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People on low-fat, low-energy-density diets have lower ad libitum energy intake than that of those on high-fat, high-energy-density diets.

ObjectiveTo determine the accuracy of wrist and arm-worn activity monitors’ estimates of energy expenditure (EE).Data sourcesSportDISCUS (EBSCOHost), PubMed, MEDLINE (Ovid), PsycINFO (EBSCOHost), Embase (Ovid) and CINAHL (EBSCOHost).DesignA random effects meta-analysis was performed to evaluate the difference in EE estimates between activity monitors and criterion measurements. Moderator analyses were conducted to determine the benefit of additional sensors and to compare the accuracy of devices used for research purposes with commercially available devices.Eligibility criteriaWe included studies validating EE estimates from wrist-worn or arm-worn activity monitors against criterion measures (indirect calorimetry, room calorimeters and doubly labelled water) in healthy adult populations.Results60 studies (104 effect sizes) were included in the meta-analysis. Devices showed variable accuracy depending on activity type. Large and significant heterogeneity was observed for many devices (I2 >75%). Combining heart rate or heat sensing technology with accelerometry decreased the error in most activity types. Research-grade devices were statistically more accurate for comparisons of total EE but less accurate than commercial devices during ambulatory activity and sedentary tasks.ConclusionsEE estimates from wrist and arm-worn devices differ in accuracy depending on activity type. Addition of physiological sensors improves estimates of EE, and research-grade devices are superior for total EE. These data highlight the need to improve estimates of EE from wearable devices, and one way this can be achieved is with the addition of heart rate to accelerometry.PROSPEROregistration numberCRD42018085016.

Since the prostate-specific membrane antigen (PSMA) is frequently over-expressed in prostate cancer (PCa) several PSMA-targeting molecules are under development to detect and treat metastatic castration resistant prostate cancer (mCRPC). We investigated the tissue kinetics of a small molecule inhibitor of PSMA ((S)-2-(3-((S)-1-carboxy-5-(3-(4-[(124)I]iodophenyl)ureido)pentyl)ureido)pentanedioicacid; MIP-1095) using PET/CT to estimate radiation dosimetry for the potential therapeutic use of (131)I-MIP-1095 in men with mCRPC. We also report preliminary safety and efficacy of the first 28 consecutive patients treated under a compassionate-use protocol with a single cycle of (131)I-MIP-1095. Sixteen patients with known prostate cancer underwent PET/CT imaging after i.v. administration of (124)I-MIP-1095 (mean activity: 67.4 MBq). Each patient was scanned using PET/CT up to five times at 1, 4, 24, 48 and 72 h post injection. Volumes of interest were defined for tumor lesions and normal organs at each time point followed by dose calculations using the OLINDA/EXM software. Twenty-eight men with mCRPC were treated with a single cycle of (131)I-MIP-1095 (mean activity: 4.8 GBq, range 2 to 7.2 GBq) and followed for safety and efficacy. Baseline and follow up examinations included a complete blood count, liver and kidney function tests, and measurement of serum PSA. I-124-MIP-1095 PET/CT images showed excellent tumor uptake and moderate uptake in liver, proximal intestine and within a few hours post-injection also in the kidneys. High uptake values were observed only in salivary and lacrimal glands. Dosimetry estimates for I-131-MIP-1095 revealed that the highest absorbed doses were delivered to the salivary glands (3.8 mSv/MBq, liver (1.7 mSv/MBq) and kidneys (1.4 mSv/MBq). The absorbed dose calculated for the red marrow was 0.37 mSv/MBq. PSA values decreased by >50 % in 60.7 % of the men treated. Of men with bone pain, 84.6 % showed complete or moderate reduction in pain. Hematological toxicities were mild. Of men treated, 25 % had a transient slight to moderate dry mouth. No adverse effects on renal function were observed. Based on the biodistribution and dose calculations of the PSMA-targeted small molecule (124)I-MIP-1095 therapy with the authentic analog (131)I-MIP-1095 enables a targeted tumor therapy with unprecedented doses delivered to the tumor lesions. Involved lymph node and bone metastases were exposed to estimated absorbed doses upwards of 300 Gy.

Introduction Since the prostate-specific membrane antigen (PSMA) is frequently over-expressed in prostate cancer (PCa) several PSMA-targeting molecules are under development to detect and treat metastatic castration resistant prostate cancer (mCRPC). We investigated the tissue kinetics of a small molecule inhibitor of PSMA (( S )-2-(3-(( S )-1-carboxy-5-(3-(4-[ 124 I]iodophenyl)ureido)pentyl)ureido)pentanedioicacid; MIP-1095) using PET/CT to estimate radiation dosimetry for the potential therapeutic use of 131 I-MIP-1095 in men with mCRPC. We also report preliminary safety and efficacy of the first 28 consecutive patients treated under a compassionate-use protocol with a single cycle of 131 I-MIP-1095. Methods Sixteen patients with known prostate cancer underwent PET/CT imaging after i.v. administration of 124 I-MIP-1095 (mean activity: 67.4 MBq). Each patient was scanned using PET/CT up to five times at 1, 4, 24, 48 and 72 h post injection. Volumes of interest were defined for tumor lesions and normal organs at each time point followed by dose calculations using the OLINDA/EXM software. Twenty-eight men with mCRPC were treated with a single cycle of 131 I-MIP-1095 (mean activity: 4.8 GBq, range 2 to 7.2 GBq) and followed for safety and efficacy. Baseline and follow up examinations included a complete blood count, liver and kidney function tests, and measurement of serum PSA. Results I-124-MIP-1095 PET/CT images showed excellent tumor uptake and moderate uptake in liver, proximal intestine and within a few hours post-injection also in the kidneys. High uptake values were observed only in salivary and lacrimal glands. Dosimetry estimates for I-131-MIP-1095 revealed that the highest absorbed doses were delivered to the salivary glands (3.8 mSv/MBq, liver (1.7 mSv/MBq) and kidneys (1.4 mSv/MBq). The absorbed dose calculated for the red marrow was 0.37 mSv/MBq. PSA values decreased by >50 % in 60.7 % of the men treated. Of men with bone pain, 84.6 % showed complete or moderate reduction in pain. Hematological toxicities were mild. Of men treated, 25 % had a transient slight to moderate dry mouth. No adverse effects on renal function were observed. Conclusion Based on the biodistribution and dose calculations of the PSMA-targeted small molecule 124 I-MIP-1095 therapy with the authentic analog 131 I-MIP-1095 enables a targeted tumor therapy with unprecedented doses delivered to the tumor lesions. Involved lymph node and bone metastases were exposed to estimated absorbed doses upwards of 300 Gy.

BackgroundThere is evidence that the energetic demand of metabolically active tissue is associated with day-to-day food intake (EI). However, the extent to which behavioural components of total daily energy expenditure (EE) such as activity energy expenditure (AEE) are also associated with EI is unknown. Therefore, the present study examined the cross-sectional associations between body composition, resting metabolic rate (RMR), AEE and EI.MethodsData for 242 individuals (114 males; 128 females; BMI = 25.7 ± 4.9 kg/m2) were collated from the baseline control conditions of five studies employing common measures of body composition (air displacement plethysmography) and RMR (indirect calorimetry). Daily EI (weighed-dietary records) and EE (FLEX heart rate) were measured over 6–7 days, and AEE was calculated as total daily EE minus RMR.ResultsLinear regression indicated that RMR (β = 0.39; P < 0.001), fat mass (β = −0.26; P < 0.001) and AEE (β = 0.18; P = 0.002) were independent predictors of mean daily EI, with AEE adding ≈3% of variance to the model after controlling for age, sex and study (F(10, 231) = 18.532, P < 0.001; R2 = 0.445). Path analyses indicated that the effect of FFM on mean daily EI was mediated by RMR (P < 0.05), while direct (β = 0.19; P < 0.001) and indirect (β = 0.20; P = 0.001) associations between AEE and mean daily EI were observed.ConclusionsWhen physical activity was allowed to vary under free-living conditions, AEE was associated with mean daily EI independently of other biological determinants of EI arising from body composition and RMR. These data suggest that EE per se exerts influence over daily food intake, with both metabolic (RMR) and behavioral (AEE) components of total daily EE potentially influencing EI via their contribution to daily energy requirements.

Recent research has suggested that obesity is a stigmatised condition. Concerns with personal inferiority (social rank), shame and self-criticism may impact on weight management behaviours. The current study examined associations between social comparison (shame, self-criticism), negative affect and eating behaviours in women attending a community based weight management programme focused on behaviour change. 2,236 participants of the programme completed an online survey using measures of shame, self-criticism, social comparison, and weight-related affect, which were adapted to specifically address eating behaviour, weight and body shape perceptions. Correlation analyses showed that shame, self-criticism and social comparison were associated with negative affect. All of these variables were related to eating regulation and weight control (p < 0.001). Path analysis revealed that the association of shame, hated-self, and low self-reassurance on disinhibition and susceptibility to hunger was fully mediated by weight-related negative affect, even when controlling for the effect of depressive symptoms (p < 0.050 to p < 0.010). In addition, feelings of inadequacy and unfavourable social comparisons were associated with higher disinhibition and susceptibility to hunger, partially mediated through weight-related negative affect (p = 0.001). These variables were negatively associated with extent of weight loss during programme attendance prior to the survey, while self-reassurance and positive social comparisons were positively associated with the extent of weight loss prior to the survey (p < .050). Shame, self-criticism, and perceptions of inferiority may play a significant role in self-regulation of eating behaviour in overweight people trying to manage their weight.

Several studies have suggested that reduced sleep duration and quality are associated with an increased risk of obesity and related metabolic disorders, but the role of sleep in long-term weight loss maintenance (WLM) has not been thoroughly explored using prospective data. The present study is an ancillary study based on data collected on participants from the Navigating to a Healthy Weight (NoHoW) trial, for which the aim was to test the efficacy of an evidence-based digital toolkit, targeting self-regulation, motivation, and emotion regulation, on WLM among 1,627 British, Danish, and Portuguese adults. Before enrolment, participants had achieved a weight loss of [greater than or equal to]5% and had a BMI of [greater than or equal to]25 kg/m.sup.2 prior to losing weight. Participants were enrolled between March 2017 and March 2018 and followed during the subsequent 12-month period for change in weight (primary trial outcome), body composition, metabolic markers, diet, physical activity, sleep, and psychological mediators/moderators of WLM (secondary trial outcomes). For the present study, a total of 967 NoHoW participants were included, of which 69.6% were women, the mean age was 45.8 years (SD 11.5), the mean baseline BMI was 29.5 kg/m.sup.2 (SD 5.1), and the mean weight loss prior to baseline assessments was 11.4 kg (SD 6.4). Objectively measured sleep was collected using the Fitbit Charge 2 (FC2), from which sleep duration, sleep duration variability, sleep onset, and sleep onset variability were assessed across 14 days close to baseline examinations. The primary outcomes were 12-month changes in body weight (BW) and body fat percentage (BF%). The secondary outcomes were 12-month changes in obesity-related metabolic markers (blood pressure, low- and high-density lipoproteins [LDL and HDL], triglycerides [TGs], and glycated haemoglobin [HbA1c]). Analysis of covariance and multivariate linear regressions were conducted with sleep-related variables as explanatory and subsequent changes in BW, BF%, and metabolic markers as response variables. We found no evidence that sleep duration, sleep duration variability, or sleep onset were associated with 12-month weight regain or change in BF%. A higher between-day variability in sleep onset, assessed using the standard deviation across all nights recorded, was associated with weight regain (0.55 kg per hour [95% CI 0.10 to 0.99]; P = 0.016) and an increase in BF% (0.41% per hour [95% CI 0.04 to 0.78]; P = 0.031). Analyses of the secondary outcomes showed that a higher between-day variability in sleep duration was associated with an increase in HbA1c (0.02% per hour [95% CI 0.00 to 0.05]; P = 0.045). Participants with a sleep onset between 19:00 and 22:00 had the greatest reduction in diastolic blood pressure (DBP) (P = 0.02) but also the most pronounced increase in TGs (P = 0.03). The main limitation of this study is the observational design. Hence, the observed associations do not necessarily reflect causal effects. Our results suggest that maintaining a consistent sleep onset is associated with improved WLM and body composition. Sleep onset and variability in sleep duration may be associated with subsequent change in different obesity-related metabolic markers, but due to multiple-testing, the secondary exploratory outcomes should be interpreted cautiously.

Technological advances in remote monitoring offer new opportunities to quantify body weight patterns in free-living populations. This paper describes body weight fluctuation patterns in response to weekly, holiday (Christmas) and seasonal time periods in a large group of individuals engaged in a weight loss maintenance intervention. Data was collected as part The NoHoW Project which was a pan-European weight loss maintenance trial. Three eligible groups were defined for weekly, holiday and seasonal analyses, resulting in inclusion of 1,421, 1,062 and 1,242 participants, respectively. Relative weight patterns were modelled on a time series following removal of trends and grouped by gender, country, BMI and age. Within-week fluctuations of 0.35% were observed, characterised by weekend weight gain and weekday reduction which differed between all groups. Over the Christmas period, weight increased by a mean 1.35% and was not fully compensated for in following months, with some differences between countries observed. Seasonal patterns were primarily characterised by the effect of Christmas weight gain and generally not different between groups. This evidence may improve current understanding of regular body weight fluctuation patterns and help target future weight management interventions towards periods, and in groups, where weight gain is anticipated.

Accurate solutions for the estimation of physical activity and energy expenditure at scale are needed for a range of medical and health research fields. Machine learning techniques show promise in research-grade accelerometers, and some evidence indicates that these techniques can be applied to more scalable commercial devices. This study aims to test the validity and out-of-sample generalizability of algorithms for the prediction of energy expenditure in several wearables (ie, Fitbit Charge 2, ActiGraph GT3-x, SenseWear Armband Mini, and Polar H7) using two laboratory data sets comprising different activities. Two laboratory studies (study 1: n=59, age 44.4 years, weight 75.7 kg; study 2: n=30, age=31.9 years, weight=70.6 kg), in which adult participants performed a sequential lab-based activity protocol consisting of resting, household, ambulatory, and nonambulatory tasks, were combined in this study. In both studies, accelerometer and physiological data were collected from the wearables alongside energy expenditure using indirect calorimetry. Three regression algorithms were used to predict metabolic equivalents (METs; ie, random forest, gradient boosting, and neural networks), and five classification algorithms (ie, k-nearest neighbor, support vector machine, random forest, gradient boosting, and neural networks) were used for physical activity intensity classification as sedentary, light, or moderate to vigorous. Algorithms were evaluated using leave-one-subject-out cross-validations and out-of-sample validations. The root mean square error (RMSE) was lowest for gradient boosting applied to SenseWear and Polar H7 data (0.91 METs), and in the classification task, gradient boost applied to SenseWear and Polar H7 was the most accurate (85.5%). Fitbit models achieved an RMSE of 1.36 METs and 78.2% accuracy for classification. Errors tended to increase in out-of-sample validations with the SenseWear neural network achieving RMSE values of 1.22 METs in the regression tasks and the SenseWear gradient boost and random forest achieving an accuracy of 80% in classification tasks. Algorithms trained on combined data sets demonstrated high predictive accuracy, with a tendency for superior performance of random forests and gradient boosting for most but not all wearable devices. Predictions were poorer in the between-study validations, which creates uncertainty regarding the generalizability of the tested algorithms.

Background Hemorrhage is the most common cause of potentially preventable death after injury. Balanced transfusion with red blood cells, plasma, and platelets (component therapy, CT) has been shown to reduce mortality, and is the standard of care. Low-Titer Group O Whole Blood (LTOWB) is an attractive alternative to CT, but existing evidence comprises observational studies, and a small single center pilot randomized controlled trial, which evaluated a type of whole blood that is no longer in use. The aim of the “Trauma Resuscitation with Low-Titer Group O Whole Blood Or Products” (TROOP) trial is to compare the effectiveness and safety of LTOWB and CT in critically injured patients predicted to require a large volume transfusion. Methods This is a pragmatic, multicenter, Bayesian, sequential non-inferiority/superiority, randomized clinical trial, performed within 15 level I trauma centers in the United States. We aim to randomize 1,100 injured patients to resuscitation with either CT or LTOWB. The primary outcome is 6-h mortality. Secondary outcomes include 24-h and 30-day or hospital mortality (whichever is earlier); prespecified complications; adjudicated cause of death; time to death; length of stay (ICU and hospital); and hospital-, ventilator- and ICU-free days; the incidence of major surgical procedures; time to hemostasis in those undergoing procedures with a hemostatic component; number and type of blood products used until hemostasis is achieved (and randomized products are discontinued), as well as after hemostasis has been achieved, to 24 h post-admission; discharge destination and functional status and quality of life at hospital discharge or 30 days, as measured by Glasgow Coma Scale (GCS) and EuroQol (EQ-5D) quality of life measurement. Discussion This large multicenter clinical trial will contribute high-level evidence on the effectiveness of Low-Titer Group O Whole Blood in the in-hospital management of trauma patients predicted to require a large volume transfusion. Trial registration National Clinical Trial Identified Number: NCT05638581. Clinical trial registry: https://clinicaltrials.gov/study/NCT05638581 First submitted 2022–11-08.