Insomnia, Short Sleep, and Their Treatments: Review of Their Associations with Weight.

PURPOSE OF REVIEW: Insomnia and short sleep have been linked with weight gain and obesity. However, these findings have not been consistent across studies. We review recent evidence for the association between insomnia, short sleep, and weight gain, as well as the relationship between behavioral and pharmacological treatments for sleep and weight. RECENT FINDINGS: The relationship between insomnia and obesity is mixed, with stronger associations between insomnia with short sleep and obesity than other presentations of insomnia. Short sleep is associated with weight gain. Z-drugs and benzodiazapines do not appear to impact weight, but many antidepressants and antipsychotics that are used for insomnia treatment do cause weight gain. The relationships between insomnia and short sleep with weight gain and obesity are inconsistent. More prospective trials are needed to identify mediators and moderators of this relationship to better develop and deliver effective interventions for both sleep and weight problems.

Ultra-Processed Food Addiction: A Research Update.

PURPOSE OF REVIEW: Detail recent advancements in the science on ultra-processed food (UPF) addiction, focusing on estimated prevalence rates and emerging health disparities; progress towards identifying biological underpinnings and behavioral mechanisms; and implications for weight management. RECENT FINDINGS: Notable developments in the field have included: (1) estimating the global prevalence of UPF addiction at 14% of adults and 15% of youths; (2) revealing health disparities for persons of color and those with food insecurity; (3) observing altered functioning across the brain-gut-microbiome axis; (4) providing early evidence for UPF withdrawal; and (5) elucidating poorer weight management outcomes among persons with UPF addiction. The breadth of recent work on UPF addiction illustrates continued scientific and public interest in the construct and its implications for understanding and treating overeating behaviors and obesity. One pressing gap is the lack of targeted interventions for UPF addiction, which may result in more optimal clinical outcomes for this underserved population.

Psychopathology, disordered eating, and impulsivity as predictors of weight loss 24 months after metabolic and bariatric surgery.

BACKGROUND: The relationship between theoretically relevant psychosocial and behavioral variables and outcomes of metabolic and bariatric surgery remains unclear. Some studies have found that the presence of psychopathology, disordered eating, and impulsivity, either before surgery or during the early postoperative period, is associated with suboptimal postoperative weight loss. Other studies have not found these relationships. OBJECTIVE: Examine the relationship between psychopathology, disordered eating, impulsivity, and weight loss 24 months postoperatively. SETTING: Two large, urban university health systems. METHODS: Participant characteristics were collected using validated interviews, patient-reported outcome measures, and computerized assessment methods. Linear mixed effect models were used to test the association of the variables of interest on percent weight loss (%WL). RESULTS: Three hundred participants were enrolled at baseline; weight data at 24 months were available for 227 participants; between 181 and 53 individuals completed other outcome measures. The mean %WL was 23.3 ± 9.9% at 24 months. Patients who underwent Roux-en-Y gastric bypass lost more weight than those who underwent sleeve gastrectomy. The presence of subjective binge episodes at baseline was related to a greater %WL at 24 months; there were no other baseline predictors. The presence of eating disorder diagnoses and disordered eating symptoms after surgery were associated with smaller weight losses over 24 months. Current and lifetime psychopathology and impulsivity were unrelated to %WL at 24 months. CONCLUSION: Disordered eating after bariatric surgery was associated with a smaller %WL at postoperative year 2. Additional monitoring of these symptoms in the early postoperative period is recommended. Psychotherapeutic and/or dietary interventions may promote more optimal weight loss outcomes.

Gamification to Promote Physical Activity in Youth and Mothers With Obesity.

PURPOSE: Physical inactivity and sugar-sweetened beverage (SSB) consumption are associated with obesity. Gamification and self-monitoring to promote physical activity in youth is unknown, but evidence of effectiveness is present in adults. This study examined the effects of a gamification intervention on increased steps per day among parent-adolescent dyads with obesity compared with digital self-monitoring and if self-monitored SSB intake differed between these arms. METHODS: Youth ages 10-16 years and their mothers (N = 39 pairs), both with obesity, were randomized to a self-monitoring (N = 18) or a self-monitoring plus gamification arm (N = 21) for 9 weeks. The step goal was set and incrementally increased each week and was measured with Fitbit devices. Mixed effects linear regression examined changes in steps and SSB consumption per day, per week by study arm. RESULTS: During run-in, mothers averaged 8317 and youth 7508 steps per day. Compared with self-monitoring alone, gamification did not increase daily steps in mothers or youth beyond baseline levels. On average, SSB intake decreased in mothers by approximately 0.5 servings per day; occurred in both arms and persisted throughout the intervention. CONCLUSION: Gamification did not promote physical activity levels in mother-youth dyads with obesity. SSB intake declined in mothers with obesity in both study arms.

A pilot randomized controlled trial of liraglutide 3.0 mg for binge eating disorder.

Objective: To assess the efficacy of liraglutide 3.0 mg, a glucagon-like peptide-1 (GLP-1) receptor agonist, for binge eating disorder (BED). Methods: Adults with a body mass index (BMI) ≥ 27 kg/m2 enrolled in a pilot, 17-week double-blind, randomized controlled trial of liraglutide 3.0 mg/day for BED. The primary outcome was number of objective binge episodes (OBEs)/week. Binge remission, weight change, and psychosocial variables were secondary outcomes. Mixed effect models were used for continuous variables, and generalized estimating equations were used for remission rates. Results: Participants (n = 27) were 44.2 ± 10.6 years; BMI = 37.9 ± 11.8 kg/m2; 63% women; and 59% White and 41% Black. At baseline, the liraglutide group (n = 13) reported 4.7 ± 0.7 OBEs/week, compared with 3.0 ± 0.7 OBEs/week for the placebo group, p = 0.07. At week 17, OBEs/week decreased by 4.0 ± 0.6 in liraglutide participants and by 2.5 ± 0.5 in placebo participants (p = 0.37, mean difference = 1.2, 95% confidence interval 1.3, 2.0). BED remission rates of 44% and 36%, respectively, did not differ. Percent weight loss was significantly greater in the liraglutide versus the placebo group (5.2 ± 1.0% vs. 0.9 ± 0.7%, p = 0.005). Conclusion: Participants in both groups reported reductions in OBEs, with the liraglutide group showing clinically meaningful weight loss. A pharmacy medication dispensing error was a significant limitation of this study. Further research on liraglutide and other GLP-1 agonists for BED is warranted.

Changes in Eating Behaviors and Their Relation to Weight Change 6 and 12 Months After Bariatric Surgery.

INTRODUCTION: Identifying eating behaviors associated with suboptimal weight loss following bariatric surgery remains important. This study assessed the relationship between eating behaviors and weight loss following bariatric surgery in a racially diverse sample. METHODS: Participants were assessed before surgery and 6 and 12 months postoperatively, with the Structured Clinical Interview for DSM-5, the Eating Disorder Examination-Bariatric Surgery Version, and validated measures assessing a range of eating behaviors. Linear mixed effect models were used to test the impact of eating behaviors on percent weight loss (%WL) at 6 and 12 months. RESULTS: We enrolled 300 participants (mean age 40.1 years; BMI 45.9 kg/m2; 87% women; 62% Black and 30% White). The majority (82%) underwent sleeve gastrectomy (SG). Mean %WL was 23.0 ± 5.1% at 6 months and 26.2 ± 7.6% at 12 months. Subjective binge episodes prior to surgery predicted greater %WL over the first 12 postoperative months (p = 0.028). Postoperative disinhibition, hunger, night eating symptoms, objective binge episodes, global disordered eating attitudes and behaviors, and snacks per day were associated with smaller %WL over 12 months (all p's < 0.01). The presence of picking/nibbling and addictive-like eating behaviors was not associated with %WL at the end of the first postoperative year. CONCLUSION: Among a diverse participant sample, problematic eating behaviors following surgery were associated with smaller %WL over 12 months. Postoperative assessment and treatment of eating behaviors are needed to address these issues as they arise and to prevent attenuation of early weight loss in some patients.

Awareness of link between obesity and breast cancer risk is associated with willingness to participate in weight loss intervention.

PURPOSE: To assess knowledge of obesity-associated cancer risk, self-awareness of BMI status, and willingness to engage in weight loss intervention in breast cancer survivors with overweight and obesity as a companion study for a novel weight loss program using a telehealth platform (NCT04855552). METHODS: Breast cancer survivors with BMI ≥ 25 kg/m2 were surveyed to assess self-perception of BMI, knowledge of obesity-related cancer risk, and willingness to participate in weight loss programs. Multivariable logistic regression was used to assess factors associated with willingness to participate. RESULTS: Of the 122 participants, 73 (59.8%) had BMI 25.0-29.9 kg/m2 (overweight) and 49 (40.2%) had BMI ≥ 30 (obesity). Patients with obesity were more likely to underestimate their BMI than those with overweight, 40.8% vs. 23.3% (p = 0.03). The majority (82.0%) indicated awareness that obesity increases breast cancer risk and 57.4% expressed interest in a weight loss program. Patients with knowledge of obesity-related breast cancer risk (91.4% willing vs. 69.2% not willing, p < 0.01) were more willing to participate in a weight loss program on univariable and multivariable analyses (p < 0.01). CONCLUSION: Our results underscore the importance of raising patients' awareness of obesity-related health risks and individual BMI category. Future work in the development of better education and communication tools to improve awareness will likely improve the adoption rate of healthy lifestyles in at-risk patients.

Binge eating disorder and eating self-efficacy in adults seeking bariatric surgery.

This study assessed the relationships between binge eating disorder (BED) and eating self-efficacy in a sample of patients prior to bariatric surgery. The study also examined the extent that BED status accounted for variance in self-efficacy after controlling for demographic factors (age, sex and race), physical variables (comorbidities and body mass index [BMI]) and depressive symptoms. This was a cross-sectional study of pre-surgical data from patients seeking bariatric surgery at a university-based healthcare system (N = 98; mean ± SD age of 46.2 ± 12.5 years; BMI of 45.4 ± 7.2 kg/m2 ; 86.7% female; and 60.2% of patients self-identified as White). Patients completed the Weight and Lifestyle Inventory (WALI), Beck Depression Inventory-II (BDI-II) and Weight Efficacy Lifestyle Questionnaire. Of the total sample, 15.3% met criteria for BED, 33.7% had subthreshold BED and 51.0% were free of this disorder. In adjusted analyses, total self-efficacy was significantly lower in patients with subthreshold BED (B ± SE = -15.88 ± 7.23, p = .03) and individuals with BED (B ± SE = -35.07 ± 10.23, p = .001) than in those without BED. Patients with BED, compared to those without, had significantly worse scores (in adjusted analyses) on the self-efficacy subscales of negative emotions (p = .003), availability of food (p < .001), social pressure (p = .004) and positive activities (p = .03). In patients seeking bariatric surgery, total self-efficacy scores were significantly lower in patients with BED and subthreshold BED than those without BED. The results suggest that eating self-efficacy may be an important factor to target in patients with BED who seek bariatric surgery.

Binge size and loss of control as correlates of eating behavior and psychopathology among individuals with binge eating disorder and higher weight.

Studies comparing individuals with loss of control (LOC) eating who do and do not have objectively large binge episodes have found that degree of LOC is more important than binge size to psychological and behavioral outcomes. However, the relative importance of these characteristics has not been investigated in a population with binge eating disorder (BED), who by definition all have objectively large binge episodes. Persons with BED and higher weight (N = 34) were enrolled in a BED treatment trial and completed the Loss of Control Over Eating Scale, the Eating Disorder Examination, and measures of eating behavior, mood, and quality of life. Body mass index (BMI) was calculated from measured height and weight. The size of the largest binge episode (measured in kilocalories) and degree of LOC were entered into multiple regression equations to determine their relationships with disordered eating symptoms, depression, quality of life, and BMI in this pilot study. Greater LOC had a stronger independent association than binge size with higher total eating psychopathology, shape dissatisfaction, hunger, food cravings and food addiction symptoms. Larger binge size had a stronger independent association than LOC with higher weight concern and lower general and social quality of life. Both characteristics were associated with higher eating concern and neither were associated with depression or BMI. Both binge size and degree of LOC are associated with important psychosocial treatment targets in patients with BED. Future research should validate the largest binge episode measurement method and replicate the present findings in a larger sample.

Development and validation of the Chrononutrition Profile - Diary.

The circadian timing of food intake (i.e., chrononutrition) has been linked to various markers of health status, such as body weight and insulin sensitivity. However, a valid assessment of day-to-day, within-person patterns in chrononutrition has not yet been developed. This paper details the development and initial validity testing of the Chrononutrition Profile - Diary (CP-D). The CP-D assesses 6 components of chrononutrition that are likely to influence health (breakfast skipping, largest meal, evening eating, evening latency, night eating, and eating window). This measure demonstrated preliminary evidence of convergent validity with the ASA24 (Automated Self-Administered 24-hour dietary assessment tool). The CP-D is designed for use by both healthcare professionals and researchers. It can serve as an independent assessment of day-to-day patterns of chrononutrition, and can also be used along with existing dietary measures to provide a comprehensive assessment of participants' and patients' daily eating behaviors and meal timing patterns.

A cross-sectional examination of reported changes to weight, eating, and activity behaviors during the COVID-19 pandemic among United States adults with food addiction.

Prior studies have demonstrated the effects of the COVID-19 pandemic on weight management and lifestyle behaviors, though identification of who may be at greatest risk for negative consequences has not been fully explored. Addictive-like eating behavior, or food addiction, has been associated with an array of problematic eating behaviors, which may suggest heightened susceptibility to poorer outcomes. In this online, cross-sectional study, adults (ages 18-78; M = 42.36, SD = 13.08) living in the United States (n = 288) completed questionnaires assessing food addiction and reported changes to their weight, eating, and physical activity before and during the COVID-19 pandemic. Individuals with food addiction gained an average of 12.42 lb (5.63 kg) since March 2020, compared to an average weight gain of 2.14 lb (0.97 kg) for those without food addiction (p < .001). Linear regression analyses controlling for age and body mass index (BMI) showed that food addiction was independently associated with higher weight gain (B = 9.28, t = 4.97, p < .001), greater intake of ultra-processed foods before and during COVID-19 (B = 1.08, t = 5.71, p < .001; B = 1.18, t = 6.42, p < .001, respectively), greater attribution of their overall current eating behaviors to COVID-19 circumstances (B = 23.19, t = 4.62, p < .001), and higher distress about their overall current eating behaviors (B = -22.12, t = -2.50, p = .01). Interaction effects demonstrated that individuals with food addiction who are older may be at particularly high risk for weight gain and distress. The present research suggests that food addiction is a uniquely meaningful phenotype, beyond the effects of BMI, to identify risk for the negative consequences of COVID-19. Individuals with food addiction, particularly those who are older, may benefit from support with weight management and addictive-like eating as the COVID-19 pandemic persists and resolves.

Racial differences in anxiety, depression, and quality of life in women with polycystic ovary syndrome.

OBJECTIVE: To evaluate racial differences in the anxiety and depression prevalence and scores in women with polycystic ovary syndrome (PCOS). DESIGN: Cross-sectional. SETTING: Academic institution. PATIENTS: Reproductive-aged women with PCOS (n = 272) and controls (n = 295). INTERVENTIONS: Hospital anxiety and depression scale and modified PCOS quality-of-life survey (MPCOS-Q). MAIN OUTCOME MEASURES: Differences in depression and anxiety scores and quality-of-life score measured using the hospital anxiety and depression scale and MPCOS-Q were determined between White and Black women with PCOS. Multivariable correlation regressions assessed the association of the Ferriman-Gallwey score, total testosterone, body mass index (BMI), and homeostatic model assessment of insulin resistance with anxiety, depression, and quality-of-life scores. RESULTS: Multivariable regression controlling for age, BMI, and socioeconomic status showed that White women with PCOS had a significantly higher prevalence of anxiety than Black women with PCOS (75.9% vs. 61.3%) and significantly higher anxiety scores (mean ± SD, 10.3 ± 4.1 vs. 8.7 ± 4.6). The prevalence of depression (24.4% vs. 29%) and depression scores (4.8 ± 3.6 vs. 5.1 ± 4.0) was not significantly different. In multivariable correlation regressions, the interaction between BMI and race in its association with anxiety scores was significant. The association of race with Ferriman-Gallwey score, total testosterone, or homeostatic model assessment of insulin resistance was not significant. In multivariable models, although the total MPCOS-Q scores were similar, the infertility domain was significantly lower in Black women with PCOS (mean ± SD, 12.6 ± 7.8 vs. 17.5 ± 6.8) indicating a lower quality of life related to infertility. CONCLUSION: Racial differences identified in the prevalence of anxiety and MPCOS-Q domains suggest the importance of routine screening and provide an opportunity for targeted interventions based on race.

The nature of night eating syndrome: Using network analysis to understand unique symptomological relationships.

OBJECTIVES: Despite the initial characterization of night eating syndrome (NES) in 1955, the definition and operationalization of its symptoms has varied considerably. To standardize the definition of NES and its symptoms, Allison et al. developed research diagnostic criteria. Even so, conceptualization and intervention of NES remains guided by medical models, which assume that pathology is driven by a distinct, underlying causal mechanism. Conversely, recent work on other eating disorders (EDs) has used network analysis to reconceptualize ED psychopathology and treatment by identifying (a) unique relationships between key symptoms, and (b) the symptoms most central to specific EDs. The present study examined NES symptoms through network analysis to identify the most central symptoms within the NES network. METHOD: Regularized partial correlation networks were estimated using 144 individuals in a community sample diagnosed with NES. Participants completed semi-structured interviews, self-report measures, and food/sleep diaries to measure NES symptoms, nonspecific health domains (e.g., sleep disturbance, overall mood, stress, and circadian rhythm functioning), and transdiagnostic ED symptoms. RESULTS: Depressed mood, poor sleep quality, and a strong urge to eat upon awakening at night were highly central to the psychopathology network for NES and were significantly more central than most other NES symptoms and nonspecific health domains. DISCUSSION: This study provides insight on the unique symptomological relationships of NES and sets the stage for future work that can identify causal linkages among NES symptoms. These symptoms represent key elements of the core psychopathology of NES and should represent primary targets for intervention.

Psychopathology, disordered eating, and impulsivity in patients seeking bariatric surgery.

BACKGROUND: Most patients who undergo bariatric surgery experience significant weight loss and improvements in obesity-related co-morbidities in the first 6-18 months after surgery. However, 20%-30% of patients experience suboptimal weight loss or significant weight regain within the first few postoperative years. Psychosocial functioning may contribute to suboptimal weight loss and/or postoperative psychosocial distress. OBJECTIVE: Assess psychosocial functioning, eating behavior, and impulsivity in patients seeking bariatric surgery. SETTING: Two university hospitals. METHODS: Validated interviews and questionnaires. Impulsivity assessed via computer program. RESULTS: The present study included a larger (n = 300) and more racially diverse (70% non-White) sample than previous studies of these relationships. Forty-eight percent of participants had a current psychiatric diagnosis and 78% had at least 1 lifetime diagnosis. Anxiety disorders were the most common current diagnosis (25%); major depressive disorder was the most common lifetime diagnosis (44%). Approximately 6% of participants had a current alcohol or substance use disorder; 7% had a positive drug screen before surgery. A current psychiatric diagnosis was associated with greater symptoms of food addiction and night eating. Current diagnosis of alcohol use disorder or a lifetime diagnosis of anxiety disorders was associated with higher delay discounting. CONCLUSION: The study identified high rates of psychopathology and related symptoms among a large, diverse sample of bariatric surgery candidates. Psychopathology was associated with symptoms of disordered eating and higher rates of delay discounting, suggesting impulse control issues.

Prolonged, Controlled Daytime versus Delayed Eating Impacts Weight and Metabolism.

A delayed eating schedule is associated with increased risk of obesity and metabolic dysfunction in humans.1-9 However, there are no prolonged, highly controlled experimental studies testing the effects of meal timing on weight and metabolism in adults with a body mass index (BMI) of 19-27 kg/m2.10-18 Twelve healthy adults (age: 26.3 ± 3.4 years; BMI: 21.9 ± 1.7 kg/m2; 5 females) participated in a randomized crossover study in free-living conditions. Three meals and two snacks with comparable energy and macronutrient contents were provided during two, 8-week, counterbalanced conditions separated by a 2-week washout period: (1) daytime (intake limited to 0800 h-1900 h) and (2) delayed (intake limited to 1200 h-2300 h). Sleep-wake cycles and exercise levels were held constant. Weight, adiposity, energy expenditure, and circadian profiles of hormones and metabolites were assessed during four inpatient visits occurring before and after each condition. Body weight, insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR]), trunk-to-leg fat ratio, resting energy expenditure, respiratory quotient, and fasting glucose, insulin, total and high-density lipoprotein (dHDL) cholesterol, and adiponectin decreased on the daytime compared to the delayed schedule. These measures, as well as triglycerides, increased on the delayed compared to the daytime schedule (effect size range: d = 0.397-1.019). Circadian phase and amplitude of melatonin, cortisol, ghrelin, leptin, and glucose were not differentially altered by the eating schedules. Overall, an 8-week daytime eating schedule, compared to a delayed eating schedule, promotes weight loss and improvements in energy metabolism and insulin in adults with BMI 19-27 kg/m2, underscoring the efficacy and feasibility of daytime eating as a behavioral modification for real-world conditions.

Lifestyle modifications alone or combined with hormonal contraceptives improve sexual dysfunction in women with polycystic ovary syndrome.

OBJECTIVE: To describe the prevalence of female sexual dysfunction in a well-defined polycystic ovary syndrome (PCOS) population, and to assess the impact of common PCOS treatments on sexual function. DESIGN: Secondary analysis of a randomized controlled trial, oral contraceptive pills and weight loss in PCOS. SETTING: Two academic medical centers. PATIENTS: Women with PCOS (N = 114) defined by the Rotterdam criteria. INTERVENTIONS: Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks. MAIN OUTCOME MEASURES: Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) scores after 16 weeks. RESULTS: There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period. Overall, 33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55). Among this group, FSFI score improved after 16 weeks of Lifestyle and Combined treatments. There was no change in prevalence of sexual dysfunction in treatment groups at 16 weeks. Use of OCPs did not alter FSFI scores. CONCLUSION(S): Female sexual dysfunction is highly prevalent among women with PCOS. Our findings suggest that common treatments for PCOS, including intensive lifestyle modification and the combination of intensive lifestyle modification and OCPs, have the potential to improve sexual function in these women; the mechanism for these improvements is likely multifactorial. CLINICAL TRIAL REGISTRATION NUMBER: NCT00704912.

Effects of Oral Contraception and Lifestyle Modification on Incretins and TGF-ß Superfamily Hormones in PCOS.

OBJECTIVE: To examine the effects of common treatments for polycystic ovary syndrome (PCOS) on a panel of hormones (reproductive/metabolic). DESIGN: Secondary analysis of blood from a randomized controlled trial of three 16-week preconception interventions designed to improve PCOS-related abnormalities: continuous oral contraceptive pills (OCPs, N = 34 subjects), intensive lifestyle modification (Lifestyle, N = 31), or a combination of both (Combined, N = 29). MATERIALS AND METHODS: Post-treatment levels of activin A and B, inhibin B, and follistatin (FST), as well as Insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 2 (IGFBP-2), glucagon, glucagon-like peptide 1 (GLP-1) and 2, and oxyntomodulin were compared to baseline, and the change from baseline in these parameters were correlated with outcomes. RESULTS: Oral contraceptive pill use was associated with a significant suppression in activin A, inhibin A, and anti-mullerian hormone (AMH), but a significant increase in FST. IGF-1, IGFBP-2, glucagon, and GLP-2 levels were significantly decreased. Oxyntomodulin was profoundly suppressed by OCPs (ratio of geometric means: 0.09, 95% confidence interval [CI]: 0.05, 0.18, P < 0.001). None of the analytes were significantly affected by Lifestyle, whereas the effects of Combined were similar to OCPs alone, although attenuated. Oxyntomodulin was significantly positively associated with the change in total ovarian volume (rs = 0.27; 95% CI: 0.03, 0.48; P = 0.03) and insulin sensitivity index (rs = 0.48; 95% CI: 0.27, 0.64; P < 0.001), and it was inversely correlated with change in area under the curve (AUC) glucose [rs = -0.38; 95% CI: -0.57, -0.16; P = 0.001]. None of the hormonal changes were associated with live birth, only Activin A was associated with ovulation (risk ratio per 1 ng/mL increase in change in Activin A: 6.0 [2.2, 16.2]; P < 0.001). CONCLUSIONS: In women with PCOS, OCPs (and not Lifestyle) affect a wide variety of reproductive/metabolic hormones, but their treatment response does not correlate with live birth.

Is there an association between body mass index and 21-gene recurrence score?

PURPOSE: The 21-gene recurrence score (RS) is an established predictor of recurrence for early stage, hormone receptor positive breast cancer. The association between RS and other risk factors such as obesity has not been fully explored. We hypothesized that patients with obesity may present with primary breast cancers with higher recurrence scores. METHODS: We identified 1546 patients who have body mass index (BMI) recorded around the time of RS assay. Obesity was classified as per CDC definitions of overweight (BMI 25-30 kg/m2) and obesity (BMI >30 kg/m2). RS was assessed as a continuous variable and according to pre- and post-TAILORx classifications. Kaplan Meier survival analysis was employed to assess the interaction between RS and BMI on overall survival (OS) and disease-free survival (DFS). RESULTS: In univariate analyses, the median RS in patients with overweight was 15, which was significantly lower than the median RS (16) of patients with normal weight (p = 0.03). The overall recurrence rate of patients with obesity was 4.1%, which was significantly worse than the overall recurrence rate of patients with normal and overweight of 2.6% and 1.5%, respectively (p = 0.05). In multivariate analyses using the inverse probability weighted regression adjustment (IPWRA) method to adjust for imbalances between subgroups, patients with overweight or obesity had significantly lower RS than patients with normal weight, correlating to an average decrease in RS value of 2.37 and 1.71, respectively (both p < 0.01). A similar relationship was seen between BMI categories and RS as a categorical variable stratified according to pre- or post-TAILORx categories. This inverse effect was predominantly seen in post-menopausal patients. Despite the generally lower RS in patients with obesity, a high RS in these patients is associated with diminished DFS (p = 0.04). CONCLUSION: Tumors in post-menopausal women with higher BMI generally have lower RS. DFS is significantly worse in women with obesity whose RS ≥ 30. The reasons for poor outcomes for postmenopausal patients with obesity despite lower presenting RS merits further study.