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Background: Observed associations of high-protein diets with changes in insulin resistance are inconclusive.Objectives: We aimed to assess associations of changes in both reported and estimated protein (PRep; PEst) and energy intake (EIRep; EIEst) with changes in HOMA-IR, glycated hemoglobin (HbA1c), and BMI (in kg/m2), in 1822 decreasing to 833 adults (week 156) with overweight and prediabetes, during the 3-y PREVIEW (PREVention of diabetes through lifestyle intervention and population studies In Europe and around the World) study on weight-loss maintenance. Eating behavior and measurement errors (MEs) of dietary intake were assessed. Thus, observational post hoc analyses were applied.Methods: Associations of changes in EIEst, EIRep, PEst, and PRep with changes in HOMA-IR, HbA1c, and BMI were determined by linear mixed-model analysis in 2 arms [high-protein-low-glycemic-index (GI) diet and moderate-protein-moderate-GI diet] of the PREVIEW study. EIEst was derived from energy requirement: total energy expenditure = basal metabolic rate × physical activity level; PEst from urinary nitrogen, and urea. MEs were calculated as [(EIEst - EIRep)/EIEst] × 100% and [(PRep - PEst)/PEst] × 100%. Eating behavior was determined using the Three Factor Eating Questionnaire, examining cognitive dietary restraint, disinhibition, and hunger.Results: Increases in PEst and PRep and decreases in EIEst and EIRep were associated with decreases in BMI, but not independently with decreases in HOMA-IR. Increases in PEst and PRep were associated with decreases in HbA1c. PRep and EIRep showed larger changes and stronger associations than PEst and EIEst. Mean ± SD MEs of EIRep and PRep were 38% ± 9% and 14% ± 4%, respectively; ME changes in EIRep and En% PRep were positively associated with changes in BMI and cognitive dietary restraint and inversely with disinhibition and hunger.Conclusions: During weight-loss maintenance in adults with prediabetes, increase in protein intake and decrease in energy intake were not associated with decrease in HOMA-IR beyond associations with decrease in BMI. Increases in PEst and PRep were associated with decrease in HbA1c.This trial was registered at clinicaltrials.gov as NCT01777893.

Aims/hypothesis Lifestyle interventions are the first-line treatment option for body weight and cardiometabolic health management. However, whether age groups or women and men respond differently to lifestyle interventions is under debate. We aimed to examine age- and sex-specific effects of a low-energy diet (LED) followed by a long-term lifestyle intervention on body weight, body composition and cardiometabolic health markers in adults with prediabetes (i.e. impaired fasting glucose and/or impaired glucose tolerance). Methods This observational study used longitudinal data from 2223 overweight participants with prediabetes in the multicentre diabetes prevention study PREVIEW. The participants underwent a LED-induced rapid weight loss (WL) period followed by a 3 year lifestyle-based weight maintenance (WM) intervention. Changes in outcomes of interest in prespecified age (younger: 25–45 years; middle-aged: 46–54 years; older: 55–70 years) or sex (women and men) groups were compared. Results In total, 783 younger, 319 middle-aged and 1121 older adults and 1503 women and 720 men were included in the analysis. In the available case and complete case analyses, multivariable-adjusted linear mixed models showed that younger and older adults had similar weight loss after the LED, whereas older adults had greater sustained weight loss after the WM intervention (adjusted difference for older vs younger adults −1.25% [95% CI −1.92, −0.58], ppp1c and systolic blood pressure after the WM intervention than middle-aged adults. In the complete case analysis, the above-mentioned differences between middle-aged and older adults disappeared, but the direction of the effect size did not change. After the WL period, compared with men, women had less weight loss (adjusted difference for women vs men 1.78% [95% CI 1.12, 2.43], p1c, LDL-cholesterol and diastolic blood pressure. After the WM intervention, women had greater fat-free mass and bone mass loss and smaller improvements in HbA1c and LDL-cholesterol, while they had greater improvements in fasting glucose, triacylglycerol (adjusted difference for women vs men −0.08 mmol/l [−0.11, −0.04], p Conclusions/interpretation Older adults benefited less from a lifestyle intervention in relation to body composition and cardiometabolic health markers than younger adults, despite greater sustained weight loss. Women benefited less from a LED followed by a lifestyle intervention in relation to body weight and body composition than men. Future interventions targeting older adults or women should take prevention of fat-free mass and bone mass loss into consideration. Clinical trial registration number ClinicalTrials.gov NCT01777893. Graphical abstract

Objective To determine the cost-effectiveness of individual face-to-face cognitive behavioral therapy (CBT) compared to therapist guided Internet-based self-help (GSH-I) in overweight or obese adults with binge-eating disorder (BED). Method Analysis was conducted alongside the multicenter randomized controlled INTERBED trial. CBT (n = 76) consisted of up to 20 individual therapy sessions over 4 months. GSH-I (n = 71) consisted of 11 modules combining behavioral interventions, exercises including a self-monitoring food diary, psychoeducation, and 2 face-to-face coaching sessions over 4 months. Assessments at baseline, after 4 months (post-treatment), as well as 6 and 18 months after the end of treatment included health care utilization and sick leave days to calculate direct and indirect costs. Binge-free days (BFD) were calculated as effect measure based on the German version of the Eating Disorder Examination. The incremental cost-effectiveness ratio (ICER) was determined, and net benefit regressions, adjusted for comorbidities and baseline differences, were used to derive cost-effectiveness acceptability curves. Results After controlling for baseline differences, CBT was associated with non-significantly more costs (+€2,539) and BFDs (+40.1) compared with GSH-I during the 22-month observation period, resulting in an adjusted ICER of €63 per additional BFD. CBTs probability of being cost-effective increased above 80% only if societal willingness to pay (WTP) was ≥€250 per BFD. Discussion We did not find clear evidence for one of the treatments being more cost-effective. CBT tends to be more effective but also more costly. If the societal WTP for an additional BFD is low, then our results suggest that GSH-I should rather be adopted.

Objective Internet-based guided self-help (GSH-I) is an efficacious treatment for adults with binge-eating disorder (BED) and overweight or obesity. Although broadly accessible, high dropout from GSH-I has been reported. However, little is known about the factors explaining dropout from GSH-I, including patients' adherence to treatment. Method Within a randomized trial on the treatment of BED, adherence to 4-month GSH-I was objectively assessed in N = 89 patients with BED and overweight or obesity. Objective adherence and subjective treatment evaluation were evaluated as predictors of dropout from GSH-I, defined as having accessed 5 or less of 11 modules. Cutoffs with optimal sensitivity and specificity were derived using Receiver Operating Characteristics curves analysis, and baseline sociodemographic and clinical correlates were determined. Results According to our definition, n = 22 (24.7%) patients were defined as dropouts. Results of the full logistic regression model accounted for 72% of the variance in dropout and all objective adherence parameters (i.e., number of messages exchanged, days with a completed food diary, and days spent per module), but not patients' subjective GSH-I evaluation significantly predicted dropout. Specifically, not completing the food diary in week 7 had maximized sensitivity and specificity in predicting dropout. Patients' body mass index was positively associated with the number of messages exchanged between patients and coaches. No other associations between baseline variables and objective adherence were found. Discussion Patients at risk for dropout from GSH-I can be reliably identified via monitoring of objective adherence and may be provided with additional interventions to prevent dropout.

Importance Although cognitive behavioral therapy (CBT) represents the criterion standard for treatment of binge eating disorder (BED), most individuals do not have access to this specialized treatment. Objective To evaluate the efficacy of internet-based guided self-help (GSH-I) compared with traditional, individual face-to-face CBT. Design, Setting, and Participants The Internet and Binge Eating Disorder (INTERBED) study is a prospective, multicenter, randomized, noninferiority clinical trial (treatment duration, 4 months; follow-ups, 6 months and 1.5 years). A volunteer sample of 178 adult outpatients with full or subsyndromal BED were recruited from 7 university-based outpatient clinics from August 1, 2010, through December 31, 2011; final follow-up assessment was in April 2014. Data analysis was performed from November 30, 2014, to May 27, 2015. Interventions Participants received 20 individual face-to-face CBT sessions of 50 minutes each or sequentially completed 11 internet modules and had weekly email contacts. Main Outcomes and Measures The primary outcome was the difference in the number of days with objective binge eating episodes (OBEs) during the previous 28 days between baseline and end of treatment. Secondary outcomes included OBEs at follow-ups, eating disorder and general psychopathologic findings, body mass index, and quality of life. Results A total of 586 patients were screened, 178 were randomized, and 169 had at least one postbaseline assessment and constituted the modified intention-to-treat analysis group (mean [SD] age, 43.2 [12.3] years; 148 [87.6%] female); the 1.5-year follow-up was available in 116 patients. The confirmatory analysis using the per-protocol sample (n = 153) failed to show noninferiority of GSH-I (adjusted effect, 1.47; 95% CI, −0.01 to 2.91; P = .05). Using the modified intention-to-treat sample, GSH-I was inferior to CBT in reducing OBE days at the end of treatment (adjusted effect, 1.63; 95% CI, 0.17-3.05; P = .03). Exploratory longitudinal analyses also showed the superiority of CBT over GSH-I by the 6-month (adjusted effect, 0.36; 95% CI, 0.23-0.55; P P = .70). Reductions in eating disorder psychopathologic findings were significantly higher in the CBT group than in the GSH-I group at 6-month follow-up (adjusted effect, −0.4; 95% CI, −0.68 to −0.13; P = .005). No group differences were found for body mass index, general psychopathologic findings, and quality of life. Conclusions and Relevance Face-to-face CBT leads to quicker and greater reductions in the number of OBE days, abstinence rates, and eating disorder psychopathologic findings and may be a better initial treatment option than GSH-I. Internet-based guided self-help remains a viable, slower-acting, low-threshold treatment alternative compared with CBT for adults with BED. Trial Registration isrctn.org Identifier:ISRCTN40484777and germanctr.de Identifier:DRKS00000409

Type-2 diabetes (T2D) is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity) for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI) vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand). Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6) years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018.

Background: PlayMancer is a video game designed to increase emotional regulation and reduce general impulsive behaviors, by training to decrease arousal and improve decision-making and planning. We have previously demonstrated the usefulness of PlayMancer in reducing impulsivity and improving emotional regulation in bulimia nervosa (BN) patients. However, whether these improvements are actually translated into brain changes remains unclear. Objective: The aim of this case study was to report on a 28-year-old Spanish woman with BN, and to examine changes in physiological variables and brain activity after a combined treatment of video game therapy (VGT) and cognitive behavioral therapy (CBT). Methods: Ten VGT sessions were carried out on a weekly basis. Anxiety, physiological, and impulsivity measurements were recorded. The patient was scanned in a 1.5-T magnetic resonance scanner, prior to and after the 10-week VGT/CBT combined treatment, using two paradigms: (1) an emotional face-matching task, and (2) a multi-source interference task (MSIT). Results: Upon completing the treatment, a decrease in average heart rate was observed. The functional magnetic resonance imaging (fMRI) results indicated a post-treatment reduction in reaction time along with high accuracy. The patient engaged areas typically active in healthy controls, although the cluster extension of the active areas decreased after the combined treatment. Conclusions: These results suggest a global improvement in emotional regulation and impulsivity control after the VGT therapy in BN, demonstrated by both physiological and neural changes. These promising results suggest that a combined treatment of CBT and VGT might lead to functional cerebral changes that ultimately translate into better cognitive and emotional performances. [J Med Internet Res 2014;16(8):e183]

Although standard psychological treatments have been successful in treating several core features in eating disorders (ED), other characteristics such as emotional regulation or impulsivity appear to be more resistant to change. There is a growing body of evidence to support the efficacy of cognitive remediation for cognitive and emotional difficulties in ED. Playmancer/ Islands is a video game (VG) designed to specifically treat mental disorders, characterized by problems in impulse control. The objective of the game is to increase self-control over emotions, decision making and behaviours. The aim of this study is to describe the results from a consecutive series of nine bulimia nervosa patients who were treated with the VG in addition to cognitive behaviour therapy (CBT). The outcomes included clinical and psychopathological questionnaires, and physiological measures were obtained during the VG. Emotional regulation improved, heart rate variability increased, and respiratory rate and impulsivity measures reduced after the treatment. These findings suggest that VG training may enhance treatment for ED.

Several aspects of social and emotional functioning are abnormal in people with eating disorders. The aim of the present study was to measure facial emotional expression in patients with eating disorders and healthy controls whilst playing a therapeutic video game (Playmancer) designed to train individuals in emotional regulation. Participants were 23 ED patients (11 AN, 12 BN) and 11 HCs. ED patients self reported more anger at baseline but expressed less facial expression of anger during the Playmancer game. The discrepancy between self-report and non-verbal expression may lead to problems in social communication.

Background: Previous review studies have suggested that computer games can serve as an alternative or additional form of treatment in several areas (schizophrenia, asthma or motor rehabilitation). Although several naturalistic studies have been conducted showing the usefulness of serious video games in the treatment of some abnormal behaviours, there is a lack of serious games specially designed for treating mental disorders. Aim: The purpose of our project was to develop and evaluate a serious video game designed to remediate attitudinal, behavioural and emotional processes of patients with impulse-related disorders. Method and results: The video game was created and developed within the European research project PlayMancer. It aims to prove potential capacity to change underlying attitudinal, behavioural and emotional processes of patients with impulse-related disorders. New interaction modes were provided by newly developed components, such as emotion recognition from speech, face and physiological reactions, while specific impulsive reactions were elicited. The video game uses biofeedback for helping patients to learn relaxation skills, acquire better self-control strategies and develop new emotional regulation strategies. In this article, we present a description of the video game used, rationale, user requirements, usability and preliminary data, in several mental disorders.

The object of this study was to examine the effectiveness of an Internet-based therapy (IBT) for bulimia nervosa (BN) as compared to a waiting list (WL). Sixty-two female BN patients, diagnosed according to DSM-IV criteria, were assigned to either the IBT or a WL. The control participants (WL) were matched to the IBT group in terms of age, duration of the disorder, number of previous treatments, and severity of the disorder. Assessment measures included the EDI, SCL-90-R, BITE, the TCI-R, and other clinical and psychopathological indices, which were administrated before and after the treatment. Considering the IBT, while the mean scores were lower at the end of the treatment for some EDI scales (bulimic, interpersonal distrust, maturity fears, and total score) and the BITE symptomatology subscale, the mean BMI was higher at posttherapy. Predictors of good IBT outcome were higher scores on the EDI perfectionism scale and EAT and a higher minimum BMI. Drop-out (after IBT 35.5% of cases) was related to higher SCL-anxiety scores, a lower hyperactivity, a lower minimum BMI, and lower TCI-reward dependence scores. At the end of the treatment, bingeing and vomiting abstinence rates differed significantly between the two groups. Results suggest that an online self-help approach appears to be a valid treatment option for BN when compared to a WL control group, especially for people who present a lower severity of their eating disorder (ED) symptomatology and some specific personality traits.

Cancer patients visiting the emergency center (EC) are seldom assessed or treated for severe fatigue, a common symptom in sick patients due to acute medical conditions arising from cancer and cancer treatment. We provide a profile of cancer-related fatigue within the EC setting. Using a single-item screening tool derived from the Brief Fatigue Inventory, 928 patients (636 with solid tumors, 292 with hematological malignancies) triaged in the EC of a tertiary cancer center rated their fatigue at its worst in the last 24hours. Patient demographic and clinical factors were retrospectively reviewed from medical records. The chief complaints of patients seeking emergency care included fever, pain, gastrointestinal symptoms, dyspnea, fatigue, and bleeding. More than half (54%) reported severe fatigue (seven or higher on a 0–10 scale) upon EC admission. Moderate to severe pain was highly associated with fatigue severity. Patients with severe fatigue were more likely to be unstable and unable to go home after EC care. In multivariate logistic regression analysis for severe fatigue, the significant risk factors for patients with solid tumors included dizziness (odds ratio [OR]=3.59), severe pain (OR=1.98), poor performance status (OR=1.81), and being female (OR=1.56). Dyspnea was significantly associated with severe fatigue in patients with hematological malignancies (OR=4.74). Although fatigue was not the major reason for an ER visit, single-item fatigue-severity screening demonstrated highly prevalent severe fatigue in sicker EC cancer patients and in those patients who also suffered from other symptoms.

Background The objectives were to describe clinical factors associated with hypertension or increased blood pressure in cancer patients seeking acute care, to describe the outcomes of these patients related to hypertension or increased blood pressure, and to determine whether these patients receive appropriate treatment and follow-up instructions. Methods We retrospectively reviewed the records of patients admitted to the emergency center at The University of Texas M. D. Anderson Cancer Center from May 1, 2001 through August 5, 2001. Patients were included in our analysis if their emergency center triage blood pressure was 140 mm Hg or greater, systolic, or 90 mm Hg or greater, diastolic and remained in this range at emergency center discharge or if they were treated with an antihypertensive medication in the emergency center. Descriptive statistics, χ2 and Student t tests were utilized in the analysis. Results Records of 143 patients were analyzed. The mean baseline, emergency center triage, and emergency center discharge blood pressure were 140/78 mm Hg, 159/84 mm Hg, and 153/81 mm Hg, respectively. Of 77 patients (54%) with controlled neoplastic disease, 54 (38%) were not receiving cancer treatment. Forty-one (30%) were admitted to the hospital and 27 (19%) returned to the emergency center with hypertension or possible hypertension-related events within 6 months. Discharge instructions regarding hypertension follow-up were documented in 9% of records. Conclusions Most patients (54%) had controlled cancer; more than one third were not receiving cancer treatment and had good performance status. Such patients would be likely to benefit from management of hypertension. In addition, only 9% of hypertensive patients were given hypertensive specific discharge instructions. The emergency center may provide another opportunity to alert patients of abnormal blood pressures and assist in arranging follow-up.

Summary Objective: This article presents initial results from a European multi-centre study to determine the effectiveness and feasibility of an online self-help treatment support program for Bulimia Nervosa (BN). Method: The online program is based on Cognitive Behavioral Therapy (CBT) and consists of seven steps that patients work through progressively. An overall sample of 141 women suffering from BN used the program over a 6-month period. Patients were supported by three face-to-face evaluation interviews with a therapist, and a weekly e-mail contact. Data on general psychopathology and specific eating disorder symptoms were also collected at the evaluation interviews. Results: Initial results from the Swiss sample (N = 41) showed significant improvement of overall psychological health (p < .001) as measured by the Symptom Checklist (SCL-90R), and for all dimensions of the Eating Disorder Inventory (EDI-2). Conclusion: An online Self-Help program for BN can be used effectively to reduce eating disorder symptoms in Bulimic patients and user feedback showed that this approach contributed to increase patient involvement and service availability. Additional data from the other centers will further inform the efficacy and impact of this approach.

BACKGROUND Hematopoietic stem cell transplantation (HSCT) is an effective but expensive medical procedure to which some ethnic minorities, the elderly, and those without insurance have been shown to have limited access. The purpose of the current study was to determine whether socioeconomic factors were associated with HSCT usage rates in patients with leukemia. METHODS The authors identified 6574 patients with acute lymphocytic leukemia, chronic lymphocytic leukemia, acute myelogenous leukeima, chronic myelogenous leukemia, or other leukemias from the 1999 Texas Hospital Inpatient Discharge Public Use Data File. Of these patients, 1604 received an autologous or allogeneic HSCT. The authors assessed patients' ethnicity, payer status, age, gender, and comorbid medical conditions. Logistic regression was used to control for patient characteristics and to evaluate associations among payer status, ethnicity, and HSCT use. P ≤ 0.05 indicated statistical significance. RESULTS Patients who self-paid had the highest rate of HSCT use in all age groups (32%; P ≤ 0.01) and in the adult group (36%; P = 0.11). Elderly patients with Medicare had a low rate of HSCT use (17%; P = 0.13). Logistic regression showed no statistically significant associations between payer status or ethnicity and HSCT use. However, elderly women were significantly less likely to undergo HSCT than elderly men (odds ratio, 0.34; P ≤ 0.01). CONCLUSIONS The lack of statistically significant differences in HSCT use among adult patients with leukemia was surprising because previous studies had shown differences in HSCT by ethnicity and insurance. Cancer 2004. © 2004 American Cancer Society.

We treated low-risk febrile neutropenic cancer patients utilizing two standard outpatient antibiotic pathways: oral ampicillin/clavulanate (500 mg) and ciprofloxacin (500 mg) or intravenous ceftazidime (2 g) and clindamycin (600 mg) every 8 h. The objectives were to determine the success of outpatient treatment of low-risk febrile neutropenia, to identify factors predicting outpatient failure, and to determine mortality related to the febrile episode.Eligibility criteria included solid tumor diagnosis, stable vital signs, temperatureor =38.0 degrees C, absolute neutrophil count (ANC) of1000/ml, patient compliance, no significant organ dysfunction, ability to tolerate oral medication and fluids for oral pathway, residence within 30 miles of the institution, 24-h caregiver, and telephone and transportation access.There were 257 febrile episodes in 191 patients meeting the criteria. Patients were treated during March 1998 through February 2000. Median age was 48 (range, 17-77) years, and 60% (n = 153) had an entry ANC of100/ml; 205 (80%) febrile episodes successfully responded to outpatient treatment, and 52 (20%) were hospitalized. Logistic regression analysis showed the following were related to hospitalization: mucositisgrade 2 (p0.002); Zubrod performance statusor =2 (p = 0.029); ANC100/ml (p = 0.039), and ageor =70 years (p = 0.048).Outpatient treatment of low-risk febrile neutropenic cancer patients utilizing standard treatment pathways is associated with minimal morbidity and mortality and should be considered an acceptable standard of care with appropriate infrastructure available to provide strict and careful follow-up while on treatment. Certain factors are associated with higher risk of hospitalization and should be further examined in eligible patients with low-risk febrile neutropenia.

PURPOSE: To determine whether antibiotic regimens with similar rates of response differ significantly in the speed of response and to estimate the impact of this difference on the cost of febrile neutropenia. METHODS: The time point of clinical response was defined by comparing the sensitivity, specificity, and predictive values of alternative objective and subjective definitions. Data from 488 episodes of febrile neutropenia, treated with either of two commonly used antibiotics (coded A or B) during six clinical trials, were pooled to compare the median time to clinical response, days of antibiotic therapy and hospitalization, and estimated costs. RESULTS: Response rates were similar; however, the median time to clinical response was significantly shorter with A-based regimens (5 days) compared with B-based regimens (7 days; P = .003). After 72 hours of therapy, 33% of patients who received A but only 18% of those who received B had responded (P = .01). These differences resulted in fewer days of antibiotic therapy and hospitalization with A-based regimens (7 and 9 days) compared with B-based regimens (9 and 12 days, respectively; P < .04) and in significantly lower estimated median costs ($8,491 v $11,133 per episode; P = .03). Early discharge at the time of clinical response should reduce the median cost from $10,752 to $8,162 (P < .001). CONCLUSION: Despite virtually identical rates of response, time to clinical response and estimated cost of care varied significantly among regimens. An early discharge strategy based on our definition of the time point of clinical response may further reduce the cost of treating non–low-risk patients with febrile neutropenia.