were not equivalent with the NNS beverage treatment group losing significantly more weight compared to the water group (5.95 kg versus 4.09 kg; P < 0.0001) after 12 weeks. Participants in the NNS beverage group reported significantly greater reductions in subjective feelings of hunger than those in the water group during 12 weeks. CONCLUSION: These results show that water is not superior to NNS beverages for weight loss during a comprehensive behavioral weight loss program.

Biomarker Profile Does Not Predict Weight Loss Success in Successful and Unsuccessful Diet-Reduced Obese Individuals: a Prospective Study.

BACKGROUND: Individuals attempting weight reduction have varying success when participating in the same intervention. Identifying physiological factors associated with greater weight loss could improve outcomes. METHODS: Sixty-one adults (BMI 27-30 kg/m2) participated in a 16-week group-based, cognitive-behavioral control weight loss program. Concentrations of 12 fasting hormones and cytokines related to adiposity, satiety/hunger, and inflammation were measured using the Milliplex human metabolic human panel before and after weight loss. Participants were grouped based on ≥8% (successful group, SG) or <8% weight loss (less successful group, LSG). RESULTS: The SG had 46 subjects (75.4%), while the LSG had 15 (24.6%).There were no differences in baseline sex distribution, age, weight, BMI, and body composition between groups. In the SG, baseline to the 16-week levels decreased significantly for c-peptide (1,030 versus 891 pg/mL, P = 0.002), insulin (665 versus 541 pg/mL, P = 0.001), and leptin (0.83 versus 0.58 ng/mL/kg fat, P < 0.001). None of the baseline analytes predicted greater weight loss. CONCLUSIONS: Successful weight loss was associated with changes in adiposity (less fat mass) and unfavorable hunger signals. No baseline biomarker profile was associated with weight loss success. Behavioral factors may have outweighed physiological signals for determining successful weight loss. This trial is registered with ClinicalTrials.gov NCT00429650.

Randomized controlled trial of Micro-Mobile Compression® on lactate clearance and subsequent exercise performance in elite male cyclists.

BACKGROUND: The purpose of this paper was to assess the feasibility of Micro-Mobile Compression® (MMC) on lactate clearance following exhaustive exercise and on subsequent exercise performance. METHODS: Elite male cyclists were randomized to MMC (n = 8) or passive recovery (control, n = 8). MMC is incorporated into a sandal that intermittently compresses the venous plexus during non-weight bearing to augment venous return. On day 1, subjects performed a graded exercise test on a cycle ergometer followed by 60 minutes of seated recovery, with or without MMC. Blood lactate concentration ([La(-)]) was measured during exercise and recovery. Subjects returned home for 3 more hours of seated recovery, with or without MMC. On days 2 and 3, subjects exercised to exhaustion in a fixed-load cycle ergometer test at 85% peak power and then repeated the day 1 post-exercise recovery procedures. Lactate clearance data after the time to exhaustion tests on days 2 and 3 were averaged to adjust for interday variation. RESULTS: On the day after MMC or control recovery, mean time to exhaustion was 15% longer (mean difference, 2.1 minutes) in the MMC group (P = 0.30). The standardized mean difference of MMC for time to exhaustion was 0.55, defined as a moderate treatment effect. Following the graded exercise test, area under the 60-minute lactate curve was nonsignificantly lower with MMC (3.2 ± 0.4 millimolar [mM]) versus control (3.5 ± 0.4 mM, P = 0.10) and times from end of exercise to 4mM and 2mM were 2.1 minutes (P = 0.58) and 7.2 minutes (P = 0.12) shorter, although neither achieved statistical significance. Following time to exhaustion testing, the area under the 60-minute lactate curve was lower with MMC (3.2 ± 0.2 mM) versus control (3.5 ± 0.2 mM, P = 0.02) and times from end of exercise to 4mM and 2mM were 4.4 minutes (P = 0.02) and 7.6 minutes (P < 0.01) faster. The standardized mean difference of MMC on most lactate clearance parameters was >0.8, defined as a large treatment effect. CONCLUSION: MMC yields large treatment effects on lactate clearance following high-intensity exercise and moderate treatment effects on subsequent exercise performance in elite male cyclists.

Comparative effects of low-carbohydrate high-protein versus low-fat diets on the kidney.

BACKGROUND AND OBJECTIVES: Concerns exist about deleterious renal effects of low-carbohydrate high-protein weight loss diets. This issue was addressed in a secondary analysis of a parallel randomized, controlled long-term trial. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Between 2003 and 2007, 307 obese adults without serious medical illnesses at three United States academic centers were randomly assigned to a low-carbohydrate high-protein or a low-fat weight-loss diet for 24 months. Main outcomes included renal filtration (GFR) indices (serum creatinine, cystatin C, creatinine clearance); 24-hour urinary volume; albumin; calcium excretion; and serum solutes at 3, 12, and 24 months. RESULTS: Compared with the low-fat diet, low-carbohydrate high-protein consumption was associated with minor reductions in serum creatinine (relative difference, -4.2%) and cystatin C (-8.4%) at 3 months and relative increases in creatinine clearance at 3 (15.8 ml/min) and 12 (20.8 ml/min) months; serum urea at 3 (14.4%), 12 (9.0%), and 24 (8.2%) months; and 24-hour urinary volume at 12 (438 ml) and 24 (268 ml) months. Urinary calcium excretion increased at 3 (36.1%) and 12 (35.7%) months without changes in bone density or clinical presentations of new kidney stones. CONCLUSIONS: In healthy obese individuals, a low-carbohydrate high-protein weight-loss diet over 2 years was not associated with noticeably harmful effects on GFR, albuminuria, or fluid and electrolyte balance compared with a low-fat diet. Further follow-up is needed to determine even longer-term effects on kidney function.

Relationship between treatment preference and weight loss in the context of a randomized controlled trial.

Randomized controlled trials (RCTs) are considered the gold standard used to assess the efficacy of treatment. While a well implemented RCT can produce an unbiased estimate of the relative difference between treatment groups, the generalizability of these findings may be limited. Specific threats to the external validity include treatment preference. The purposes of this study were to: (i) assess whether receiving one's treatment preference was associated with weight loss and retention and (ii) whether receiving one's treatment preference modified the relationship between the treatments and weight loss. Treatment preference was assessed in 250 subjects prior to but independent of randomization into either low-carbohydrate or low-fat diets. Treatment preference was a predictor of weight loss (P = 0.002) but not retention (P = 0.90). Participants who received their preference lost less weight (-7.7 kg, 95% confidence interval (CI): -9.3 to -6.1) than participants who did not receive their preference (-9.7 kg, 95% CI: -11.4 to -8.1) and participants who did not report a strong preference at baseline (-11.2 kg, 95% CI: -12.6 to -9.7) (P = 0.04 and P = 0.0004, respectively). Treatment preference did not modify the effect of the treatment on weight loss. Contrary to conceptual predictions, this study failed to identify an interaction between treatment preference and weight loss in the setting of a randomized trial. Until treatment preference effects are definitively ruled out in this domain, future studies might consider stratifying their randomization procedure by treatment preference rather than excluding participants with strong treatment preferences.

Change in food cravings, food preferences, and appetite during a low-carbohydrate and low-fat diet.

The study objective was to evaluate the effect of prescribing a low-carbohydrate diet (LCD) and a low-fat diet (LFD) on food cravings, food preferences, and appetite. Obese adults were randomly assigned to a LCD (n = 134) or a LFD (n = 136) for 2 years. Cravings for specific types of foods (sweets, high-fats, fast-food fats, and carbohydrates/starches); preferences for high-sugar, high-carbohydrate, and low-carbohydrate/high-protein foods; and appetite were measured during the trial and evaluated during this secondary analysis of trial data. Differences between the LCD and LFD on change in outcome variables were examined with mixed linear models. Compared to the LFD, the LCD had significantly larger decreases in cravings for carbohydrates/starches and preferences for high-carbohydrate and high-sugar foods. The LCD group reported being less bothered by hunger compared to the LFD group. Compared to the LCD group, the LFD group had significantly larger decreases in cravings for high-fat foods and preference for low-carbohydrate/high-protein foods. Men had larger decreases in appetite ratings compared to women. Prescription of diets that promoted restriction of specific types of foods resulted in decreased cravings and preferences for the foods that were targeted for restriction. The results also indicate that the LCD group was less bothered by hunger compared to the LFD group and that men had larger reductions in appetite compared to women.

Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial.

BACKGROUND: Previous studies comparing low-carbohydrate and low-fat diets have not included a comprehensive behavioral treatment, resulting in suboptimal weight loss. OBJECTIVE: To evaluate the effects of 2-year treatment with a low-carbohydrate or low-fat diet, each of which was combined with a comprehensive lifestyle modification program. DESIGN: Randomized parallel-group trial. (ClinicalTrials.gov registration number: NCT00143936) SETTING: 3 academic medical centers. PATIENTS: 307 participants with a mean age of 45.5 years (SD, 9.7 years) and mean body mass index of 36.1 kg/m(2) (SD, 3.5 kg/m(2)). INTERVENTION: A low-carbohydrate diet, which consisted of limited carbohydrate intake (20 g/d for 3 months) in the form of low-glycemic index vegetables with unrestricted consumption of fat and protein. After 3 months, participants in the low-carbohydrate diet group increased their carbohydrate intake (5 g/d per wk) until a stable and desired weight was achieved. A low-fat diet consisted of limited energy intake (1200 to 1800 kcal/d;

A randomized trial of a low-carbohydrate diet for obesity.

BACKGROUND: Despite the popularity of the low-carbohydrate, high-protein, high-fat (Atkins) diet, no randomized, controlled trials have evaluated its efficacy. METHODS: We conducted a one-year, multicenter, controlled trial involving 63 obese men and women who were randomly assigned to either a low-carbohydrate, high-protein, high-fat diet or a low-calorie, high-carbohydrate, low-fat (conventional) diet. Professional contact was minimal to replicate the approach used by most dieters. RESULTS: Subjects on the low-carbohydrate diet had lost more weight than subjects on the conventional diet at 3 months (mean [+/-SD], -6.8+/-5.0 vs. -2.7+/-3.7 percent of body weight; P=0.001) and 6 months (-7.0+/-6.5 vs. -3.2+/-5.6 percent of body weight, P=0.02), but the difference at 12 months was not significant (-4.4+/-6.7 vs. -2.5+/-6.3 percent of body weight, P=0.26). After three months, no significant differences were found between the groups in total or low-density lipoprotein cholesterol concentrations. The increase in high-density lipoprotein cholesterol concentrations and the decrease in triglyceride concentrations were greater among subjects on the low-carbohydrate diet than among those on the conventional diet throughout most of the study. Both diets significantly decreased diastolic blood pressure and the insulin response to an oral glucose load. CONCLUSIONS: The low-carbohydrate diet produced a greater weight loss (absolute difference, approximately 4 percent) than did the conventional diet for the first six months, but the differences were not significant at one year. The low-carbohydrate diet was associated with a greater improvement in some risk factors for coronary heart disease. Adherence was poor and attrition was high in both groups. Longer and larger studies are required to determine the long-term safety and efficacy of low-carbohydrate, high-protein, high-fat diets.