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Examining the Omission of Dietary Quality Data in Glucagon-Like Peptide 1 Clinical Trials: A Scoping Review
Demsina Babazadeh1, Shawna Wyatt1, Francene M Steinberg1
1Department of Nutrition, University of California Davis, Davis, CA, United States.
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.
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