A Comparison of Personality, Life Events, Comorbidity, and Health in Monozygotic Twins Discordant for Anorexia Nervosa.

Genetic and environmental factors contribute to the etiology of anorexia nervosa (AN). The co-twin control design is one of the most powerful methods available to evaluate environmental factors that could contribute to differences between monozygotic (MZ) twins who are discordant for AN. Using available data from a unique and rare sample of 22 Swedish female MZ pairs discordant for AN, we compared personality, life events, comorbidity, and health factors. Twins with AN had significantly higher perfectionism scores than unaffected co-twins and reported younger ages at first diet than unaffected co-twins who had dieted. Consistent with previous literature, more twins with AN reported gastrointestinal problems than unaffected co-twins. Although not significant due to low statistical power, more unaffected co-twins reported experiencing emotional neglect than twins with AN. Early dieting may be a harbinger of the development of AN or an early symptom. Higher perfectionism may represent a risk factor, sequela, or both. Sibling perception of neglect is noteworthy given the impact of an ill child with AN on family function and wellbeing. The health and wellbeing of siblings should be addressed clinically when one child in the family suffers from AN.

Binge-Eating Disorder in Adults: A Systematic Review and Meta-analysis.

BACKGROUND: The best treatment options for binge-eating disorder are unclear. PURPOSE: To summarize evidence about the benefits and harms of psychological and pharmacologic therapies for adults with binge-eating disorder. DATA SOURCES: English-language publications in EMBASE, the Cochrane Library, Academic OneFile, CINAHL, and ClinicalTrials.gov through 18 November 2015, and in MEDLINE through 12 May 2016. STUDY SELECTION: 9 waitlist-controlled psychological trials and 25 placebo-controlled trials that evaluated pharmacologic (n = 19) or combination (n = 6) treatment. All were randomized trials with low or medium risk of bias. DATA EXTRACTION: 2 reviewers independently extracted trial data, assessed risk of bias, and graded strength of evidence. DATA SYNTHESIS: Therapist-led cognitive behavioral therapy, lisdexamfetamine, and second-generation antidepressants (SGAs) decreased binge-eating frequency and increased binge-eating abstinence (relative risk, 4.95 [95% CI, 3.06 to 8.00], 2.61 [CI, 2.04 to 3.33], and 1.67 [CI, 1.24 to 2.26], respectively). Lisdexamfetamine (mean difference [MD], -6.50 [CI, -8.82 to -4.18]) and SGAs (MD, -3.84 [CI, -6.55 to -1.13]) reduced binge-eating-related obsessions and compulsions, and SGAs reduced symptoms of depression (MD, -1.97 [CI, -3.67 to -0.28]). Headache, gastrointestinal upset, sleep disturbance, and sympathetic nervous system arousal occurred more frequently with lisdexamfetamine than placebo (relative risk range, 1.63 to 4.28). Other forms of cognitive behavioral therapy and topiramate also increased abstinence and reduced binge-eating frequency and related psychopathology. Topiramate reduced weight and increased sympathetic nervous system arousal, and lisdexamfetamine reduced weight and appetite. LIMITATIONS: Most study participants were overweight or obese white women aged 20 to 40 years. Many treatments were examined only in single studies. Outcomes were measured inconsistently across trials and rarely assessed beyond end of treatment. CONCLUSION: Cognitive behavioral therapy, lisdexamfetamine, SGAs, and topiramate reduced binge eating and related psychopathology, and lisdexamfetamine and topiramate reduced weight in adults with binge-eating disorder. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Reproductive and Appetite Hormones and Bulimic Symptoms during Midlife.

Eating disorders and related symptoms occur during midlife; however, little is known about their aetiology. It has been hypothesised that perimenopause represents a window of vulnerability for the development or exacerbation of eating disorder symptomatology because, like puberty, perimenopause is a period of reproductive hormone change. We compared symptoms of bulimia nervosa (bulimic symptomatology) assessed via mean scores on a self-report questionnaire in premenopausal and perimenopausal women. We also examined the association between hormone concentrations (reproductive/appetite) and bulimic symptomatology. No mean differences in bulimic symptomatology were observed between premenopause and perimenopause. However, there was a significant positive association between leptin and binge eating. Although no significant associations between reproductive hormones and bulimic symptomatology were observed, additional research is needed to provide definitive information. It is essential to learn more about the aetiology of eating disorders and related symptomatology across the lifespan in order to develop age-relevant treatment and prevention programs. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

Comparative Effectiveness of Treatments for Binge-Eating Disorder: Systematic Review and Network Meta-Analysis.

Psychological and pharmacological interventions for binge-eating disorder have previously demonstrated efficacy (compared with placebo or waitlist control); thus, we aimed to expand that literature with a review of comparative effectiveness. We searched MEDLINE,® EMBASE,® Cochrane Library, Academic OneFile, CINAHL® for binge-eating disorder treatment articles and selected studies using predetermined inclusion and exclusion criteria. Data were sufficient for network meta-analysis comparing two pharmacological interventions; psychological interventions were analysed qualitatively. In all, 28 treatment comparisons were included in this review: one pharmacological comparison (second-generation antidepressants versus lisdexamfetamine) and 26 psychological comparisons. Only three statistically significant differences emerged: lisdexamfetamine was better at increasing binge abstinence than second-generation antidepressants; therapist-led cognitive behavioural therapy was better at reducing binge-eating frequency than behavioural weight loss, but behavioural weight loss was better at reducing weight. The majority of other treatment comparisons revealed few significant differences between groups. Thus, patients and clinicians can choose from several effective treatment options. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

Body image, aging, and identity in women over 50: The Gender and Body Image (GABI) study.

We conducted a qualitative study of 1,849 women over age 50 to capture the thoughts, feelings, and attitudes that women at middle age have about their bodies and the experience of aging. Via an open-ended question online survey, four primary themes emerged: (a) the physical and psychological experience of aging; (b) the injustices, inequities, and challenges of aging; (c) the importance of self-care; and (d) a plea for recognition of the need to maintain a contributory role in society. Results highlight the complexities of women's psychological and physical aspects of aging and point toward important topics worthy of further study in this growing population.

Active ghrelin and the postpartum.

Postpartum depression (PPD) occurs in 10-15 % of women. The appetite hormone ghrelin, which fluctuates during pregnancy, is associated with depression in nonpregnant samples. Here, we examine the association between PPD and active ghrelin from pregnancy to postpartum. We additionally examine whether ghrelin changes from pregnancy to postpartum and differs between breastfeeding and non-breastfeeding women. Sixty women who participated in a survey examining PPD and had information in regard to ghrelin concentrations were included in the study. The Edinburgh Postnatal Depression Scale was used to assess symptoms of PPD. Raw ghrelin levels and ghrelin levels adjusted for creatinine were included as outcomes. Women screening positive for PPD at 12 weeks postpartum had higher pregnancy ghrelin concentrations. Ghrelin concentrations significantly decreased from pregnancy to 6 weeks postpartum and this change differed based on pregnancy depression status. Finally, ghrelin levels were lower in women who breastfed compared with women who were bottle-feeding. No significant findings remained once ghrelin levels were adjusted for creatinine. Although results do not suggest an association between PPD and ghrelin after adjusting for creatinine, future research should continue to explore this possibility extending further across the postpartum period with larger sample sizes.

Peripheral Biomarkers of Anorexia Nervosa: A Meta-Analysis.

The pathogenesis of anorexia nervosa (AN) has been hypothesized to involve several biological systems. However, reliable biomarkers for AN have yet to be established. This study was aimed to identify statistically significant and clinically meaningful peripheral biomarkers associated with AN. A systematic literature search was conducted to identify studies published in English from inception until 30 June 2022. We conducted two-level random-effects meta-analyses to examine the difference between AN and comparison groups across 52 distinct biomarkers and found that acylated ghrelin, adrenocorticotropic hormone (ACTH), carboxy-terminal collagen crosslinks (CTX), cholesterol, cortisol, des-acyl ghrelin, ghrelin, growth hormone (GH), obestatin, and soluble leptin receptor levels were significantly higher in cases of AN compared with those in non-AN controls. Conversely, C-reactive protein (CRP), CD3 positive, CD8, creatinine, estradiol, follicle-stimulating hormone (FSH), free thyroxine, free triiodothyronine, glucose, insulin, insulin-like growth factor 1 (IGF-1), leptin, luteinizing hormone, lymphocyte, and prolactin levels were significantly lower in AN compared with those in non-AN controls. Our findings indicate that peripheral biomarkers may be linked to the pathophysiology of AN, such as processes of adaptation to starvation. Scientific investigation into peripheral biomarkers may ultimately yield breakthroughs in personalized clinical care for AN.

Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the U.S. Preventive Services Task Force.

BACKGROUND: Alcohol misuse, which includes the full spectrum from risky drinking to alcohol dependence, is a leading cause of preventable death in the United States. PURPOSE: To evaluate the benefits and harms of behavioral counseling interventions for adolescents and adults who misuse alcohol. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Library, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and reference lists of published literature (January 1985 through January 2012, limited to English-language articles). STUDY SELECTION: Controlled trials at least 6 months' duration that enrolled persons with alcohol misuse identified by screening in primary care settings and evaluated behavioral counseling interventions. DATA EXTRACTION: One reviewer extracted data and a second checked accuracy. Two independent reviewers assigned quality ratings and graded the strength of the evidence. DATA SYNTHESIS: The 23 included trials generally excluded persons with alcohol dependence. The best evidence was for brief (10- to 15-minute) multicontact interventions. Among adults receiving behavioral interventions, consumption decreased by 3.6 drinks per week from baseline (weighted mean difference, 3.6 drinks/wk [95% CI, 2.4 to 4.8 drinks/wk]; 10 trials; 4332 participants), 12% fewer adults reported heavy drinking episodes (risk difference, 0.12 [CI, 0.07 to 0.16]; 7 trials; 2737 participants), and 11% more adults reported drinking less than the recommended limits (risk difference, 0.11 [CI, 0.08 to 0.13]; 9 trials; 5973 participants) over 12 months compared with control participants (moderate strength of evidence). Evidence was insufficient to draw conclusions about accidents, injuries, or alcohol-related liver problems. Trials enrolling young adults or college students showed reduced consumption and fewer heavy drinking episodes (moderate strength of evidence). Little or no evidence of harms was found. LIMITATIONS: Results may be biased to the null because the behavior of control participants could have been affected by alcohol misuse assessments. In addition, evidence is probably inapplicable to persons with alcohol dependence and selective reporting may have occurred. CONCLUSION: Behavioral counseling interventions improve behavioral outcomes for adults with risky drinking. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Body dissatisfaction in women across the lifespan: results of the UNC-SELF and Gender and Body Image (GABI) studies.

To explore age differences in current and preferred silhouette and body dissatisfaction (current - preferred silhouette discrepancy) in women aged 25-89 years using figural stimuli [range: 1 (very small) to 9 (very large)]. Data were abstracted from two online convenience samples (N = 5868). t-tests with permutation-adjusted p-values examined linear associations between mean silhouette scores (current, preferred, discrepancy score) and age with/without stratification by body mass index (BMI). Modal current silhouette was 5; modal preferred silhouette was 4; mean discrepancy score was 1.8. There was no significant association between current silhouette and age, but a positive linear association between preferred silhouette and age remained after stratification by BMI. A significant inverse linear association of silhouette discrepancy score and age was found only prior to stratification by BMI. Body dissatisfaction exists in women across the adult life span and is influenced by BMI.

Characteristics of women with body size satisfaction at midlife: results of the Gender and Body Image (GABI) Study.

This study characterizes the profile of women (N = 1,789) ages 50 and over who report body size satisfaction on a figure rating scale. Satisfied women (12.2%) had a lower body mass index and reported fewer eating disorder symptoms, dieting behaviors, and weight and appearance dissatisfaction. Interestingly, satisfied women exercised more than dissatisfied women, and weight and shape still played a primary role in their self-evaluation. Weight monitoring and appearance-altering behaviors did not differ between groups. Body satisfaction was associated with better overall functioning. This end point appears to represent effortful body satisfaction rather than passive contentment.

Low-glycemic load decreases postprandial insulin and glucose and increases postprandial ghrelin in white but not black women.

Alterations in appetite hormones favoring increased postprandial satiety have been implicated in both the glycemic control and potential weight-loss benefits of a low-glycemic diet. Racial differences exist in dietary glycemic load and appetite hormone concentrations. This study examined the impact of glycemic load on appetite hormones in 20 black women [10 normal weight, BMI = 22.8 ± 1.42 (mean ± SD); 10 obese, BMI = 35.1 ± 2.77] and 20 white women (10 normal weight, BMI = 22.9 ± 1.45; 10 obese, BMI = 34.3 ± 2.77). Each woman completed two 4.5-d weight-maintenance, mixed-macronutrient, high-glycemic vs. low-glycemic load diets that concluded with a test meal of identical composition. Blood samples collected before and serially for 3 h after each test meal were assayed for plasma ghrelin and serum insulin and glucose concentrations. Compared with the high-glycemic load meal, the low-glycemic load meal was associated with lower insulin(AUC) (P = 0.02), glucose(AUC) (P = 0.01), and urge to eat ratings (P = 0.05) but with higher ghrelin(AUC) (P = 0.008). These results suggest the satiating effect of a low-glycemic load meal is not directly linked to enhanced postprandial suppression of ghrelin. Notably, these effects were significant among white but not black women, suggesting that black women may be less sensitive than white women to the glucoregulatory effects of a low-glycemic load. These findings add to a growing literature demonstrating racial differences in postprandial appetite hormone responses. If reproducible, these findings have implications for individualized diet prescription for the purposes of glucose or weight control in women.

Eating disorder symptoms and weight and shape concerns in a large web-based convenience sample of women ages 50 and above: results of the Gender and Body Image (GABI) study.

OBJECTIVE: Limited research exists on eating disorder symptoms and attitudes and weight and shape concerns in women in midlife to older adulthood. We conducted an online survey to characterize these behaviors and concerns in women ages 50 and above. METHOD: Participants (n = 1,849) were recruited via the Internet and convenience sampling. RESULTS: Eating disorder symptoms, dieting and body checking behaviors, and weight and shape concerns were widely endorsed. Younger age and higher body mass index (BMI) were associated with greater endorsement of eating disorder symptoms, behaviors, and concerns. DISCUSSION: Weight and shape concerns and disordered eating behaviors occur in women over 50 and vary by age and BMI. Focused research on disordered eating patterns in this age group is necessary to develop age-appropriate interventions and to meet the developmental needs of an important, growing, and underserved population.

Associations of Stress and Appetite Hormones with Binge Eating in Females with Anorexia Nervosa after Weight Restoration: A Longitudinal Study.

Binge eating is a transdiagnostic eating disorder symptom that can occur in patients with anorexia nervosa (AN), persisting after weight restoration, and impeding their recovery. However, little is known about the biological predictors of binge eating after AN weight restoration. The goals of this exploratory study of 73 females with AN were: (1) to examine changes in cortisol, the adrenocorticotropic hormone, norepinephrine, ghrelin (total and active), and leptin levels across the admission, discharge, and 3 months post-discharge from the inpatient AN weight restoration; and (2) to determine whether the target hormones were associated with objective or subjective binge eating (OBE or SBE). The participants completed the self-reported Eating Disorder Examination Questionnaire, Beck Anxiety Inventory, and Beck Depression Inventory-II, and provided fasting whole blood samples for hormone assays. The results showed significant changes in body mass index (BMI), cortisol, total ghrelin, and leptin levels over the three time points. The cortisol levels at admission and discharge were significantly associated with the number of SBE episodes at 3 months post-discharge. Findings suggest the need to replicate and confirm the role of cortisol in predicting the emergence of SBE and uncover the mechanisms underlying SBE and cortisol to prevent SBE and its negative consequences.

Informed consent: Old and new challenges in the context of the COVID-19 pandemic.

In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19. Then, we discuss how informed consent processes were modified or changed to address the pandemic, consider what lessons were learned, and present research and policy steps to prepare for future research and public health crises. The experiences and challenges for CTSA institutions offer an important perspective for examining what we have learned about informed consent and determining the next steps for improving the consent process.

ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices): The evolution of a collaborative regional CTSA-funded forum and website for regulatory support.

Availability of trained professionals to assist researchers navigating regulatory pathways for new drug and device development is limited within academic institutions. We created ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices), a regional forum initially involving regulatory professionals from four Clinical and Translational Science Award (CTSA)-funded institutions, to build and capitalize on local expertise and to develop a regulatory guidance website geared toward academic researchers. Since 2015, members organized 15 forums covering topics such as FDA premarket submissions, gene therapy, and intellectual property for devices and therapeutics. Through user feedback, targeted surveys, and ongoing iterative processes, we refined and maintained a shared regulatory website, which reached 6000+ users in 2019. Website updates improved navigation to drug versus device topic areas, provided new educational content and videos to address commonly asked questions, and created a portal for posting upcoming training opportunities. Survey respondents rated the website favorably and endorsed expanding ReGARDD as a centralized resource. ReGARDD strengthened the regional regulatory workforce, increased regulatory efficiency, and promulgated best organizational and operational practices. Broad-scale deployment of the ReGARDD model across the CTSA consortium may facilitate the creation of a network of regional forums and reduce gaps in access to regulatory support.

Malodor as a trigger of stress and negative mood in neighbors of industrial hog operations.

OBJECTIVES: We evaluated malodor and air pollutants near industrial hog operations as environmental stressors and negative mood triggers. METHODS: We collected data from 101 nonsmoking adults in 16 neighborhoods within 1.5 miles of at least 1 industrial hog operation in eastern North Carolina. Participants rated malodor intensity, stress, and mood for 2 weeks while air pollutants were monitored. RESULTS: Reported malodor was associated with stress and 4 mood states; odds ratios (ORs) for a 1-unit change on the 0-to-8 odor scale ranged from 1.31 (95% confidence interval [CI] = 1.16, 1.50) to 1.81 (95% CI = 1.63, 2.00). ORs for stress and feeling nervous or anxious were 1.18 (95% CI = 1.08, 1.30) and 1.12 (95% CI = 1.03, 1.22), respectively, for a 1 ppb change in hydrogen sulfide and 1.06 (95% CI = 1.00, 1.11) and 1.10 (95% CI = 1.03, 1.17), respectively, for a 1 microg/m(3) change in semivolatile particulate matter less than 10 microm in aerodynamic diameter (PM(10)). CONCLUSIONS: Hog odor, hydrogen sulfide, and semivolatile PM(10) are related to stress and negative mood in disproportionately low-income communities near industrial hog operations in eastern North Carolina. Malodor should be considered in studies of health impacts of environmental injustice.

The biology of binge eating.

OBJECTIVE: To examine the literature on binge eating to gain a better understanding of its biological foundations and their role in eating disorders. METHOD: Literature review and synthesis. RESULTS: Research using animal models has revealed several factors that contribute to the development and maintenance of binge eating. These factors, including stress, food restriction, the presence of palatable foods, and environmental conditioning, parallel many of the precursory circumstances leading to binge eating in individuals with bulimia nervosa and binge eating disorder. DISCUSSION: The animal literature has opened a new avenue to aid in the understanding of the neurobiological basis of binge eating. Future endeavors examining the genetic and environmental correlates of binge eating behavior will further contribute to the understanding of the biological foundations of binge eating and assist with establishing diagnostic criteria and the development of novel treatments for eating disorders marked by binge eating.

Broad-scale informed consent: A survey of the CTSA landscape.

INTRODUCTION: Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common Rule's strict regulatory definition for "broad consent") may facilitate the use of existing data and samples and speed the pace of research by minimizing barriers to consent. We explored the use of broad-scale informed consent within the Clinical Translational Science Award (CTSA) Program Network. METHODS: We surveyed CTSA Hubs concerning policies, practices, experiences, and needs within three domains of broad-scale informed consent: (1) participant recontact; (2) biospecimens; and (3) clinical data sharing. RESULTS: Of 61 CTSA Hubs surveyed, 37 (61%) indicated ongoing work related to at least 1 domain of broad-scale informed consent; 18 Hubs (30%) reported work in all 3 domains. The EHR predominated as the implementation system across all three domains. Research and IT leadership and the Institutional Review Board were most commonly endorsed as institutional drivers, while systems/technical issues and impact on clinical workflow were the most commonly reported barriers. CONCLUSIONS: While survey results indicate considerable variability in the implementation of broad-scale informed consent across the CTSA consortium, it is clear that all CTSA Hubs are actively considering policy and process related to these concepts. Next steps cluster within three areas: training and workforce development, streamlined policies and templates, and implementation strategies that facilitate integration into clinical workflow.

Early treatment-related changes in diabetes and cardiovascular disease risk markers in first episode psychosis subjects.

OBJECTIVE: To examine prospective changes in cardiovascular disease (CVD) and type-2 diabetes risk factors in young adult first episode psychotic (FEP) patients treated with second generation antipsychotic medications. METHODS: At baseline, fasting serum and anthropometric measures were obtained from 45 FEP patients and 41 healthy adults (controls) of similar age, ethnicity and sex; sixteen of the FEP patients remained on the same antipsychotic medication and were available for a second blood draw at 24 weeks of treatment. Serum was assayed for glucose, insulin, triglycerides, total cholesterol and high and low density lipoproteins (HDL, LDL), adiponectin, leptin, interleukin 6, E-selectin and VCAM-1. Wilcoxon nonparametric tests were used to compare risk markers between the FEP and control group at baseline and to evaluate pre-post treatment changes within the FEP group. RESULTS: At baseline, the distributions of risk marker values were similar between the two groups and the percentages of FEP patients and healthy controls who were overweight/obese, dyslipidemic, hyperglycemic, and hyperinsulinemic did not differ. At 24 weeks, compared to baseline, FEP patients showed significant increases in BMI (p=0.0002), glucose (p=0.0449), insulin (p=0.0161), cholesterol (p=0.0129), leptin (p=0.0215), and E-selectin (p=0.0195), and a decrease in adiponectin (p=0.0371). CONCLUSIONS: Among patients with first episode psychosis, 6-month treatment with second generation antipsychotics is associated with the exacerbation of pre-existing and emergence of new CVD and diabetes risk factors.