Examining the Omission of Dietary Quality Data in Glucagon-Like Peptide 1 Clinical Trials: A Scoping Review.

IF 9.2
Demsina Babazadeh, Shawna Wyatt, Francene M Steinberg
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引用次数: 0

Abstract

Injectable antiobesity medications (AOMs), including liraglutide, semaglutide, and tirzepatide, have demonstrated significant efficacy in promoting weight loss and improving glycemic control. However, the extent to which diet and food intake and related eating behaviors are assessed or reported in clinical trials of these agents remains unclear. This scoping review aimed to evaluate the presence and quality of dietary data, nutritional counseling, and related behavioral measures in randomized controlled trials of subcutaneous AOMs. A systematic literature search was conducted in MEDLINE-PubMed through September 2024, with a gap search completed December 2024. Eligible studies included randomized trials investigating liraglutide, semaglutide, or tirzepatide in humans. Studies were screened and extracted in Covidence, with 129 meeting inclusion criteria. Data extraction included AOM being studied, primary outcome, presence and type of nutritional or physical activity counseling, diet intake assessment and tools used, and eating behavior outcomes. Of 129 included studies, 54 evaluated liraglutide, 43 semaglutide, and 22 tirzepatide. Although 57 trials reported lifestyle modification as part of the intervention, 36 recorded diet quality and food intake. Among the 36 studies that collected dietary data, only 10 reported outcomes and half used single-time point assessments like ad libitum meals or buffets. Seventeen trials assessed food cravings or eating behavior using a variety of assessments. Across trials, there was minimal uniformity in outcome reporting, study duration, or counseling frequency, with most trials lacking detailed reporting on nutritional behavior components. Despite the central role of diet in weight regulation, most clinical trials involving AOMs fail to report meaningful diet quality or food intake data. The heterogeneity and underreporting of lifestyle components limit interpretability and generalizability of outcomes. Greater emphasis on standardizing and reporting dietary and behavioral measures is warranted to understand how AOMs interact with real-world nutrition behaviors and to inform comprehensive obesity care.

检查GLP-1临床试验中饮食质量数据的遗漏:一项范围综述。
背景:注射抗肥胖药物(AOMs),包括利拉鲁肽、西马鲁肽和替西帕肽,已经证明在促进体重减轻和改善血糖控制方面有显著的疗效。然而,在这些药物的临床试验中,饮食和食物摄入以及相关饮食行为的评估或报告程度仍不清楚。目的:本综述旨在评估皮下AOMs随机对照试验中饮食数据、营养咨询和相关行为措施的存在和质量。方法:系统检索MEDLINE-PubMed至2024年9月,空白检索于2024年12月完成。符合条件的研究包括调查利拉鲁肽、西马鲁肽或替西帕肽在人体中的随机试验。在covid - 19期间筛选和提取了129项符合纳入标准的研究。数据提取包括正在研究的AOM,主要结果,营养或体育活动咨询的存在和类型,饮食摄入评估和使用的工具,以及饮食行为结果。结果:在纳入的129项研究中,54项评估利拉鲁肽,43项评估西马鲁肽,22项评估替西帕肽。57项试验将生活方式的改变作为干预的一部分,36项试验记录了饮食质量和食物摄入量。在收集饮食数据的36项研究中,只有10项报告了结果,一半使用单时间点评估,如随意用餐或自助餐。17项试验使用各种评估方法来评估食物渴望或饮食行为。在所有试验中,结果报告、研究持续时间或咨询频率的一致性很小,大多数试验缺乏营养行为组成部分的详细报告。结论:尽管饮食在体重调节中起着核心作用,但大多数涉及AOMs的临床试验未能报告有意义的饮食质量或食物摄入数据。生活方式成分的异质性和少报限制了结果的可解释性和普遍性。更强调标准化和报告饮食和行为措施是必要的,以了解AOMs如何与现实世界的营养行为相互作用,并为全面的肥胖护理提供信息。工作意义:本综述确定了注射性AOMs临床试验文献中的一个关键空白,尽管有一致的减肥结果,但很少测量或报道饮食摄入数据。饮食数据的缺乏限制了我们对这些药物如何影响饮食行为的理解,并破坏了为长期成功制定量身定制的营养指导的努力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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