Catherine G Coughlin, Emilie S Zoltick, Fatima Cody Stanford, Mei-Sing Ong
{"title":"Racial and ethnic disparities in clinical trials for pediatric obesity.","authors":"Catherine G Coughlin, Emilie S Zoltick, Fatima Cody Stanford, Mei-Sing Ong","doi":"10.1002/oby.24228","DOIUrl":"https://doi.org/10.1002/oby.24228","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to examine the representation of historically marginalized racial and ethnic groups in pediatric obesity clinical trials.</p><p><strong>Methods: </strong>We performed a cross-sectional analysis of clinical trials in pediatric obesity (participants aged ≤18 years) that were registered in ClinicalTrials.gov, were completed from January 2013 to August 2023, and were conducted in the United States. We quantified disparities in trial enrollment by calculating the enrollment-prevalence disparity (EPD) for each racial and ethnic group.</p><p><strong>Results: </strong>A total of 260 trials met eligibility criteria, of which 128 trials (49.2%) reported race and/or ethnicity data. Enrollment of White, Hispanic, and Black children roughly reflects disease burden in these populations. However, relative to disease burden, Asian (EPD, -3.7%; IQR, -3.7% to 1.8%; p < 0.0001), American Indian and Alaska Native (EPD, -2.1%; IQR, -2.1% to -2.1%; p < 0.0001), and Native Hawaiian or other Pacific Islander (EPD, -0.6%; IQR, -0.6% to -0.6%; p < 0.0001) children were significantly underrepresented in these trials.</p><p><strong>Conclusions: </strong>With the exception of Black and Hispanic children, historically marginalized racial groups were underrepresented in pediatric obesity trials, signifying a need to improve diversity of participants in these trials. Additionally, there are substantial gaps in the documentation of race and ethnicity information. Concerted efforts are needed to ensure adequate reporting of race and ethnicity information in clinical trials.</p>","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jamy D Ard, Donna H Ryan, Patrick M O'Neil, Robert F Kushner, Holly R Wyatt, Harold E Bays, Frank L Greenway, John M Jakicic, Sharon Leonard, Yael Kenan, Eti Ganon-Elazar, Thomas A Wadden
{"title":"Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized RESET study.","authors":"Jamy D Ard, Donna H Ryan, Patrick M O'Neil, Robert F Kushner, Holly R Wyatt, Harold E Bays, Frank L Greenway, John M Jakicic, Sharon Leonard, Yael Kenan, Eti Ganon-Elazar, Thomas A Wadden","doi":"10.1002/oby.24240","DOIUrl":"https://doi.org/10.1002/oby.24240","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to investigate the efficacy and safety of the Epitomee capsule versus placebo as an adjunct to high-intensity lifestyle intervention in participants with overweight or obesity.</p><p><strong>Methods: </strong>The Randomized Evaluation of Efficacy and Safety of the Epitomee Capsule Trial (RESET) was a prospective, double-blind, placebo-controlled pivotal trial in adults with baseline BMI of 27.0 to 40.0 kg/m<sup>2</sup>. The co-primary endpoints at week 24 were percentage change from baseline in body weight for the Epitomee and placebo groups and proportion of Epitomee-treated patients achieving ≥5% weight loss compared with a 35% threshold. The primary safety endpoint was the incidence of device-related serious adverse events.</p><p><strong>Results: </strong>A total of 138 participants received Epitomee and 141 received placebo. Mean (SD) change in body weight from baseline was -6.6% (6.5%) with Epitomee and -4.6% ( 4.7%) with placebo; least-squares means were -6.1% (0.6%) and -4.2% (0.6%), respectively (p = 0.0054). Fifty-six percent of Epitomee-treated participants attained ≥5% weight loss from baseline, which was significantly greater than the 35% predefined threshold (p < 0.0001). Twenty-seven percent of Epitomee-treated and eleven percent of placebo-treated participants achieved ≥10% weight loss. Adverse event rates were similar between the groups. No device-related serious adverse events occurred.</p><p><strong>Conclusions: </strong>The Epitomee capsule is a safe and efficacious nonpharmacological option for weight management with potential broad application in participants with overweight or obesity.</p>","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hadia Nawaz, Haneul Lee, Sumin Kang, Hayoon Kim, Wooki Kim, Gwang-Woong Go
{"title":"Alternate-day fasting enhanced weight loss and metabolic benefits over pair-fed calorie restriction in obese mice.","authors":"Hadia Nawaz, Haneul Lee, Sumin Kang, Hayoon Kim, Wooki Kim, Gwang-Woong Go","doi":"10.1002/oby.24211","DOIUrl":"https://doi.org/10.1002/oby.24211","url":null,"abstract":"<p><strong>Objective: </strong>Both alternate-day fasting (ADF) and calorie restriction (CR) are effective weight loss strategies. However, most individuals find it difficult to adhere to CR. Furthermore, CR can induce an excessive loss of not only fat but also muscle mass. This study aimed to compare the effects of ADF and pair-feeding (PF) CR on metabolic pathways underlying obesity in mice with high-fat diet (HFD)-induced obesity.</p><p><strong>Methods: </strong>Male C57BL/6N Tac mice (n = 10 per group) were fed an HFD for 8 weeks to establish a diet-induced obesity model. Mice were then continued on the HFD with either alternate-day access to food or PF for the next 8 weeks. We measured body weight, adiposity, plasma biomarkers, and molecular mechanisms involving lipolysis and autophagy.</p><p><strong>Results: </strong>Both ADF and PF resulted in comparable weight and fat loss. Compared with PF, ADF showed a significant reduction in liver weight and hepatic triglyceride levels. ADF significantly increased plasma ketone body levels and white adipose tissue lipolysis. Compared with PF, ADF tended to activate autophagy elongation and autophagosome formation, which were insignificant.</p><p><strong>Conclusions: </strong>These findings indicated that ADF is a promising intervention for metabolic diseases, potentially due to its superior efficacy in promoting ketogenesis and lipolysis compared with PF.</p>","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rebecca Palmer, Rebecca H Neiberg, Kristen M Beavers, Steven E Kahn, Denise K Houston, Lynne Wagenknecht, Karen C Johnson, Henry J Pownall, Mark A Espeland
{"title":"Associations between decreases in adiposity and reductions in HbA1c and insulin use in the Look AHEAD cohort.","authors":"Rebecca Palmer, Rebecca H Neiberg, Kristen M Beavers, Steven E Kahn, Denise K Houston, Lynne Wagenknecht, Karen C Johnson, Henry J Pownall, Mark A Espeland","doi":"10.1002/oby.24242","DOIUrl":"https://doi.org/10.1002/oby.24242","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to elucidate associations between adiposity reduction and changes in HbA1c and insulin use among adults with type 2 diabetes and overweight or obesity.</p><p><strong>Methods: </strong>Changes in BMI, waist circumference, and total percent fat mass were obtained over 8 years among 1316 individuals (aged 45-76 years) enrolled in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss. Generalized linear models were used to assess relationships between 5% decreases in adiposity measures with glycated hemoglobin (HbA1c) and insulin use over time.</p><p><strong>Results: </strong>A 5% reduction in total percent fat was associated with 0.15% (95% CI: 0.12%-0.18%) lower mean HbA1c. Similarly, 5% reductions in waist circumference and BMI were also associated with slightly lower mean HbA1c: 0.16% (95% CI: 0.13%-0.19%) and 0.13% (95% CI: 0.11%-0.16%), respectively. These reductions were associated with lower odds of insulin use over time, ranging from 21% lower odds for a 5% reduction in percent body fat to 32% lower odds for 5% reductions in waist circumference and BMI. Associations were evident across subgroups defined by sex, diabetes duration, obesity status, and intervention assignment.</p><p><strong>Conclusions: </strong>Reductions in adiposity are associated with stabilized and slightly lower HbA1c and a marked reduction in the need for insulin therapy. These benefits generalize across clinical subgroups.</p>","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alissa S Chen, Alexandra M Hajduk, Alyssa A Grimshaw, Terri R Fried, Ania M Jastreboff, Kasia J Lipska
{"title":"Efficacy of antiobesity medications for weight reduction in older adults: a systematic review.","authors":"Alissa S Chen, Alexandra M Hajduk, Alyssa A Grimshaw, Terri R Fried, Ania M Jastreboff, Kasia J Lipska","doi":"10.1002/oby.24160","DOIUrl":"https://doi.org/10.1002/oby.24160","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to examine weight reduction and adverse events associated with use of antiobesity medications (AOMs) in older adults ages ≥65 years.</p><p><strong>Methods: </strong>Seven databases were searched for studies evaluating weight reduction of Food and Drug Administration (FDA)-approved AOMs. Studies had to include adults ages ≥65 years with obesity (BMI ≥ 30 kg/m<sup>2</sup> or ≥27 kg/m<sup>2</sup> with one weight-related condition), with independent analysis of weight reduction for adults ages ≥65 years. Two coauthors extracted and evaluated studies for risk of bias using standardized forms.</p><p><strong>Results: </strong>Six experimental studies (five secondary analyses of randomized clinical trial data and one single-arm trial) and two observational studies met inclusion criteria. Seven medications were studied. Sample size of older adults ranged from 13 to 6728. Experimental studies predominantly included patients with concurrent prediabetes or cardiovascular disease. All studies found statistically significant weight reduction between intervention and placebo groups or compared with baseline weight. Few studies reported on adverse events.</p><p><strong>Conclusions: </strong>Limited evidence suggests weight reduction of AOMs in older adults, with the best current evidence for the use of semaglutide in older adults with obesity and cardiovascular disease. Larger, more inclusive studies of older adults are needed to guide clinical care and determine the tolerability of AOMs for older adults.</p>","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142901405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amy H. Auchincloss, M. Mujahid, Mingwu Shen, E. Michos, M. Whitt-Glover, A. D. Diez Roux
{"title":"Neighborhood health-promoting resources and obesity risk (the Multi-Ethnic Study of Atherosclerosis)","authors":"Amy H. Auchincloss, M. Mujahid, Mingwu Shen, E. Michos, M. Whitt-Glover, A. D. Diez Roux","doi":"10.1038/oby.2012.91","DOIUrl":"https://doi.org/10.1038/oby.2012.91","url":null,"abstract":"","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":"5 1","pages":"621 - 628"},"PeriodicalIF":0.0,"publicationDate":"2012-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88538227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Geliebter, D. Atalayer, L. Flancbaum, C. Gibson
{"title":"Comparison of Body Adiposity Index (BAI) and Body Mass Index (BMI) with Estimations of % Body Fat in Clinically Severe Obese Women","authors":"A. Geliebter, D. Atalayer, L. Flancbaum, C. Gibson","doi":"10.1038/oby.2012.187","DOIUrl":"https://doi.org/10.1038/oby.2012.187","url":null,"abstract":"","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":"70 1","pages":"493 - 498"},"PeriodicalIF":0.0,"publicationDate":"2012-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75330250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Fitzgibbon, M. Stolley, L. Schiffer, A. Kong, C. Braunschweig, S. Gomez-Perez, A. Odoms-Young, L. V. Van Horn, K. Christoffel, A. Dyer
{"title":"Family-Based Hip-Hop to Health: Outcome Results","authors":"M. Fitzgibbon, M. Stolley, L. Schiffer, A. Kong, C. Braunschweig, S. Gomez-Perez, A. Odoms-Young, L. V. Van Horn, K. Christoffel, A. Dyer","doi":"10.1038/oby.2012.136","DOIUrl":"https://doi.org/10.1038/oby.2012.136","url":null,"abstract":"","PeriodicalId":94163,"journal":{"name":"Obesity (Silver Spring, Md.)","volume":"189 1","pages":"274 - 283"},"PeriodicalIF":0.0,"publicationDate":"2012-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74608094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}