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| Hauptverfasser: | , , , , , , , , , , , , |
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| Format: | Artículo Open Access |
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Wiley
2025
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| Online-Zugang: | https://onlinelibrary.wiley.com/doi/10.1002/oby.70070 |
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Inhaltsangabe:
- Application of the Lancet Commission Criteria for the Diagnosis of Obesity to a Clinical Trials Population: The LEAP Trial Faith Anne N. Heeren Kathleen R. Ruddiman Courtney Simmons Brian N. White Byron C. Jaeger Nicholas M. Pajewski Stephanie A. Hooker Deborah B. Horn Katy Martin‐Fernandez Kimberly A. Gudzune Caroline Blackwell Young Jamy Ard Kristina Henderson Lewis Obesity ABSTRACT Objective This study aimed to apply The Lancet Diabetes & Endocrinology criteria for diagnosing obesity among clinical trial participants and understand participants' characteristics by obesity status. Methods The criteria were operationalized and applied to baseline data from the Long‐term Effectiveness of the Anti‐obesity medication Phentermine (LEAP) trial (NCT05176626). Excess adiposity, organ and tissue dysfunction, and limitations to daily activities were assessed. We examined differences between participants with “no obesity,” “pre‐clinical obesity,” and “clinical obesity.” Results Among the 860 participants, 0.8% had no obesity (mean BMI 29.0 kg/m 2 [SD 0.6]), 18.7% had pre‐clinical obesity (mean BMI 35.2 kg/m 2 [SD 3.5]), and 80.5% had clinical obesity (mean BMI 35.9 kg/m 2 [SD 4.3]). Participants with no/pre‐clinical obesity had lower mean SF‐12 mental component scores and greater baseline engagement with weight control strategies compared to those with clinical obesity. Participants with clinical obesity were older and, by definition, had a greater burden of cardiometabolic risk factors. Conclusions Among clinical trial participants eligible for obesity pharmacotherapy, 19.5% were classified as having no/pre‐clinical obesity using the Lancet criteria. Applying the criteria was complicated in a well‐resourced trial setting, which suggests potential challenges in implementing these guidelines in real‐world practice. 10.1002/oby.70070 http://creativecommons.org/licenses/by/4.0/