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Graphene active sensors have emerged as a promising building block for large-scale neural interfaces. The authors evaluate their performance in terms of wide frequency band sensitivity, stability and biocompatibility and perform proof-of-concept long-term wireless recording in a freely behaving rodent.

Abstract Functional neuroimaging has contributed substantially to understanding brain function but is dominated by group analyses that index only a fraction of the variation in these data. It is increasingly clear that parsing the underlying heterogeneity is crucial to understand individual differences and the impact of different task manipulations. We estimate large-scale (N = 7728) normative models of task-evoked activation during the Emotional Face Matching Task, which enables us to bind heterogeneous datasets to a common reference and dissect heterogeneity underlying group-level analyses. We apply this model to a heterogenous patient cohort, to map individual differences between patients with one or more mental health diagnoses relative to the reference cohort and determine multivariate associations with transdiagnostic symptom domains. For the face>shapes contrast, patients have a higher frequency of extreme deviations which are spatially heterogeneous. In contrast, normative models for faces>baseline have greater predictive value for individuals’ transdiagnostic functioning. Taken together, we demonstrate that normative modelling of fMRI task-activation can be used to illustrate the influence of different task choices and map replicable individual differences, and we encourage its application to other neuroimaging tasks in future studies.

Space travel has transformed in the past several years. Given the burgeoning market for space tourism, in-flight medical emergencies are likely to be expected. Ultrasound is one of the few diagnostic and therapeutic modalities available for astronauts in space. However, while point-of-care ultrasound (POCUS) is available, there is no current standard of training for astronaut preparation. We suggest an organized and structured methodology by which astronauts should best prepare for space with the medical equipment available on board. As technology continues to evolve, the assistance of other artificial intelligence and augmented reality systems are likely to facilitate training and dynamic real-time needs during space emergencies. Summary: As space tourism continues to evolve, an organized methodology for POCUS use is advised to best prepare astronauts for space.

Abstract Background Obesity disproportionally impacts rural, lower-income children in the United States. Primary care providers are well-positioned to engage parents in early obesity prevention, yet there is a lack of evidence regarding the most effective care delivery models. The ENCIRCLE study, a pragmatic cluster-randomized controlled trial, will respond to this gap by testing the comparative effectiveness of standard care well-child visits (WCV) versus two enhancements: adding a patient-reported outcome (PRO) measure (PRO WCV) and PRO WCV plus Food Care (telehealth coaching and a grocery store tour). Methods A total of 2,025 parents and their preschool-aged children (20–60 months of age) will be recruited from 24 Geisinger primary care clinics, where providers are randomized to the standard WCV, PRO WCV, or PRO WCV plus Food Care intervention arms. The PRO WCV includes the standard WCV plus collection of the PRO—the Family Nutrition and Physical Activity (FNPA) risk assessment—from parents. Parents complete the PRO in the patient-portal or in the clinic (own device, tablet, or kiosk), receive real-time feedback, and select priority topics to discuss with the provider. These results are integrated into the child’s electronic health record to inform personalized preventive counseling by providers. PRO WCV plus Food Care includes referrals to community health professionals who deliver evidence-based obesity prevention and food resource management interventions via telehealth following the WCV. The primary study outcome is change in child body mass index z-score (BMIz), based on the World Health Organization growth standards, 12 months post-baseline WCV. Additional outcomes include percent of children with overweight and obesity, raw BMI, BMI50, BMIz extended, parent involvement in counseling, health behaviors, food resource management, and implementation process measures. Discussion Study findings will inform health care systems’ choices about effective care delivery models to prevent childhood obesity among a high-risk population. Additionally, dissemination will be informed by an evaluation of mediating, moderating, and implementation factors. Trial registration ClinicalTrials.gov identifier (NCT04406441); Registered May 28, 2020.

Abstract Background/Objective Parents shape children’s early experiences with food, influencing what is served, children’s food choices, and how much children eat. Responsive parenting (RP) interventions such as INSIGHT have improved maternal infant feeding practices, but have only been tested among predominantly White families. This secondary analysis of data from the Sleep SAAF (Strong African American Families) RCT tests the effects of an RP intervention designed to prevent rapid infant weight gain on African American mothers’ infant feeding practices. Methods Primiparous African American mother-infant dyads (n = 194) were randomized to an RP or safety control intervention delivered by community research associates at infant age 3 and 8 weeks. At 16 weeks, mothers completed the Babies Need Feeding questionnaire, the Infant Feeding Styles Questionnaire, and the Babies Need Soothing questionnaire. Logistic regression and general linear models examined the effect of study group on infant feeding practices. Moderation analyses explored whether effects varied by feeding mode (any breast milk versus exclusive formula), maternal age (≥ 20 years versus

Abstract Background Firstborn children have higher rates of obesity compared to secondborns, perhaps due, in part, to differential feeding practices. Despite the centrality of siblings in family life and potential for influence, almost nothing is known about the role of siblings in parent feeding practices in early childhood. Methods Participants (n = 117) were mothers of consecutively born siblings. Firstborns participated in an RCT that compared a responsive parenting intervention designed for primary prevention of obesity against a safety control. Secondborns participated in an observational cohort. Multilevel models tested whether and how firstborn characteristics (temperament, appetite, rapid weight gain) at 16 weeks and 1 year were associated maternal feeding practices of secondborns in infancy at 16 weeks, 28 weeks, and 1 year (food to soothe) and at ages 1, 2, and 3 years (structure-and control-based feeding practices). A purposive subsample (n = 30) of mothers also participated in semi-structured interviews to further illuminate potential sibling influences on maternal feeding practices during infancy and toddlerhood. Results Firstborn characteristics did not predict secondborn feeding in infancy (all ps > 0.05). Firstborn negative affect, however, predicted mothers’ less consistent mealtime routines (b (SE) = − 0.27 (0.09); p = 0.005) and more pressure (b (SE) = 0.38 (0.12); p = 0.001). Firstborn appetite predicted mothers’ less frequent use of food to soothe (b (SE) = − 0.16 (0.07); p = 0.02) when secondborns were toddlers. Firstborn surgency, regulation, and rapid weight gain, however, did not predict secondborn feeding practices during toddlerhood (all ps > 0.05). Interviews with mothers revealed three ways that maternal experiences with firstborns informed feeding practices of secondborns: 1) Use of feeding practices with secondborn that worked for the firstborn; 2) Confidence came from firstborn feeding experiences making secondborn feeding less anxiety-provoking; and 3) Additional experiences with firstborn and other factors that contributed to secondborn feeding practices. Conclusions Some firstborn characteristics and maternal experiences with firstborns as well as maternal psychosocial factors may have implications for mothers’ feeding practices with secondborns. Together, these mixed methods findings may inform future research and family-based interventions focused on maternal feeding of siblings in early childhood.

Abstract Trial Design Excessive gestational weight gain (GWG) can increase pregnancy morbidity and is particularly problematic for women with pregestational obesity. A lifestyle modification intervention was introduced to gravida with obesity to decrease excessive GWG as compared to usual care (UC). Methods A randomized controlled trial was conducted to improve healthy lifestyle behaviors to manage appropriate GWG. Consenting participants with prepregnancy obesity and singletons ≤17 weeks were randomized to (1) Usual Care (UC): usual written educational materials and counseling by obstetric provider or (2) Enhanced Care (EC): UC plus (a) personalized letter from physician detailing appropriate GWG; (b) access to individualized GWG chart; (c) ongoing counseling with registered dietitian/nutritionist (RDN). The primary outcome was proportion with GWG ≤9.1 kg, as this is upper limit recommended by Institute of Medicine (IOM). Total GWG and GWG as less than/within/greater than IOM recommendations (in aggregate and stratified by obesity class), and pregnancy/neonatal outcomes were evaluated as secondary outcomes. Results Analyses included 105 participants in EC and 109 in UC arms. The groups had similar demographics: 46% with class I obesity, 26% class II, and 28% class III. There were no group differences for any GWG, pregnancy, or neonatal outcomes when analyzed in aggregate. As compared to those randomized to the EC arm, participants in UC arm with class I obesity gained 1.4 kg less and those with class II obesity were significantly more likely to gain within IOM guidelines (14.8% vs. 40.0%, adjusted p = 0.04). Participants with class III obesity randomized to EC arm were more likely to gain within IOM guidelines as compared to participants randomized to UC arm (29.0% vs. 6.7%, adjusted p = 0.02). Conclusion There were no differences in GWG observed between groups when analyzing participants in aggregate. However, a physician's letter detailing appropriate GWG, patient portal access to a personalized GWG chart, and RDN consultation were helpful for encouraging GWG within IOM guidelines for women with prepregnancy class III obesity. Women with class I or II obesity had better GWG outcomes without these additional interventions.

The authors argue that embracing life necessitates a shift in how we conceptualize wellness in education. They delve into the exploration of humanizing wellness and living well by drawing on Black onto-epistemologies, specifically referencing Bambara’s The Salt Eaters. This exploration involves examining how notions of wholeness manifest in the text and the subsequent implications for educators and scholars actively involved in anti-equity efforts. The authors elucidate both the possibilities and challenges related to care, touch, and celebration. In particular, they employ the concept of Black refusal to investigate how these elements can propel a critical departure from conventional ideas of wellness in the United States, paving the way for alternative modes of existence which prioritize wholeness. To achieve this, the authors present an exploration of the literature on whiteness, epistemology, and the destructive impact of anti-Blackness. The authors then introduce Black refusal as a theoretical framework, which functions as the frame guiding their methods. Examining personal reflective instances of engagement with the present political landscape, analyzing Bambara’s The Salt Eaters, and maintaining refusal as a central theoretical framework, the authors detail an epistemology of wholeness centered on care, touch, and celebration.

Abstract Clinical trial managers play a vital role in the design and conduct of clinical trials in the UK. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to the COVID-19 pandemic. Academic clinical trial units and departments are struggling to recruit trial managers to vacant positions, and multiple influences are affecting the retention of this highly skilled workforce. Without tackling this issue, we face major challenges in the delivery on the Department of Health and Social Care’s Future of UK Clinical Research Delivery implementation plan. This article, led by a leading network of and for UK Trial Managers, presents some of the issues and ways in which national stakeholders may be able to address this.

Background/objectivesAlthough cortisol levels increase during normal pregnancy, particularly high levels of cortisol or stress have been associated with adverse maternal/child outcomes. Obesity is associated with altered cortisol metabolism, but there is limited information on pregnancy-related changes in cortisol in pregnant women with overweight/obesity. The objective of this study was to examine weekly measures of urinary cortisol and perceived stress throughout ~10-36 weeks gestation, if levels differ by pre-pregnancy BMI categories, and whether concurrent measures of urinary cortisol and perceived stress are associated.MethodsLongitudinal observational data from Healthy Mom Zone, a gestational weight management intervention, and an ancillary fetal growth study were combined. Pregnant women with normal (n=7), overweight (n=11), or obese (n=14) pre-pregnancy BMI were recruited at >8 weeks gestation. Overnight urinary cortisol and Perceived Stress Scale were measured weekly from ~10-36 weeks gestation.ResultsHigher pre-pregnancy BMI was associated with overall lower urinary cortisol throughout gestation, but rate of increase in urinary cortisol across pregnancy was similar across weight status groups. Women with obesity reported higher levels of overall perceived stress than normal weight women. Regardless of weight status, perceived stress was not associated with gestational age or cortisol.ConclusionsAlthough women with obesity reported higher perceived stress, they had lower urinary cortisol than women with normal BMI, and gestation-related increases in cortisol were similar across weight groups and unrelated to perceived stress, suggesting that physiological factors that drive increases in cortisol as pregnancy may outweigh effects of stress and adiposity.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03945266, identifier (NCT03945266)

Patient reported outcome measures (PROM) can engage patients and clinicians to improve health outcomes. Their population health impact may be limited by systematic barriers inhibiting access to completion. In this analysis we evaluated the association between individual parent/child characteristics and clinic factors with parental completion of a locally developed PROM, the Early Healthy Lifestyles (EHL) questionnaire. Participants included parent-child dyads who presented at 14 pediatric clinics for regularly scheduled well-child visits (WCV) prior to age 26 months. EHL items include feeding practices, diet, play time, screen exposure, and sleep. Completion was categorized at patient- (i.e., parent-child dyad) and clinic-levels. Parents completed the 15-item EHL in the patient portal before arrival or in the clinic; ninety-three percent of EHL questionnaires were completed in the clinic vs. 7% in the patient portal. High-completers completed EHL for half of WCVs; low-completers completed at least once; and non-completers never completed. Clinics were classified by EHL adoption level (% high completion): High-adoption: >50%; Moderate-adoption: 10%–50%; and Low-adoption: 1 clinic site for WCV (OR = 1.83 [1.34, 2.50]), non-White birth mother (OR = 1.78 [1.28, 2.47]), and body weight

Natasha Savage develops a general finite difference method for modeling 2D diffusion using a 1D reduced model. This method can be useful to improve the accuracy of many reduced-dimension models while retaining benefits of system simplification.

Summary Background Excess intake of desserts/sweets high in added sugars, such as candy, is linked with greater obesity risk. Parents often limit their childrens' intake of these sweet foods using controlling feeding practices, such as restriction; yet, restrictive feeding practices are counterproductive for childrens' self‐regulation of energy intake. Objective This study developed a family‐based behavioural intervention that taught parents alternatives to restrictive feeding practices and encouraged children to consume candy in moderation. Methods Using the multiphase optimization strategy (MOST), parent–child dyads (N = 37) were randomized into one of eight conditions that included a combination of intervention components delivered over 4 weeks: home supply, parent shared decision making, child mindfulness and child attention control strategies. Results Retention rate at follow‐up was high (95%). Among parents who received parent shared decision making, 86.4% reported the structured‐based candy routine they set with their child was easy to follow. Most children reported child mindfulness (95%) and attention control (89.5%) strategies were easy to play. Children recalled 4.1 ± 1.8 of the six mindfulness strategies and 2.7 ± 1.6 of the five attention control strategies at follow‐up. Eating in the absence of hunger tended to be lower for children who received parent shared decision making and child mindfulness components. Conclusion This intervention was feasible and well‐implemented in the home environment. Findings will inform future, larger interventions designed to test similar strategies on childrens; eating behaviours and self‐regulation.

Pregnant women are at a high risk for experiencing sleep disturbances, excess energy intake, low physical activity, and excessive gestational weight gain (GWG). Scant research has examined how sleep behaviors influence energy intake, physical activity, and GWG over the course of pregnancy. This study conducted secondary analyses from the Healthy Mom Zone Study to examine between- and within-person effects of weekly sleep behaviors on energy intake, physical activity, and GWG in pregnant women with overweight/obesity (PW-OW/OB) participating in an adaptive intervention to manage GWG. The overall sample of N = 24 (M age = 30.6 years, SD = 3.2) had an average nighttime sleep duration of 7.2 h/night. In the total sample, there was a significant between-person effect of nighttime awakenings on physical activity; women with >1 weekly nighttime awakening expended 167.56 less physical activity kcals than women with

The ‘core’ regions of the default mode network (DMN) – the medial prefrontal cortex (MPFC), the posterior cingulate cortex (PCC), and inferior parietal lobules (IPL) – show consistent engagement across mental states that involve self-oriented processing. Precisely how these regions interact in support of such processes remains an important unanswered question. In the current functional magnetic resonance imaging (fMRI) study, we examined dynamic interactions of the ‘core-self’ DMN regions during two forms of self-referential cognition: direct self-appraisal (thinking about oneself) and reflected self-appraisal (thinking about oneself from a third-person perspective). One-hundred and eleven participants completed our dual self-appraisal task during fMRI, and general linear models were used to characterize common and distinct neural responses to these conditions. Informed by these results, we then applied dynamic causal modelling to examine causal interactions among the ‘core-self’ regions, and how they were specifically modulated under the influence of direct and reflected self-appraisal. As a primary observation, this network modelling revealed a distinct inhibitory influence of the left IPL on the PCC during reflected compared to direct self-appraisal, which was accompanied by evidence of greater activation in both regions during the reflected self-appraisal condition. We suggest that the greater engagement of posterior DMN regions during reflected self-appraisal is a function of the higher-order processing needed for this form of self-appraisal, with the left IPL supporting abstract self-related processes including episodic memory retrieval and shifts of perspective. Overall, we show that core DMN regions interact in functionally unique ways in support of self-referential processes, even when these processes are inter-related. Further characterization of DMN functional interactions across self-related mental states is likely to inform a deeper understanding of how this brain network orchestrates the self.

Threat learning elicits robust changes across multiple affective domains, including changes in autonomic indices and subjective reports of fear and anxiety. It has been argued that the underlying causes of such changes may be dissociable at a neural level, but there is currently limited evidence to support this notion. To address this, we examined the neural mediators of trial-by-trial skin conductance responses (SCR), and subjective reports of anxious arousal and valence in participants (n = 27; 17 females) performing a threat reversal task during ultra-high field functional magnetic resonance imaging. This allowed us to identify brain mediators during initial threat learning and subsequent threat reversal. Significant neural mediators of anxious arousal during threat learning included the dorsal anterior cingulate, anterior insula cortex (AIC), and ventromedial prefrontal cortex (vmPFC), subcortical regions including the amygdala, ventral striatum, caudate and putamen, and brain-stem regions including the pons and midbrain. By comparison, autonomic changes (SCR) were mediated by a subset of regions embedded within this broader circuitry that included the caudate, putamen and thalamus, and two distinct clusters within the vmPFC. The neural mediators of subjective negative valence showed prominent effects in posterior cortical regions and, with the exception of the AIC, did not overlap with threat learning task effects. During threat reversal, positive mediators of both subjective anxious arousal and valence mapped to the default mode network; this included the vmPFC, posterior cingulate, temporoparietal junction, and angular gyrus. Decreased SCR during threat reversal was positively mediated by regions including the mid cingulate, AIC, two sub-regions of vmPFC, the thalamus, and the hippocampus. Our findings add novel evidence to support distinct underlying neural processes facilitating autonomic and subjective responding during threat learning and threat reversal. The results suggest that the brain systems engaged in threat learning mostly capture the subjective (anxious arousal) nature of the learning process, and that appropriate responding during threat reversal is facilitated by participants engaging self- and valence-based processes. Autonomic changes (SCR) appear to involve distinct facilitatory and regulatory contributions of vmPFC sub-regions.

Candy provides little nutritional value and contributes to children’s energy intake from added sugars. Factors influencing children’s candy intake remain largely unknown. This study describes children’s total candy intake (kcal) before and after a meal and examines associations of candy intake in both conditions with children’s temperament and appetite among a predominantly White, highly educated sample. Children (n = 38, age 5–8 years) were given free access to 11 candies (5 chocolate, 6 non-chocolate) and non-food alternatives during a pre-meal and a post-meal condition. Parents completed the Child Behavior Questionnaire and the Child Eating Behavior Questionnaire. Total candy intake was less when offered after a meal (209.3 kcal; SD = 111.25) than before a meal when still hungry (283.6 kcal; SD = 167.3), but not statistically different. Individual differences in candy intake between conditions was calculated to categorize children into three groups: “Better Regulators” consumed more candy before a meal (39%), “Consistent/Poorer Regulators” consumed similar amounts before and after a meal regardless of hunger (32%), and “Most Disinhibited” children consumed more candy after a meal when not hungry (29%). The “Better Regulators” group was lowest in negative affect and the “Consistent/Poorer Regulators” group was highest in food responsiveness. Children’s candy intake was high relative to daily energy needs both before and after a meal. Child negative affect and food responsiveness appear to be child characteristics that predispose children to poor self-regulation of candy intake before and after a meal.

Introduction Severe SARS-CoV-2 infection is associated with a dysregulated immune response. Inflammatory monocytes and macrophages are crucial, promoting injurious, proinflammatory sequelae. Immunomodulation is, therefore, an attractive therapeutic strategy and we sought to test licensed and novel candidate drugs.Methods and analysis The CATALYST trial is a multiarm, open-label, multicentre, phase II platform trial designed to identify candidate novel treatments to improve outcomes of patients hospitalised with COVID-19 compared with usual care. Treatments with evidence of biomarker improvements will be put forward for larger-scale testing by current national phase III platform trials. Hospitalised patients >16 years with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription PCR assay) and a C reactive protein (CRP) ≥40 mg/L are eligible. The primary outcome measure is CRP, measured serially from admission to day 14, hospital discharge or death. Secondary outcomes include the WHO Clinical Progression Improvement Scale as a principal efficacy assessment.Ethics and dissemination The protocol was approved by the East Midlands-Nottingham 2 Research Ethics Committee (20/EM/0115) and given urgent public health status; initial approval was received on 5 May 2020, current protocol version (V.6.0) approval on 12 October 2020. The MHRA also approved all protocol versions. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.Trial registration numbers EudraCT2020-001684-89, ISRCTN40580903.

Summary Objective Integration of behavioural risk assessment into well‐child visits is recommended by clinical guidelines, but its feasibility and impact is unknown. Methods A quasi‐experimental study evaluated the feasibility and effectiveness of risk assessment on body mass index (BMI) at 1‐year follow‐up. Children with assessments (intervention) were compared with those who did not complete assessments (non‐respondent) and those who received standard care (non‐exposed). Results Analyses included 10,647 children aged 2–9 years (2,724 intervention, 3,324 non‐respondent and 4,599 non‐exposed). Forty‐five per cent of parents completed the assessments. Intervention and non‐respondent groups differed in change in BMI z‐score at 1 year by −0.05 (confidence interval [CI]: −0.08, −0.02; P = 0.0013); no difference was observed with non‐exposed children. The intervention group had a smaller increase in BMI z‐score (0.07 ± 0.63) than non‐respondent group (0.13 ± 0.63). For children with normal weight at baseline, intervention versus non‐respondent groups differed in BMI z‐score change by −0.06 (CI: −0.10, −0.02; P = 0.0025). However, children with overweight at baseline in the intervention versus the non‐exposed group differed in BMI z‐score change (0.07 [CI: 0.02, 0.14]; P = 0.016). When analysed by age, results were similar for 2‐ to 5‐year‐olds, but no differences were found for 6‐ to 9‐year‐olds. Conclusion Automating risk assessment in paediatric care is feasible and effective in promoting healthy weight among preschool but not older children.

Abstract Background Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months. Methods/design Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the “RP intervention” or “standard care control” groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child’s electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes. Discussion This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs. Trial registration Restrospective Clinical Trial Registration: NCT03482908. Registered March 29, 2018.

MOTIVATION:The measurement of disease biomarkers in easily-obtained bodily fluids has opened the door to a new type of non-invasive medical diagnostics. New technologies are being developed and fine-tuned in order to make this possibility a reality. One such technology is Field Asymmetric Ion Mobility Spectrometry (FAIMS), which allows the measurement of volatile organic compounds (VOCs) in biological samples such as urine. These VOCs are known to contain a range of information on the relevant person's metabolism and can in principle be used for disease diagnostic purposes. Key to the effective use of such data are well-developed data processing pipelines, which are necessary to extract the most useful data from the complex underlying biological structure. RESULTS:In this study, we present a new data analysis pipeline for FAIMS data, and demonstrate a number of improvements over previously used methods. We evaluate the effect of a series of candidate operational steps during data processing, such as the use of wavelet transforms, principal component analysis (PCA), and classifier ensembles. We also demonstrate the use of FAIMS data in our pipeline to diagnose diabetes on the basis of a simple urine sample using machine learning classifiers. We present results for data generated from a case-control study of 115 urine samples, collected from 72 type II diabetic patients, with 43 healthy volunteers as negative controls. The resulting pipeline combines the steps that resulted in the best classification model performance. These include the use of a two-dimensional discrete wavelet transform, and the Wilcoxon rank-sum test for feature selection. We are able to achieve a best ROC curve AUC of 0.825 (0.747-0.9, 95% CI) for classification of diabetes vs control. We also note that this result is robust to changes in the data pipeline and different analysis runs, with AUC > 0.80 achieved in a range of cases. This is a substantial improvement in performance over previously used data processing methods in this area. Our ability to make strong statements about FAIMS ability to diagnose diabetes is sadly limited, as we found confounding effects from the demographics when including these data in the pipeline. The demographics alone produced a best AUC of 0.87 (0.795-0.94, 95% CI). While the combination of the demographics and FAIMS data resulted in an improvement on the AUC (0.907; 0.848-0.97, 95% CI), it did not prove to be a significant difference. Nevertheless, the pipeline itself shows a significant improvement in performance over more basic methods which have been used with FAIMS data in the past.

High gestational weight gain (GWG) in overweight/obese pregnant women increases maternal-fetal complications. We conducted a 6-week GWG intervention based on an energy balance model that includes theories of planned behavior (TPB) and self-regulation constructs to promote exercise and healthy eating motivation and behaviors. The purposes of this proof-of-concept feasibility study were to examine: (1) the energy balance model constructs over the intervention, and (2) pre-post intervention, weekly, and dose-response changes in study constructs. Methods. Overweight/obese pregnant women (N=17) were randomized to 1 of 6 conditions, increasing in intensity, and included varied combinations of components (exercise sessions, healthy eating demonstrations, etc.). Exercise and healthy eating TPB (attitude, subjective norm, perceived behavioral control, intention), and self-regulation (prospective, retrospective) constructs were collected weekly. Exercise behavior, energy intake, and GWG were collected daily. Results. We observed: (a) significant increases in exercise TPB constructs, healthy eating attitude (limit unhealthy foods), exercise/healthy eating retrospective self-regulation; (b) significant decrease in healthy eating subjective norm (limit unhealthy foods); (c) trending increases for healthy eating perceived behavioral control (limit unhealthy foods), healthy eating prospective self-regulation, and energy intake; (d) significantly higher active time, steps, and energy expenditure at W3 relative to other weeks; (e) no significant increase in GWG; and, (f) a dose response effect such that women in more intensive dosages had greater gains in exercise and healthy eating perceived behavioral control (eat healthy/limit unhealthy foods). Conclusion. Brief exposure to a theoretically-driven, GWG intervention resulted in changes to exercise and healthy eating TPB and self-regulation motivational determinants, no significant increase in GWG, and suggests intervention intensity can strengthen perceived ability to engage in exercise/healthy eating behaviors; offering initial proof-of-concept for the intervention to regulate GWG in overweight/obese pregnant women. Future research will test this intervention over the course of pregnancy to understand long-term impact on maternal-fetal health outcomes.