A Pilot Multisensory Approach for Emotional Eating: Pivoting from Virtual Reality to a 2-D Telemedicine Intervention during the COVID-19 Pandemic.

BACKGROUND AND OBJECTIVES: Emotional eating (EE), or eating in response to negative emotions or stress, can be understood as a manifestation of difficulties regulating emotions among individuals with eating disorders. To date, many virtual reality treatments for eating disorders have focused on body image or exposure methods and have not exclusively targeted EE. There has been a call made by experts in the field for a "new generation" of virtual reality interventions, capable of utilizing virtual reality's potential more fully. We developed a novel emotion regulation (ER) intervention based upon virtual reality to improve EE among adults with an eating disorder diagnosis. The study hypothesized that a novel ER protocol utilizing evidence-based strategies, as well as innovative techniques, would be feasible and acceptable and show preliminary signals of effectiveness for EE. MATERIALS AND METHODS: Due to COVID-19, the study pivoted from the original completely immersive intervention to a 2-D intervention deliverable over telehealth. Twenty-one patients were recruited from the Adult Eating Disorders Program within Stanford University to receive seven weekly one-hour virtual experiences (VEs) focusing on ER. Participants were not randomized but, as part of a pragmatic study design, chose between the novel VE-Emotion Regulation (VE-ER) intervention or continuing their treatment as usual. Before and after the seven sessions, participants completed an assessment by filling out online questionnaires. RESULTS: Overall, VE-ER treatment was feasible, and the participant and therapist acceptability of VE-ER treatment was fairly high. In terms of preliminary effectiveness, the results showed a significant reduction in the frequencies of disordered eating behaviors in both groups, but a greater improvement in EE in the VE-ER group and a significant reduction in emotion dysregulation after the treatment. CONCLUSIONS: This novel pilot study makes a valuable contribution to the scant literature by demonstrating the feasibility, acceptability, and preliminary effectiveness of combining somatic, multisensory, and cognitive manipulations delivered via telemedicine to help patients with EE to manage their emotions. The findings can serve as the basis for larger, controlled studies evaluating the translation of the somatic marker theory from the research literature into real-world U.S. clinic settings.

Pilot study of responsive nucleus accumbens deep brain stimulation for loss-of-control eating.

Cravings that precede loss of control (LOC) over food consumption present an opportunity for intervention in patients with the binge eating disorder (BED). In this pilot study, we used responsive deep brain stimulation (DBS) to record nucleus accumbens (NAc) electrophysiology during food cravings preceding LOC eating in two patients with BED and severe obesity (trial registration no. NCT03868670). Increased NAc low-frequency oscillations, prominent during food cravings, were used to guide DBS delivery. Over 6 months, we observed improved self-control of food intake and weight loss. These findings provide early support for restoring inhibitory control with electrophysiologically-guided NAc DBS. Further work with increased sample sizes is required to determine the scalability of this approach.

Aberrant impulse control circuitry in obesity.

The ventromedial prefrontal cortex (vmPFC) to nucleus accumbens (NAc) circuit has been implicated in impulsive reward-seeking. This disinhibition has been implicated in obesity and often manifests as binge eating, which is associated with worse treatment outcomes and comorbidities. It remains unclear whether the vmPFC-NAc circuit is perturbed in impulsive eaters with obesity. Initially, we analyzed publicly available, high-resolution, normative imaging data to localize where vmPFC structural connections converged within the NAc. These structural connections were found to converge ventromedially in the presumed NAc shell subregion. We then analyzed multimodal clinical and imaging data to test the a priori hypothesis that the vmPFC-NAc shell circuit is linked to obesity in a sample of female participants that regularly engaged in impulsive eating (i.e., binge eating). Functionally, vmPFC-NAc shell resting-state connectivity was inversely related to body mass index (BMI) and decreased in the obese state. Structurally, vmPFC-NAc shell structural connectivity and vmPFC thickness were inversely correlated with BMI; obese binge-prone participants exhibited decreased vmPFC-NAc structural connectivity and vmPFC thickness. Finally, to examine a causal link to binge eating, we directly probed this circuit in one binge-prone obese female using NAc deep brain stimulation in a first-in-human trial. Direct stimulation of the NAc shell subregion guided by local behaviorally relevant electrophysiology was associated with a decrease in number of weekly episodes of uncontrolled eating and decreased BMI. This study unraveled vmPFC-NAc shell circuit aberrations in obesity that can be modulated to restore control over eating behavior in obesity.

Can responsive deep brain stimulation be a cost-effective treatment for severe obesity?

OBJECTIVE: A first-in-human responsive deep brain stimulation (rDBS) trial (NCT03868670) for obesity is under way, which is based on promising preclinical evidence. Given the upfront costs of rDBS, it is prudent to examine the success threshold for cost-effectiveness compared with laparoscopic Roux-en-Y gastric bypass (LRYGB). METHODS: Efficacy and safety data on LRYGB and safety data on rDBS were collected for established indications through a literature search. The success threshold was defined as minimum BMI reduction. Treatment costs were calculated via Medicare national reimbursement data. RESULTS: LRYGB had a mean BMI reduction of 13.75 kg/m2 . Based on adverse events, LRYGB was a less-preferred health state (overall adverse event utility of 0.96 [0.02]) than rDBS (0.98 [0.01]), but LRYGB ($14,366 [$6,410]) had a significantly lower treatment cost than rDBS ($29,951 [$4,490]; p < 0.0001). Therefore, for rDBS to be cost-effective compared with LRYGB, the multiple models yielded a success threshold range of 13.7 to 15.2 kg/m2 . CONCLUSIONS: This study established a preliminary efficacy success threshold for rDBS to be cost-effective for severe obesity, and results from randomized controlled trials are needed. This analysis allows for interpretation of the economic impact of advancing rDBS for obesity in light of ongoing trial results and suggests an attainable threshold is needed for cost-effectiveness.

Opioid use among patients with pain syndromes commonly seeking surgical consultation: A retrospective cohort.

BACKGROUND: Surgeons often see patients with pain to exclude organic pathology and consider surgical treatment. We examined factors associated with long-term opioid therapy among patients with foot/ankle, anorectal, and temporomandibular joint pain to aid clinical decision making. METHODS: Using the IBM MarketScan® Research Database, we conducted a retrospective cohort analysis of patients aged 18-64 with a clinical encounter for foot/ankle, anorectal, or temporomandibular joint pain (January 2007-September 2015). Multivariable logistic regression was used to estimate adjusted odds ratios for factors associated with long-term opioid therapy, including age, sex, geographic region, pain condition, psychiatric diagnoses, and surgical procedures in the previous year. RESULTS: The majority of the cohort of 1,500,392 patients were women (61%). Within the year prior to the first clinical encounter for a pain diagnosis, 14% had an encounter for a psychiatric diagnosis, and 11% had undergone a surgical procedure. Long-term opioid therapy was received by 2.7%. After multivariable adjustment, older age (age 50-64 vs. 18-29: aOR 4.47, 95% CI 4.24-4.72, p < 0.001), region (South vs. Northeast, aOR 1.76, 95% CI 1.70-1.81, p < 0.001), recent surgical procedure (aOR 1.83, 95% CI 1.78-1.87, p < 0.001), male sex (aOR 1.14, 95% CI 1.12-1.16, p < 0.001) and recent psychiatric diagnosis (aOR 2.49, 95% CI 2.43-2.54, p < 0.001) were independently associated with long-term opioid therapy. CONCLUSION: Among patients with foot/ankle, anorectal, or temporomandibular joint pain, the risk of long-term opioid therapy significantly increased with older age, recent psychiatric diagnoses and surgical history. Surgeons should be aware of these risk factors in order to make high quality clinical decisions in consultations with these patients.

Translating Virtual Reality Cue Exposure Therapy for Binge Eating into a Real-World Setting: An Uncontrolled Pilot Study.

Binge-eating disorder (BED) and bulimia nervosa (BN) have adverse psychological and medical consequences. Innovative interventions, like the integration of virtual reality (VR) with cue-exposure therapy (VR-CET), enhance outcomes for refractory patients compared to cognitive behavior therapy (CBT). Little is known about the feasibility and acceptability of translating VR-CET into real-world settings. To investigate this question, adults previously treated for BED or BN with at least one objective or subjective binge episode/week were recruited from an outpatient university eating disorder clinic to receive up to eight weekly one-hour VR-CET sessions. Eleven of 16 (68.8%) eligible patients were enrolled; nine (82%) completed treatment; and 82% (9/11) provided follow-up data 7.1 (SD = 2.12) months post-treatment. Overall, participant and therapist acceptability of VR-CET was high. Intent-to-treat objective binge episodes (OBEs) decreased significantly from 3.3 to 0.9/week (p < 0.001). Post-treatment OBE 7-day abstinence rate for completers was 56%, with 22% abstinent for 28 days at follow-up. Among participants purging at baseline, episodes decreased from a mean of one to zero/week, with 100% abstinence maintained at follow-up. The adoption of VR-CET into real-world clinic settings appears feasible and acceptable, with a preliminary signal of effectiveness. Findings, including some loss of treatment gains during follow-up may inform future treatment development.

Body Image Disturbance and Obsessive-Compulsive Disorder Symptoms Improve After Orthognathic Surgery.

PURPOSE: Although body image disturbance (BID), anxiety, depression, and obsessive-compulsive disorder (OCD) are the most common comorbid psychological conditions among patients presenting for orthognathic surgery (OS), little is known about whether psychological symptoms relate to facial deformity or how symptoms change after OS. To fill these knowledge gaps, this study investigated preoperative and postoperative psychological symptoms and preoperative baseline facial deformity in patients who underwent OS. PATIENTS AND METHODS: This study included 49 patients who underwent OS by a single surgeon between 2011 and 2018. The patients completed validated psychological tests to assess symptoms of anxiety (Beck Anxiety Inventory), depression (Patient Health Questionnaire-9), BID (BID Questionnaire, BIDQ), and OCD (Florida Obsessive-Compulsive Inventory). In addition, we measured severity of preoperative facial deformity with the Facial Aesthetic Index (FAI). We compared preoperative and postoperative symptoms using univariate nonparametric Wilcoxon signed rank tests. We tested associations between the 4 types of preoperative psychological symptoms and baseline Facial Aesthetic Index category using Spearman's rank correlations. RESULTS: Postoperatively, both BIDQ scores (median 2 to 1.2, P < .001) and Florida Obsessive-Compulsive Inventory scores (median number of OCD symptoms 1 to 0, P < .001) decreased, whereas anxiety and depression symptoms showed no change (P > .45). Preoperative BIDQ was significantly associated with the severity of the facial deformity (ρ = 0.32, P = .025; median BIDQ: mild FAI = 1.0, severe FAI = 2.1). CONCLUSIONS: Our results show that patients with more severe facial deformity have a higher BID preoperatively and that both BID and OCD improve after OS. Interestingly, anxiety and depression symptoms did not change after OS.

Parent-based prevention after parental weight loss surgery: a pilot case-series trial.

BACKGROUND: Overeating and obesity are elevated in children of parents who have undergone weight loss surgery. Parents who have undergone weight loss surgery often report their personal history of obesity interferes with their knowledge, skills, and self-efficacy in developing their children's healthy habits, thus reducing the likelihood of addressing obesogenic environmental factors. OBJECTIVES: This study examines whether a 6-session parent-based prevention after bariatric surgery online intervention is feasible and acceptable for parents. The study also explores the program's signal of efficacy in improving short-term outcomes related to decreased long-term risks for obesity by examining short-term impact on targeted parental cognitions, feeding practices, and child eating behaviors and physical activity habits. SETTING: University Hospital, United States. METHODS: Parents were recruited using flyers, clinician referrals, and social media. Measures assessed parental feeding practices, children's eating behaviors, daily hours of screen time, and outdoor play. RESULTS: Ten families enrolled and 7 completed the study. Parents found the intervention relevant and suitable for addressing their parenting concerns. Parental feeding behaviors, such as restriction and pressure to eat, reduced while tracking of sweets and high-fat snacks increased. Children reduced both emotional overeating and undereating. Children's daily hours of screen time reduced as well as their outdoor play time. CONCLUSIONS: Parent-based prevention after bariatric surgery aimed at helping parents who have undergone weight loss surgery engineer healthier family lifestyles is feasible, acceptable, and associated with reduced obesogenic risk factors.

Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study.

BACKGROUND: Loss of control (LOC) is a pervasive feature of binge eating, which contributes significantly to the growing epidemic of obesity; approximately 80 million US adults are obese. Brain-responsive neurostimulation guided by the delta band was previously found to block binge-eating behavior in mice. Following novel preclinical work and a human case study demonstrating an association between the delta band and reward anticipation, the US Food and Drug Administration approved an Investigational Device Exemption for a first-in-human study. OBJECTIVE: To assess feasibility, safety, and nonfutility of brain-responsive neurostimulation for LOC eating in treatment-refractory obesity. METHODS: This is a single-site, early feasibility study with a randomized, single-blinded, staggered-onset design. Six subjects will undergo bilateral brain-responsive neurostimulation of the nucleus accumbens for LOC eating using the RNS® System (NeuroPace Inc). Eligible participants must have treatment-refractory obesity with body mass index ≥ 45 kg/m2. Electrophysiological signals of LOC will be characterized using real-time recording capabilities coupled with synchronized video monitoring. Effects on other eating disorder pathology, mood, neuropsychological profile, metabolic syndrome, and nutrition will also be assessed. EXPECTED OUTCOMES: Safety/feasibility of brain-responsive neurostimulation of the nucleus accumbens will be examined. The primary success criterion is a decrease of ≥1 LOC eating episode/week based on a 28-d average in ≥50% of subjects after 6 mo of responsive neurostimulation. DISCUSSION: This study is the first to use brain-responsive neurostimulation for obesity; this approach represents a paradigm shift for intractable mental health disorders.

Bringing Virtual Reality From Clinical Trials to Clinical Practice for the Treatment of Eating Disorders: An Example Using Virtual Reality Cue Exposure Therapy.

Novel treatment options for eating disorders (EDs) are critically needed to enhance treatment outcomes and reduce the rates of treatment dropouts. On average, only 50% of individuals receiving evidence-based care remit, whereas 24% drop out before treatment completion. One particularly promising direction involves integrating virtual reality (VR) with existing evidence-based treatments (EBTs) such as cue exposure therapy (CET). Across psychiatric disorders, VR-based interventions are demonstrating at least preliminary efficacy and noninferiority to traditional treatments. Furthermore, VR technology has become increasingly portable, resulting in improved acceptance, increased access, and reductions in cost. However, more efficient research processes may be needed to uncover the potential benefits of these rapid technological advances. This viewpoint paper reviews existing empirical support for integrating VR with EBTs (with a focus on its use with EDs) and proposes key next steps to more rapidly bring this innovative technology-based intervention into real-world clinic settings, as warranted. VR-CET for EDs is used to illustrate a suggested process for developing such treatment enhancements. We recommend following a deployment-focused model of intervention development and testing to enable rapid implementation of robust, practice-ready treatments. In addition, our review highlights the need for a comprehensive clinical protocol that supports clinicians and researchers in the implementation and testing of VR-CET and identifies key missing protocol components with rationale for their inclusion. Ultimately, this work may lead to a more complete understanding of the full potential of the applications and integrations of VR into mental health care globally.

The offspring of parents undergoing a weight loss surgery: a systematic review.

The offspring of parents with obesity are at an increased risk of developing this condition themselves because of genetic and environmental factors. One subgroup that may be at particularly high risk of developing obesity is the offspring of parents who have undergone weight loss surgery (PWLS). To date, little research has focused on these offspring or their parents. This systematic review addresses this gap by integrating available literature and assessing the quality of the evidence. To be included, studies were required to have researched characteristics of the offspring of PWLS or parental feeding practices within this population. After review, 12 studies met inclusion criteria. Findings include evidence for heightened risk of obesity among children of PWLS. However, research suggests these children may experience positive, although time-limited, health outcomes after their parents' surgeries. Quality of the evidence was rated as low, primarily because of the lack of randomized controlled studies and information regarding available interventions specifically targeting this vulnerable population. This review underscores the need for research to improve understanding of PWLS families to better support them and capitalize on postbariatric surgery benefits.

Treating binge eating and food addiction symptoms with low-carbohydrate Ketogenic diets: a case series.

BACKGROUND: Many patients with obesity and comorbid binge eating symptoms present with the desire to lose weight. Although some studies suggest that dietary restriction can exacerbate binge eating, others show dietary restriction is associated with significant reductions in binge eating. The effect of a particular type of dieting on binge eating, the ketogenic diet (a high fat, moderate protein, very low carbohydrate diet), is not known. CASE PRESENTATIONS: We report on the feasibility of a low-carbohydrate ketogenic diet initiated by three patients (age 54, 34, and 63) with obesity (average BMI 43.5 kg/m2) with comorbid binge eating and food addiction symptoms. All patients tolerated following the ketogenic diet (macronutrient proportion 10% carbohydrate, 30% protein, and 60% fat; at least 5040 kJ) for the prescribed period (e.g., 6-7 months) and none reported any major adverse effects. Patients reported significant reductions in binge eating episodes and food addiction symptoms including cravings and lack of control as measured by the Binge-Eating Scale, Yale Food Addiction Scale, or Yale-Brown Obsessive-Compulsive Scale modified for Binge Eating, depending on the case. Additionally, the patients lost a range of 10-24% of their body weight. Participants reported maintenance of treatment gains (with respect to weight, binge eating, and food addiction symptoms) to date of up to 9-17 months after initiation and continued adherence to diet. CONCLUSIONS: Although the absence of control cases precludes conclusions regarding the specific role of ketogenic diets versus other forms of dietary restriction, this is the first report to demonstrate the feasibility of prescribing a ketogenic diet for patients with obesity who report binge eating and food addiction symptoms. Further research should seek to reproduce the observed effects in controlled trials as well as to explore potential etiologies.

Parenting after Weight Loss Surgery: A Conceptual Model and Two Case Reports.

The ways families approach eating, shape, and weight can result in stress for individual family members and challenge the overall functioning of the family. This is further complicated among families with a parent who has history of obesity or undergone weight loss surgery (WLS). Although WLS can positively impact other family members, it can also exacerbate conflicts regarding feeding and weight. Such conflicts can involve uncertainty regarding the extent to which the entire family should make the dietary changes recommended for the post-WLS parent. Conflict might also center on the appropriate level of concern regarding the children's risk of developing (or maintaining) obesity. This paper uses two case examples to describe the application of a specialized, time-limited intervention: Parent-Based Prevention following Bariatric Surgery (PBP-B). The program was developed to address the unique challenges and concerns that arise after, or are exacerbated by, WLS. Each detailed case example illustrates a common child-feeding challenge and the employment of key PBP-B strategies throughout the course of treatment. In the first case, the parent who had undergone WLS believed the family's current eating behaviors were the same as those that had led to her own overeating, obesity, and co-occurring psychiatric symptoms, while her husband disagreed. In the second case, both parents were concerned about their son's weight, yet due to their prior eating histories, they felt unable to construct boundaries around the feeding experience. Both cases follow families through the entire intervention and illustrate key points and challenges. These cases underscore the need for novel treatment modalities to support families following parental WLS.

Las maneras en las que las familias abordan la alimentación, la figura y el peso pueden causar estrés en los integrantes individuales de la familia y poner a prueba el funcionamiento general de la familia. Esto es aun más complicado entre las familias con un padre que tiene antecedentes de obesidad o que se sometió a una cirugía para adelgazar. Aunque la cirugía para adelgazar puede repercutir de manera positiva en otros miembros de la familia, también puede exacerbar conflictos con respecto a la alimentación y al peso. Dichos conflictos pueden consistir en la incertidumbre con respecto al grado en el cual toda la familia debería hacer los cambios alimentarios recomendados para el padre que se ha operado para adelgazar. El conflicto también podría centrarse en el nivel adecuado de preocupación en relación con el riesgo de los niños de desarrollar (o mantener) la obesidad. Este artículo utiliza dos ejemplos de casos para describir la aplicación de una intervención especializada y limitada temporalmente: "La prevención basada en los padres después de una cirugía bariátrica" (Parent-Based Prevention following Bariatric Surgery, PBP-B). El programa se desarrolló para abordar los desafíos y las preocupaciones particulares que surgen después de la cirugía para adelgazar o que son exacerbados por esta. Cada ejemplo de un caso detallado ilustra un desafío común con respecto a la alimentación de los niños y al empleo de estrategias fundamentales de la PBP-B a lo largo del transcurso del tratamiento. En el primer caso, la madre que se había sometido a la cirugía para adelgazar creía que los comportamientos alimentarios actuales de la familia eran los mismos que los que la habían conducido a su propia sobreingesta, obesidad, y síntomas psiquiátricos concomitantes, mientras que su esposo no estaba de acuerdo. En el segundo caso, ambos padres estaban preocupados acerca del peso de su hijo, sin embargo, debido a sus antecedentes alimentarios previos, se sentían incapaces de establecer límites en torno a la experiencia alimentaria. Ambos casos siguen a las familias durante toda la intervención e ilustran puntos clave y desafíos. Estos casos subrayan la necesidad de incorporar modalidades innovadoras de tratamiento orientadas a apoyar a las familias después de la cirugía para adelgazar de uno de los padres.

A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa.

OBJECTIVE: Open trials suggest phentermine/topiramate ER (PHEN/TPM-ER), food and drug administration (FDA) approved for obesity, has utility for binge eating. With no randomized controlled trials (RCTs) yet performed, this trial aimed to evaluate PHEN/TPM-ERs efficacy and safety in a crossover RCT for patients with binge-eating disorder (BED) or bulimia nervosa (BN). METHOD: Participants were randomized to 12-weeks PHEN/TPM-ER (3.75 mg/23 mg-15 mg/92 mg) or placebo followed by 2-weeks drug washout, then 12-week crossover. Demographics, vitals, eating disorder behaviors, mood, and side effects were measured. Primary outcome was objective binge-eating (OBE) days/4-weeks; secondary outcomes included binge abstinence. Mixed-effect models estimated treatment effects, with fixed effects adjusting for treatment, study period, and diagnosis. RESULTS: The 22 adults (BED = 18, BN = 4) were female (96%), Caucasian (55%), aged 42.9 (SD = 10.1) years with body mass index = 31.1 (SD = 6.2) kg/m2 . Baseline OBE days/4-weeks decreased from 16.2 (SD = 7.8) to 4.2 (SD = 8.4) after PHEN/TPM-ER versus 13.2 (SD = 9.1) after placebo (p < .0001), with abstinence rates = 63.6% on PHEN/TPM-ER versus 9.1% on placebo (p < .0001). Weight changes = -5.8 kg on PHEN/ TPM-ER versus +0.4 kg on placebo. Drop-out = 2 (9%) on PHEN/TPM-ER and 2 (9%) on placebo, with few side effects. Vital sign changes with PHEN/TPM-ER were minimal and similar to placebo. Responses were not significantly different for BED versus BN. DISCUSSION: This first RCT to evaluate the efficacy and safety of PHEN/TPM-ER for BED/BN found this drug combination significantly more effective at reducing binge eating than placebo and well tolerated. However, with only four participants with BN, findings regarding the safety of PHEN/TPM-ER in patients with BN must be taken with caution. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824.

Dialectical behavior therapy guided self-help for binge-eating disorder.

Binge-eating disorder (BED) is a prevalent and serious public health issue. BED is characterized by recurrent out-of-control binge eating episodes in the absence of extreme weight control behavior and is associated with significant psychosocial and physiological impairment. Dialectical Behavior Therapy (DBT), based on the affect regulation model of binge eating, is an evidence-based treatment (EBT) approach for BED. Unfortunately, access to EBTs is often limited due to geographical barriers (i.e., lack of local providers with specialized training in EBTs), lack of financial resources, and/or time constraints. Self-help approaches (via guided and unguided versions) to delivering DBT for BED offer a potentially effective means of more widely disseminating this treatment. Compared to traditional, higher intensity approaches, self-help DBT for BED is less time-consuming, less financially costly, and requires less need for specialized therapist-training. This paper will present how DBT for BED has been adapted for self-help delivery, review the limited but promising research on DBT self-help available to date, and provide directions for future research.

Replication and extension of dietary adherence as a predictor of suboptimal weight-loss outcomes in postbariatric patients.

BACKGROUND: Sarwer et al. found that poor dietary adherence at 6 months postoperatively predicted lower weight loss. OBJECTIVES: To replicate and extend these findings. SETTING: University bariatric clinic. METHODS: Fifty-four adults (72% female; age 51.1 ± 11.3 yr; mean body mass index [BMI] = 43.8 ± 7.4 kg/m2; 53.7% = Roux-en-Y gastric bypass, 42.6% = laparoscopic sleeve gastrectomy, and 3.7% = gastric banding) were identified as low or high dietary adherers following the method of Sarwer et al. Patients self-reported dietary adherence with a 9-point Likert scale. Splitting the group at the median, low adherers scored <7 and high dietary adherers ≥7. BMI, percentage excess weight loss (%EWL), and percentage total weight loss (%TWL) were prospectively assessed at 12, 24, and 36 months. Two-tailed independent t tests and Cohen's d effect sizes were used to compare between-group outcomes. RESULTS: BMI did not differ between low (n = 24) and high (n = 30) dietary adherers at 6 months after surgery. At 12 months, the BMI of low (n = 17) adheres was significantly higher (34.1 ± 4.61 versus 30.3 ± 3.90 kg/m2, P = .006, d = 0.90) than that of high (n = 25) adherers, with significantly less %EWL (49.0 ± 24% versus 70.7 ± 21.5%; P = .004; d = 0.95) and %TWL (20.7 ± 11.5% versus 28.9 ± 10.5, P = .02, d = 0.74). At 24 months, BMI remained significantly higher for low (n = 12) versus high (n = 10) adherers (33.7 ± 4.77 versus 29.7 ± 3.82 kg/m2, P = .045, d = 0.92), but %EWL and %TWL were not significantly different, despite large effect sizes. At 36 months, moderate effects supported continued higher BMIs and lower %EWL and %TWL for low (n = 5) versus high (n = 8) adherers. Attrition from follow-up was 22.2% (12 mo), 59.3% (24 mo), and 75.9% (36 mo). Post hoc analyses revealed no impact of baseline characteristics on low follow-up rates except younger age (at 1 yr). CONCLUSIONS: Findings that 6-month postoperative dietary adherence predicts 12-month BMI, %EWL, and %TWL were replicated. Medium to large effects suggest findings extend to 24 and 36 months, with low follow-up rates likely affecting statistical significance.

Correlates of Dietary Adherence and Maladaptive Eating Patterns Following Roux-en-Y Bariatric Surgery.

BACKGROUND: Self-reported poor dietary adherence following bariatric surgery is associated with less successful weight loss outcomes. Poor dietary adherence is a global construct lacking specificity regarding its underlying, clinically targetable, maladaptive eating behaviors. METHODS: Comprehensive online survey data were obtained from a sample of 274 adults who underwent Roux-en-Y surgery in the prior 1-12 years. Correlations between dietary adherence and six eating-related behaviors were calculated, with the frequency of each behavior reported on a 7-point scale. Linear regression modeling was applied. RESULTS: All six maladaptive eating behaviors were highly correlated with dietary adherence (Pearson's r > 0.5): grazing (r = - 0.565), mindless eating (r = - 0.572), loss of control eating (r = - 0.517), eating "more than is best" after dinner (r = - 0.518), eating foods off of one's plan (r = - 0.557), and "when I eat something off-plan, I feel like I have blown it and I give up and eat more" (r = - 0.574). The estimated regression coefficients in the linear model was statistically significant, [F(5, 261) = 60.006, p < 0.001] and accounted for approximately 54% of the variance of global dietary adherence (R 2 = 0.535, adjusted R 2 = 0.526). CONCLUSION: Six maladaptive eating behaviors accounted for a highly significant portion of post-Roux-en-Y patients' poor self- reported dietary adherence. Prospective studies are needed to investigate the relationship between targetable maladaptive eating behaviors and bariatric surgery outcomes.

Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.

INTRODUCTION: Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. METHODS: Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. DISCUSSION: To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824.

A Standardized Preoperative Group Intervention Is Feasible and Acceptable to Orthognathic Surgery Patients.

PURPOSE: Nearly 10% of patients remain dissatisfied after orthognathic surgery, largely because of psychoeducational or psychosocial factors. The purpose of this study was to evaluate the feasibility and acceptability of a psychoeducationally based group intervention to improve preoperative preparation of orthognathic surgical patients and their caregivers. MATERIALS AND METHODS: The intervention consisted of 2 group sessions, with each session lasting 2 hours. The sessions provided realistic expectations of the surgery, offered teaching strategies for coping with pre- and postoperative symptoms of psychopathology, and highlighted the importance of social support. Feasibility was based on attendance, homework completion, and data collection rates, and acceptability was based on post-treatment participant satisfaction scores on the Client Satisfaction Questionnaire-8 (CSQ-8) and credibility and expectancy scores on 2 subscales of the Credibility/Expectancy Questionnaire-Modified (CEQ-M). RESULTS: Twenty-six orthognathic surgical patients were recruited from an outpatient oral and maxillofacial surgery clinic to attend the group-based intervention. Seventy percent of patients who attended at least 1 session completed the 2 sessions, and 64% of those who attended the 2 sessions completed at least 1 homework assignment. The authors successfully collected 84% of the total measures given to patients and their caregivers. The mean satisfaction rating of the patients was 30.12 of 32 (CSQ-8; n = 13; standard deviation [SD], 2.33), the mean credibility rating of the patients and their caregivers was 25.2 of 27 (CEQ-M; n = 20; SD, 1.85), and the mean expectancy rating of the patients and their caregivers was 20.54 of 27 (CEQ-M; n = 20; SD, 4.39). CONCLUSION: The psychoeducationally based group intervention was feasible and acceptable for participants and their caregivers. This article offers suggestions to further improve the feasibility and acceptability of the intervention, including optimizing standardization of data collection procedures, decreasing barriers to access, and increasing participant engagement.